Warehouse Coordinator
PCI Pharma Services job in Rockford, IL
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Position Title: Warehouse Coordinator
Location: Assembly Drive, Rockford, IL 61109
Shift: 3rd shift
Summary of Objective:
Seeking a detail-oriented and organized Warehouse Coordinator to join our warehouse team. The Warehouse Coordinator will play a crucial role in managing, analyzing, and ensuring the efficient flow of materials within the warehouse. This role is responsible for inventory accuracy, forecasting material needs, and collaborating closely with warehouse staff, offsite warehouse, and other departments to support production schedules and ensure timely order fulfillment.
Essential Duties and Responsibilities:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
The essential duties and responsibilities include the following but other duties may be assigned.
Inventory Management & Analysis
Monitor and maintain optimal inventory levels by analyzing usage trends and demand forecasts.
Conduct regular material staging audits to ensure inventory accuracy.
Material Planning & Forecasting
Collaborate with offsite warehouse and production teams to forecast material requirements based on production schedules and customer demands.
Use data-driven insights to support material requisitions and reduce stockouts or overstock situations.
Develop and maintain material planning and replenishment strategies, adjusting as necessary to meet operational needs.
Data Reporting & Documentation
Document and analyze material movements, identifying areas for process improvements.
Track key performance indicators (KPIs) related to inventory accuracy, and offsite warehouse efficiency.
Collaboration with Stakeholders
Coordinate with warehouse, and production partners to ensure timely delivery of materials and resolve any issues affecting material availability.
Work closely with warehouse staff to streamline processes for material delivery, storage, and distribution.
Communicate effectively with production and operations teams to align on material needs and ensure seamless workflow.
Process Improvement
Analyze warehouse workflows and material handling processes, identifying opportunities for efficiency gains and cost savings.
Implement best practices for materials management and contribute to the development of standard operating procedures (SOPs).
Participate in continuous improvement initiatives, such as Lean and Six Sigma projects, to enhance operational efficiency and accuracy.
Strong analytical and problem-solving abilities.
Excellent organizational skills and attention to detail.
Effective communication skills, both written and verbal.
Ability to work independently and collaboratively in a fast-paced environment.
Adaptability to evolving warehouse technology and systems.
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The following are some environmental conditions that one may be exposed to on a daily basis and for various lengths of time.
Work is performed in areas with moderate risk or discomfort that may require special safety precautions, such as wearing protective clothing or gear 3/4 of the day and up.
Work is primarily performed at a desk and/or in an office environment. 3/4 of the day and up.
The noise level in the work environment is typically, moderate.
Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Required:
High School Diploma and/or 3-5 years related experience and/or training.
Basic Mathematical Skills
Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs.
Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables.
Preferred:
Ability to display excellent time management skills.
Ability to display a willingness to make decisions.
Ability to demonstrate attention to detail.
Ability to identify and resolve problems in a timely manner.
Ability to handle multiple demands and work under pressure.
Ability to work efficiently in a fast-paced environment.
Ability to input data into computer utilizing JDE systems.
Ability to be flexible and to adapt to changing conditions quickly.
Ability to implement process improvement initiatives.
For candidates in Illinois: The hiring rate for this position is $19.96 to $22.46 hourly plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), a flexible spending account, and 401(k).
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future
Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
Auto-ApplyLead, Operations Training
PCI Pharma Services job in Rockford, IL
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. **We are PCI.** Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
**3rd shift:**
Job Title: Lead, Operations Training
Department/Group: **Production**
Location: **Assembly**
**Summary of Objective:**
This position is required to work cooperatively with production leadership to uphold high standards for excellence and proper cGMP practices for packaging products, from beginning to end, according to quality and safety compliance, and customer specifications. This position will be the first introduction to the production floor processes and standards, and will need to have the ability to maintain strict performance expectations as defined in current PCI best practice documentation. Creation and revision of best practice training materials will also be an essential function of this role.
**Essential Duties and Responsibilities:** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.
+ Validate and certify the technical capabilities of production line personnel in accordance with the current standardized best practices, defined in company SOPs, Work Instructions, and batch record specifications.
+ Responsible for ensuring production line personnel are certified to the latest certification standards and established best practices.
+ Provide onboarding classroom instruction and training for new hire production floor personnel.
+ Integral team member for changes to current processes and implementations of new equipment.
+ Prepares, updates and distributes appropriate training materials in coordination with production/training leadership.
+ Actively rotate and train on the floor to stay current with processes and maintain certifications.
+ Audit compliance and strictly uphold high standards of excellence during and after training/certification process.
+ Monitor training progression of individuals, and work closely with production management/supervisors to schedule training certifications.
+ Provide clear and constructive feedback to OJT trainers based on observations during certification.
+ Escalate all quality, service, and equipment performance issues to supervision. Promote and maintain a safe work environment.
+ Support 5S throughout the facility.
+ Ensure compliance to company policies and documented best practices. Maintain high levels of cGMP compliance and expect that all 5s principles are followed including material flow and min/max expectations.
+ Facilitate and drive prompt completion of company mandated and role specific Compliance Wire trainings.
+ Participate in regular feedback sessions and progress reviews with managers for continuous training process improvement.
+ Participate in all required professional development courses offered.
+ Perform other duties as assigned by Manager/Supervisor.
+ Attendance to work is an essential function of this position.
**Qualifications:** The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
**Required:**
+ Must be a minimum of Level 2 Line Leader to apply.
+ Consistent high performance in production floor processes and the use of current technology.
+ Basic Mathematical Skills
+ Basic Computer Skills: Ability to perform basic computer tasks and has the ability to operate common computer programs. Proficiency in Microsoft Office Suite preferred.
+ Minimum Professional Proficiency: Ability to speak in a way that allows one to participate effectively in various conversations. Ability to read various types of standard items addressed to general readers.
+ Intermediate Reasoning: Ability to apply common sense understanding to carry out instructions that may be furnished in written, oral, or diagram form. Ability to deal with problems that involve several concrete variables in standardized situations.
**Preferred:**
+ Ability to follow instructions and respond to management direction.
+ Ability to work independently and/or part of a team.
+ Ability to adapt to changing work environments.
+ Ability to demonstrate attention to detail.
**F** **or** **candidates in Illinois:** The hiring rate for this position is $19.96-$22.46 hourly plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k).
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future (*****************
**Equal Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Diversity, Equity, and Inclusion (DEI) are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
Distribution Services Admin
PCI Pharma Services job in Rockford, IL
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
The primary functions of this position are to process shipment requests from external or internal sources, ensuring that all appropriate paperwork has been completed and given to the warehouse team, and to maintain and process international paperwork associated to clinical distribution sales orders.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Process shipment requests by correctly entering and verifying all information into the JDE system
Ensure that all necessary paperwork related to the shipment request has been included with the order sent to the floor for proper pick and pack of the materials.
Creation of proforma invoices (if applicable) to the shipment.
Liaise with the IVRS or other external personnel to ensure proper receipt of requests as well as correct information contained in the request to adequately process the shipment.
Follow-up on delivery confirmation of shipments via the selected courier.
Downloading and management of temperature monitoring devices.
Communication between the distribution project manager and the warehouse, when required to solve issues and/or ensure expedited processing of shipments.
Prepare monthly shipping reports and metrics as requested.
Set up customer addresses for site shipments.
Support the Distribution Project Manager or Distribution Services Manager with any project requirements.
Ensure that all international paperwork related to the shipment request has been included with the order sent to the floor for proper shipment of the material.
Management of proforma invoice templates.
Management of the clinical bulk shipment log.
Schedule pick-up of international shipments with the selected courier.
Liaise with external personnel to ensure correct information contained on the proforma invoice to adequately process the shipment.
Liaise with external personnel to obtain authorization for dispatch and confirmation of import permission
Follow-up on delivery confirmation of international shipments via the selected courier.
Prepare monthly metrics as requested.
Assist with the preparation of monthly customer billing and invoicing
This position may require overtime and/or weekend work.
Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
Attendance to work is an essential function of this position
Performs other duties as assigned by Manager/Supervisor.
QUALIFICATIONS:
Required:
Associate's Degree in a related field and/or 1-3 years related experience and/or training.
Basic Mathematical Skills
Basic Computer Skills: Ability to perform basic computer tasks and has the ability to operate common computer programs.
Minimum Professional Proficiency: Ability to speak in a way that allows one to participate effectively in various conversations. Ability to read various types of standard items addressed to general readers.
Intermediate Reasoning: Ability to apply common sense understanding to carry out instructions that may be furnished in written, oral, or diagram form. Ability to deal with problems that involve several concrete variables in standardized situations.
Preferred:
Ability to follow instructions and respond to management direction.
Ability to identify and resolve problems in a timely manner.
Ability to exhibit sound and accurate judgment.
Ability to demonstrate attention to detail.
#LI-RS1
The hiring rate for this position is $ 16.50 - 20.00 /hour plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k).
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future
Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
Auto-ApplyManager, Accounts Payable
PCI Pharma Services job in Rockford, IL
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Position Summary
The Accounts Payable Manager will direct a team of people and be responsible for all accounts payable activities to ensure timely, accurate, and efficient processing of invoices and payments. This is a hands-on position. In this role you will be responsible for maintaining high service standards with vendors and internal departments, supporting team development, and contributing to continuous process improvements. This role will play a pivotal role in developing and enhancing our processes and increasing our utilization of advanced tools. You will report to and work closely with the site Controller, the corporate accounting function, and other stakeholders in the organization.
Key Responsibilities:
Supervise and participate in daily operations of the accounts payable team, ensuring invoices are processed accurately and timely.
Review, Manage, and Monitor invoice workflow and ensure appropriate general ledger coding and approvals.
Review and approve payment batches, ensuring appropriate documentation and coding.
Lead the monthly, quarterly, and year-end close process by preparing and reviewing AP-related reports and reconciliations.
Serve as a point of contact for escalated vendor inquiries and internal department requests.
Maintain vendor records and assist with annual 1099 reporting.
Ensure compliance with internal controls and company policies.
Support external audits and ensure compliance with SOX/internal control requirements.
Provide training, coaching, and daily support to AP staff to encourage growth and performance.
Identify opportunities to streamline AP processes and support automation initiatives.
Assist with monitoring metrics related to invoice processing time, payment accuracy, and vendor satisfaction.
Knowledge, Skills, and Abilities:
Relevant accounting experience in Account Payable in a Manufacturing environment.
Experience with accounting software JDE or similar ERP platform is a plus
Ability to quickly comprehend a complex organizational structure, including the general ledger structure and various financial systems, is essential
Proven ability to leverage current technology to drive process efficiency and improve accuracy
Advanced analytical skills in combination with excellent written and oral communication skills.
Exceptionally well organized, flexible and easily adaptable to changing conditions.
Ability to work under pressure, meet deadlines and manage conflicting priorities.
Advanced and demonstrated proficiency with Excel.
Self-motivated with the ability to multi-task, work independently and with minimal direction.
High energy, high ownership of work product and dedication and commitment to driving results.
“Roll-up-your-sleeves” attitude.
Competencies Required:
Makes confident, fact-based decisions.
Pro-active, looking for new solutions, opportunities and insights.
Approaches problems from different perspectives to suggest and implement solutions.
Forecasts issues pro-actively to prevent potential impacts; both internally and externally.
Facilitates communication between team members to ensure efforts are aligned.
Takes accountability for delivering on commitments; owns mistakes and uses them as opportunities for learning and development.
Ability to solve complex problems.
Adept at using logic and reasoning to work through problems and analyze information.
Pro-active approach and leadership style.
Holds self and others accountable for specific deliverables and continuously raises the bar in terms of quality of work-products delivered.
Minimum Qualifications:
5+ years of experience in a supervisory Accounts Payable role
Bachelor's Degree
The base salary hiring range for this position is ($77,600-$87,300) plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k).
#LI-EK1
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future
Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
Auto-ApplyLogistics Delivery Specialist
PCI Pharma Services job in Rockford, IL
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
2nd Shift:
Monday-Friday
3:00 pm-11:00 pm
Summary of Objective:
The function of this position is to move material to and from the plants and to and from the offsite warehouse utilizing a tractor and trailer CDL (A) and to move and spot trailers in the yards for loading and unloading as required. This includes following all DOT regulations for pre-trip and post-trip inspections, moving materials and trailers as requested, and loading and unloading the trailers with a forklift. This position will also be responsible for completing inventory forms and inventory transactions in JDE, using barcode scanners for inventory control, investigating inventory discrepancies, assist Engineering with equipment movement, responsible for ensuring all logistical cGMP regulations are met and adhered to, and other duties as assigned.
Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The basic duties and responsibilities include the following, but other duties may be assigned.
Fully understand how to operate and safely drive your assigned vehicle.
Drive trucks with a Gross Vehicle Weight (GVW) over 26,000 lbs.
Safely and efficiently handle and unload goods at the destinations.
Communicate with the plant and warehouse to ensure timely movement
Confirm the contents of each load match the move sheets.
Perform inspections of your vehicle before and after each trip.
Always ensure the equipment is kept clean.
Maintain and service vehicles as needed.
Notify managers of any major maintenance or transport issues encountered.
Adhere to company rules and regulations.
Obey all applicable traffic laws and drive according to the weather/road conditions.
Make safety a priority at all times.
Communicate effectively with all levels of the organization.
Complete inventory forms and inventory transactions in JDE.
Use barcode scanners for inventory control.
Investigate inventory discrepancies.
Assist Engineering with equipment movement.
Responsible for ensuring all logistical cGMP regulations are met and adhered to.
Maintain compliance with warehouse records and log books.
Perform forklift battery maintenance functions by checking water levels, charging batteries, and changing batteries in the forklift trucks.
This position may require overtime and/or weekend work.
Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, and rules.
Attendance at work is an essential function of this position.
Performs other duties as assigned by Manager/Supervisor.
Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Required:
Skills testing requirements met at the approved grade level for the position.
Basic Mathematical Skills
Basic Computer Skills: Ability to perform basic computer tasks and operate common computer programs.
Limited Working Proficiency: The ability to satisfy routine social demands and limited work requirements. The ability to read simple prose, in a form equivalent to typescript or printing, on subjects within a familiar context.
Basic Reasoning: Ability to apply common sense understanding to carry out uninvolved written or oral instructions. Ability to deal with problems that involve only a few concrete variables in standardized situations.
Valid Class A driver's license required
Clean driving record with no moving violations
Skilled at driving large vehicles
Comfortable maneuvering and parking a tractor-trailer
Alert, focused, and detail-oriented
Physically and mentally fit
Ability to lift up to 50 lbs. at a time
Able to operate an electric lift, hand trucks, pallet jacks, etc.
Disciplined, dependable, and resourceful
Preferred:
2+ years of proven experience with tractor-trailer driving preferred
Ability to display excellent time management skills.
Ability to display a willingness to make decisions.
Ability to demonstrate attention to detail.
Ability to identify and resolve problems promptly.
For candidates in Illinois: The hiring rate for this position is $19.96 to $22.46 hourly, plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), a flexible spending account, and a 401(k).
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future
Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
Auto-ApplyContinuous Improvement Specialist
PCI Pharma Services job in Rockford, IL
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. **We are PCI.** Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Position Title: Continuous Improvement Specialist
Shift: First Shift
Manages the Operational support system to ensure data is being collected for OEE 1 and OEE2, which is used to make many real-time decisions and long-term decisions regarding the true root cause of downtime and will support the VS Manager with data and ideas for improvement. Lead and or support Kaizen events for the Rockford site and is the resident Lean and Kaizen expert.
**Essential Duties and Responsibilities:**
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following, but other duties may be assigned.
+ Is the site subject matter expert with all aspects of the Operational management system, Factory MES. This includes but not limited to: being the system administrator, managing the improvement opportunities with the system, managing the software updating of the system, define the system KPI's and partner with engineering on all program adjustments and changes, managing the change process with system as the production lines change and expand, being the site expert on report development and data analysis, and be the site point of contact with the vendor for the system needs.
+ Manages and drives a culture of Kaizen through the current T-card process and by participating and leading onsite and offsite Kaizen events. This will include being a member of Kaizen events, planning and executing Kaizen events, managing the Kaizen tasks list, scheduling Kaizen meetings, following up with Kaizen leaders, managing the Kaizen board, but most importantly, ensuring the site Kaizen metrics are visible and sustained.
+ Ensures all new best practices are captured in standard work and partners with the training department in the development of specific training plans. Following the TWI (Training within Industry) format and principles is imperative to knowing and learning data analysis software tools like SQL, Power BI, and Tableau. This person will need to develop and distribute all operational data to department owners and have the ability to adjust and improve the data format, and the ability to cross-reference data from department to department.
+ Is an expert in the development and routing of all operational standard work. Execution of training others on how to develop and route standard work is imperative.
+ Establishes criteria and well-articulated implementation plans like A3s, Smart Sheets, realistically defined specific charters, which will include timelines and action lists.
+ Systematically identify losses within the value stream. These can be losses/wastes of any resource, but the typical focus is on equipment, work process, inventory, materials, design, production throughput, time, or energy.
+ Support and monitor the ongoing implementation of lean activities, including but not limited to standard work implementation, line balancing, waste removal, SMED, 5S, Process Improvements, and Gemba Walks
+ Provide status updates to both personnel and management through effective communication.
+ Interact with internal and external customers specific to line activities for lean initiatives.
+ Promote benchmarking and best practice sharing with other areas/departments within the plant or sister plants. Establish best practice standards to be used as goals for lean initiatives.
+ This position may require overtime and/or weekend work.
+ Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, and rules.
+ Attendance at work is an essential function of this position.
+ Performs other duties as assigned by the Manager/Supervisor.
**Qualifications:**
The requirements listed below are representative of the knowledge, skills, and/or abilities required for the stated position. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
**Required:**
+ Bachelor's Degree in a related field and/or 1-3 years related experience and/or training.
+ College-Level Mathematical Skills
+ Intermediate Computer Skills: Ability to perform more complex computer tasks and have knowledge of various computer programs.
+ Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
+ Intermediate Reasoning: Ability to apply common sense understanding to carry out instructions that may be furnished in written, oral, or diagram form. Ability to deal with problems that involve several concrete variables in standardized situations.
**Preferred:**
+ Ability to effectively present information to various people as the job requires.
+ Ability to identify and resolve problems promptly.
+ Ability to hold oneself professionally.
+ Ability to display excellent time management skills.
The hiring rate for this position is $62,960-$70,830 plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k).
\#LI-KH1
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future (*****************
**Equal Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
Quality Control Coordinator
PCI Pharma Services job in Rockford, IL
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. **We are PCI.** Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
**Position Title: Quality Control Coordinator**
**Location: Assembly Drive, Rockford, IL 61109**
**Shift: 1st Shift**
**SUMMARY**
The Quality Coordinator assists with coordinating quality activities to ensure that goals and objectives of the team are accomplished within prescribed time frames. Helps drive project success to provide PCI a competitive advantage in long-term quality customer management.
**Essential Duties and Responsibilities:**
+ Prepares and distributes required documentation for requested production work orders.
+ Perform documentation review of completed orders to ensure compliance with cGMP's and customer requirements.
+ Reviews and interprets customer standards, procedures, and specifications for dissemination relative to batch records, forms and material specifications.
+ Prepares customer required samples for shipment according to approved shipping instructions.
+ Prepares and submits batch records, accountability reports and necessary documentation to customers to facilitate product release.
+ Organize internal and customer approval of batch records and specs.
+ Perform record reviews of both completed and in-process orders to ensure compliance with cGMP's and customer requirements.
+ Perform Line Clearance inspections of equipment and production suites.
+ Help identify, communicate, track and resolve document related issues with other departments and customers.
+ Function as one of the customer points for comments or questions pertaining to batch records.
+ Initiating supplier non-conformance reports and effectuates material control.
+ Reviews and integrates planned deviation requests into batch records when needed.
+ Adherence to PCI and cGMP policies, procedures, rules and regulations.
+ Attendance to work is an essential function of this job.
+ May perform label creation duties including generating computerized labels.
+ May perform duties of Quality Auditor as assigned by Supervisor/Manager.
+ Other duties as assigned by Supervisor/Manager.
+ Shift is Monday through Friday 8:00 am to 5:00 pm.
**Qualifications:**
**Required:**
+ High School Diploma or GED
+ 1-3 years related experience and/or training.
+ Basic Mathematical Skills
+ Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs.
+ Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
+ Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables.
+ High Standard of Report Writing
**Preferred:**
+ Ability to follow instructions and respond to management direction.
+ Ability to work independently and/or part of a team.
+ Ability to display excellent time management skills.
+ Ability to demonstrate attention to detail.
+ A college degree with a concentration in a scientific discipline is preferred.
+ The candidate must be able to demonstrate basic proficiency with computers, business software (e.g. MS Office) and technical software (e.g. Master Control). Ability to create, use and interpret scientific tables, charts, and graphs. Any Lean Six Sigma or process improvement training is a plus.
For Illinois residents: the hiring rate for this position is $18.15 to $20.42 hourly plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k).
_Equal Opportunity_ _Employer/Vet/Disabled_
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future (*****************
**Equal Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
IC&V Technician 1 (NMSR)
PCI Pharma Services job in Rockford, IL
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. **We are PCI.** Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
**Location: New Milford School Rd.**
**Shift: 1st (10 hours)**
**Summary of Objective:**
Sets up, installs, and maintains electrical control systems including, but not limited to, Servo systems (for example, Allen Bradley, Emerson, Elau), OITs (for example, Allen Bradley, Panelview, Panelview Plus, RSView), PLCs (Allen Bradley SLC, Compact, Control Logix), loop controllers, sensors, ID readers, vision systems, VF and DC drives, labelers, lasers, thermal and inkjet printers, and robotics by checking power and wiring; performing power up procedures; firing laser and ensuring code is printing properly; installing and incorporating modules into machines; and servicing equipment and correct any identified issues.
**Essential Duties and Responsibilities:** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.
+ AC/DC Control Circuits: Knowledge of electrical devices in AC/DC control circuits (e.g., switches, relays, indicators, motor starters, overloads, contactors, fuses). This includes knowledge of types of devices, limits, and functions.
+ AutoCAD: The ability to draft equipment drawings and diagrams for design purposes using AutoCAD.
+ Calibration Procedures and Certifications: Knowledge of the equipment used to rest machine calibrations and the parameters necessary to receive calibration certifications.
+ Drawings and Diagrams: The ability to read, interpret, and use the information presented in drawings, diagrams, schematics, and blueprints to determine appropriate activities, tools, and next steps in the production process.
+ Electrical Component Diagnostics: Knowledge of and the ability to troubleshoot and diagnose electrical defects at the component level (e.g., transformers, relays, controllers).
+ Electrical Knowledge: Knowledge of the basic principles of electricity, wiring, conduit and controls, motors and breakers, and high-low voltage systems.
+ Electrical Systems: Knowledge of 3-phase electrical systems, including components, repair processes, and installation procedures.
+ Hand-eye Coordination: The ability to coordinate one's eyes with one's fingers, wrists, or arms to move, carry, or manipulate objects or to perform other job-related tasks.
+ Hand Tools: Knowledge of and the ability to use a variety of basic hand tools (e.g. wrenches, hammers, screw drivers, knives, scissors, and box cutters).
+ Pneumatic Components and Diagrams: Knowledge of pneumatic systems and diagrams. This includes knowledge of functions, components, and safety procedures.
+ Inspection Techniques and Tools: Knowledge of and the ability to apply inspection techniques (e.g. formalized inspection standards, inspection instructions, batch record instructions, best practices), and to use inspection tools efficiently.
+ Lockout/Tagout (LOTO) Procedures: Knowledge of the processes and procedures to lock out equipment while cleaning, repairing, or servicing.
+ Machine/Equipment Knowledge: Knowledge of mechanical components, connections, and interdependencies. This includes knowledge of basic machine operations, gears, and drive shafts, and basic electrical wiring.
+ Machine Maintenance: The ability to perform routine and predictive maintenance on equipment and machines, and determine what maintenance is needed.
+ Manual Dexterity: The ability to quickly move your hands, your hands together with your arm, or your two hands to grasp, manipulate, or assemble objects.
+ Material Handling Equipment: Knowledge of and the ability to use material handling equipment, including forklifts, aerial lifts, and pallet jacks.
+ Measuring Devices: The ability to read and use micrometers, measuring tools, gauges, indicators and calibration stickers.
+ Mechanical Aptitude: General knowledge of machines and equipment functionality, including how and which tools could be used on such equipment machines. This includes the ability to learn new systems quickly and understand how parts relate and how they impact system functionality.
+ Packaging Techniques: Knowledge of packing materials, systems, and machinery. This includes the ability to use packaging and labeling equipment to package products in accordance with company guidelines.
+ PLC Programming: Knowledge of and the ability to read and write programmable logic code for PLCs. This includes knowledge of Allen Bradley and Automation Direct programming, and other control systems.
+ Power Tools: The ability to properly and safely operate, maintain, repair, clean, and store power tools and equipment (e.g., chop-saw, hand drills, table saws, sanders).
+ Preventative Maintenance: The ability to identify equipment maintenance needs by using PM Work Orders. This includes the ability to communicate these needs to the appropriate persons.
+ Production Processes: Basic knowledge and development of plant production processes and layouts, which includes cross-departmental coordination, communication, and planning within our area of responsibility.
+ Servo Drives: The ability to commission, program, and diagnose motion systems.
+ Vision-Systems: Knowledge of machine vision systems, including the ability of program code-reading systems.
+ Visual Acuity: The ability to see details (e.g., letters, numbers, codes, color, symbols, marks, labels, signs) clearly, to accomplish work tasks in a safe and efficient manner.
+ This position may require overtime and/or weekend work.
+ Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, and rules.
+ Attendance to work is an essential function of this position
+ Performs other duties as assigned by Manager/Supervisor.
**Qualifications:** The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
**Required:**
+ Skills testing requirements met at the approved grade level for the position.
+ Associate's Degree in a related field and/or 1-3 years related experience and/or training.
+ Basic Mathematical Skills
+ Intermediate Computer Skills: Ability to perform more complex computer tasks and knowledge of various computer programs.
+ Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
+ Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables.
+ High standard of report writing.
**Preferred:**
+ Ability to effectively present information to various people as the job requires.
+ Ability to follow instructions and respond to management direction.
+ Ability to identify and resolve problems in a timely manner.
+ Ability to work independently and/or as part of a team.
+ Ability to display excellent time management skills.
+ Ability to display a willingness to make decisions.
+ Ability to display original thinking and creativity.
+ Ability to hold oneself in a professional manner.
+ Ability to adapt to changing work environments.
+ Ability to set and achieve challenging goals.
+ Ability to exhibit sound and accurate judgment.
+ Ability to demonstrate attention to detail.
**Other titles known: Mechatronics & Robotics Technician** , **Controls Engineer, Controls Technician, Electronic Technician, Industrial Electrician, PLC Programmer, Electrical Controls Technician**
The hiring rate for this position is $24.58-$27.65 hourly plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k).
\#LI-SW1
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future (*****************
**Equal Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
Security Specialist
PCI Pharma Services job in Rockford, IL
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. **We are PCI.** Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Position Title: Security Specialist
Location: Assembly Drive, Rockford, IL 61109
Department: Security
Shift: 1st Shift
Reporting To: Supervisor, Security
Responsible For (Staff): None
**Job Summary**
PCI is seeking a Security Specialist who will play a crucial role in safeguarding our facilities, data, and intellectual property. The successful candidate will be responsible for conducting thorough risk assessments to identify potential security threats and vulnerabilities, developing and implementing robust security protocols to protect against unauthorized access, data breaches, and other security incidents, and utilizing advanced monitoring and surveillance systems to ensure the safety and security of our premises and assets. Additionally, the Security Specialist will lead incident response efforts, including investigations, documentation, and resolution of security breaches, ensure compliance with industry standards, regulations, and best practices related to security and data protection. Provide training and awareness programs to employees on security policies and procedures. The ideal candidate will have a strong background in security management, excellent analytical skills, and the ability to work collaboratively with cross-functional teams. Experience in the pharmaceutical or biotechnology industry is a plus.
**Essential Duties and Responsibilities:**
+ Ensure the protection and safeguarding of company assets, personnel, visitors, and sensitive materials through proactive security measures and situational awareness.
+ Conduct thorough investigations into security incidents, breaches, and other matters requiring detailed analysis.
+ Collect and document statements from witnesses, victims, and suspects in a clear and concise manner.
+ Perform comprehensive foot patrols, verifying the integrity of security measures and submitting thorough documentation of observations.
+ Monitor and assess activity in parking areas, employee access points, and high-traffic zones, maintaining vigilance during shift changes and peak operational hours.
+ Conduct scheduled and random security inspections, documenting findings in detailed security reports and escalating concerns as necessary.
+ Enforce security protocols by issuing citations for violations in accordance with established policies and procedures.
+ Respond promptly to environmental, fire, and security alarms, following the established call-out matrix and emergency response protocols.
+ Monitor and manage surveillance systems, identifying and reporting suspicious behavior or security breaches.
+ Maintain and manage access control systems, including issuing ID badges and access cards to employees, contractors, and vendors, ensuring compliance with badge policies.
+ Serve as a key member of the Medical Emergency Response Team (MERT), providing support during medical incidents.
+ Activate and deactivate alarm systems as required for operational security.
+ Secure facility entrances and exits by locking/unlocking designated access points per schedule.
+ Assist in the development and revision of security-related policies and standard operating procedures.
+ Maintain accurate inspection logs and incident records, advising management on deficiencies and recommending corrective actions.
+ Prepare and process personnel security clearance requests and maintain associated documentation.
+ Provide professional assistance to employees, visitors, and vendors while upholding departmental protocols.
+ Under the direction of the Director of Security or Security Manager, mentor, train, and supervise a team of approximately twelve contract security officers, leveraging prior military/law enforcement leadership experience. · Flexibility to work overtime and weekends as required by operational needs. · Maintain reliable attendance and punctuality as a critical function of the role. · Maintain strict adherence to all PCI, cGMP, and GCP policies, procedures, and regulatory requirements.
**Qualifications:**
**Required:**
+ Associate's degree in a related field preferred and/or 3-5 years of relevant experience in security operations, investigations, or a related field.
+ Previous experience in law enforcement, corrections, or military service.
+ A valid driver's license is required.
+ Strong investigative skills with the ability to analyze complex situations.
+ Excellent communication skills, both written and verbal.
+ Proficiency in conducting interviews and collecting statements.
+ Experience in providing de-escalation training.
+ Basic Mathematical Skills · Intermediate Computer Skills: Ability to perform more complex computer tasks and have knowledge of various computer programs. · Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
+ High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms.
+ Driver's License Preferred
+ Knowledge of security systems and technologies. Good working knowledge of security operations, safety practices in a business environment and enforcement procedures. · Familiarity with legal and regulatory requirements related to security. Ability to effectively present information to various people as the job requires. Ability to identify and resolve problems in a timely manner. Ability to hold oneself in a professional manner. Ability to demonstrate attention to detail.
+ Military or police background
+ Must be able to perform work both inside and outside the property with exposure to inclement weather and unpredictable crisis situations.
**For candidates in Illinois:** The hiring rate for this position is $22.15 to $25.00 hourly plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), a flexible spending account, and 401(k).
\#LI-KH1
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future (*****************
**Equal Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
Continuous Improvement Manager
PCI Pharma Services job in Rockford, IL
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. **We are PCI.** Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
**Main purpose of role:**
The purpose of this role is to transform sites and establish a sustainable Lean culture by driving the elimination of waste and enabling the flow of value to the internal and external customer.
The CI Manager will demonstrate accountability for the deployment of Lean Thinking across the site, ensuring alignment with the Site Strategy and Global Operational Excellence. Manage a team of 5-8 CI professionals to drive improvement over 1MM square feet of a Pharma Packaging and Device Assembly facility that runs 24 /7.
**Main responsibilities:**
+ Create, in conjunction with the Global OPEX Director and Site GM, the lean vision for the site and facilitate the implementation of the Lean Maturity Index to establish an Operational Centre of excellence.
+ Define weekly goals for the CI team that align with the site's yearly CI goals. Develop and use a project hopper that organizes site priority, gives feedback to the customer, and tracks CI savings.
+ Facilitate and coach CI Engineers to use tools like A3, cross-functional Kaizen events, lean training, KATA events, and other CI tools to drive best practice in process improvement.
+ Lead Business Critical Improvement Projects and the associated teams, as directed by the General Manager and SLT.
+ Represent the Site by engaging with the Director of Global Operational Excellence, ensuring global standards are deployed (Lean Maturity Index), site best practice shared, and results communicated.
+ Use margin and cost-based analysis to identify opportunities to implement improvement activities to increase profitability, setting yearly savings goals for each CI team member.
+ Maintain and report Site cost-saving data in support of the Business Cost Reduction Targets.
+ Lead, mentor, and train the Site Team to raise Lean Awareness, develop the Lean Approach and build in Lean Capability across all functions.
+ Be part of the Site Senior Management team, supporting alignment to site strategy across all departments, challenging non-value adding activity and facilitating Lean Leadership.
**Work Experience and Skills Required**
+ Experience of leading teams in the Pharmaceutical and/or Medical Device industry (other highly regulated and quality-driven industries may be considered)
+ Able to demonstrate application of continuous improvement tools and techniques (Kaizen, TPM, SMED, RCA, 5S) to deliver positive outcomes.
+ Strong interpersonal skills must be driven to develop relationships with Site Leaders, SMEs, and Direct Labor Work Force.
+ Dynamic and ambitious professional with a proven delivery record.
+ Strong team player able to demonstrate an ability to lead and facilitate informal and formal teams in the development and delivery of improvement solutions.
+ Able to work across the operational organizational environment and is driven to find solutions to opportunities.
+ Must be able to work under pressure and coordinate multiple activities concurrently.
+ Hands-on approach to problem solving and mindset, organized and methodical.
+ Demonstrated ability to extract critical information to enable effective and appropriate decision making.
+ Strong understanding of stakeholder management tools to ensure engagement in change at all levels.
+ Willing to learn and develop skills and knowledge.
+ People Management.
+ Experience of managing finances and tracking of cost savings.
**Qualifications:**
+ Lean Black Belt 'Certified' with tenure in the role using this methodology.
+ Leadership training and experience.
+ Education, preferably a degree, in Process Engineering, or other CI related degrees.
+ Quality Engineering education and experience.
**Regulatory/Industry Responsibilities:**
**Preferred:**
+ Quality Engineering education and experience.
The hiring rate for this position is $97,280-$109,440 plus eligibility 10% MPB for an annual performance bonus. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), a flexible spending account, and a 401(k) plan.
\#LI-SW1
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future (*****************
**Equal Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
Accounting Controller
PCI Pharma Services job in Rockford, IL
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. **We are PCI.** Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Position Summary
This position will direct staff and manage all accounting activities to ensure compliance with generally accepted accounting principles, corporate policies, and external audits. In this position you will be responsible for all accounting functions to include but not limited to payroll, accounts payable, accounts receivable, and the monthly closing and preparation of reports in support of all financial statements. You will report to and work closely with the Executive Finance Director ("EFD"), the corporate accounting function and other stakeholders in the organization. This position requires strategic financial leadership, operational partnership, and compliance oversight in a dynamic, profitable, and growth-oriented environment.
**Key Responsibilities:**
+ You will be responsible for all aspects of accounting (payroll, accounts payable, accounts receivable, billing, general ledger, fixed assets, audit, etc.).
+ Direct and supervise a team of people and proactively manage and coach the team providing employee development opportunities.
+ Manage and deliver timely monthly financial close process, including preparing journal entries, ensuring all costs incurred are properly recorded, perform account balance reconciliations and report preparation.
+ Oversee variance analysis and review expenses by financial statement line item for reasonability, investigate unusual amounts, make any corrections as necessary, and determine root cause and solutions.
+ Interact at all levels and with budget owners or other stakeholders to produce timely, efficient and accurate month-end close and all internal management and financial reporting incl. lease accounting.
+ Participate in the ongoing development & establishment of accounting policies and procedures and operational strategies including the review and implementation of process and system changes.
+ Drive continuous process improvements leveraging digital technology and support the development and enhancement of the ERP platform (JDE) to ensure systems integrity, financial effectiveness and controls.
+ Collaborate with external auditors to ensure successful audit results and compliance.
+ Define and maintain department KPI's.
+ Ensure compliance with internal control policies.
+ Assist with compilation of information for preparation of tax returns.
+ Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
+ Performs other duties and corporate finance projects as assigned by Manager.
**Knowledge, Skills and Abilities:**
+ Relevant accounting experience in Manufacturing and/or Supply Chain.
+ Apply GAAP accounting standards related to revenue recognition, lease accounting and asset capitalization.
+ Experience with accounting software JDE or similar ERP platform is a plus.
+ Ability to quickly comprehend a complex organizational structure, including the general ledger structure and various financial systems, is essential.
+ Proven ability to leverage current technology to drive process efficiency and improve accuracy
+ Advanced analytical skills in combination with excellent written and oral communication skills.
+ Exceptionally well organized, flexible and easily adaptable to changing conditions.
+ Ability to work under pressure, meet deadlines and manage conflicting priorities.
+ Advanced and demonstrated proficiency with Excel.
+ Self-motivated with the ability to multi-task, work independently and with minimal direction.
+ High energy, high ownership of work products and dedication and commitment to driving results.
+ Work on-site in Rockford, IL.
+ "Roll-up-your-sleeves" attitude.
**Competencies Required:**
+ Confident, fact-based decision maker.
+ Pro-active, looking for new solutions, opportunities and insights.
+ Approaches problems from different perspectives to suggest and implement solutions.
+ Forecast issues pro-actively to prevent potential impacts; both internally and externally.
+ Facilitates communication between team members to ensure efforts are aligned.
+ Takes accountability for delivering on commitments; owns mistakes and uses them as opportunities for learning and development.
+ Ability to solve complex problems.
+ Adept at using logic and reasoning to work through problems and analyze information.
+ Pro-active approach and leadership style.
+ Holds self and others accountable for specific deliverables and continuously raises the bar in terms of quality of work-product delivered.
**Minimum Qualifications:**
+ CPA (CA, CMA or CGA) designation with 10+ years related work experience.
+ Manufacturing experience required.
+ Pharmaceutical Industry experience preferred.
The base salary hiring range for this position is ($122,000-$150,000) plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k).
\#LI-EK1
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future (*****************
**Equal Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
Packaging Development Intern
PCI Pharma Services job in Rockford, IL
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. **We are PCI.** Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Job Title: Package Development Intern
Department/Group: **Design**
Location: **Rockford**
Summary of Objective:
The Package Development Intern CO/OP supports the Package Design department in the development and creation of new package designs for PCI clients. Working collaboratively with Package and Graphic Designers, the candidate performs various tasks.
**Essential Duties and Responsibilities:** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.
Responsible for packaging design and concept generation, specification management, sample creation, and performance testing. Support the CAD based structural design. Support the physical creation of functional prototype packaging. Support optimization of existing packaging. May support Project Management and Engineering activities as required. This position may require overtime and/or weekend work. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules. Attendance to work is an essential function of this position Performs other duties as assigned by Manager/Supervisor.
**Special Demands:** The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions
+ **Stationary Position:** Under a 1/4 of the day.
+ **Move, Traverse:** 3/4 of the day and up.
+ **Operate, activate, use, prepare, inspect, or place:** 3/4 of the day and up.
+ **Install, place, adjust, apply, measure, use, or signal:** 3/4 of the day and up.
+ **Ascend/Descend or Work Atop:** Up to 1/4 of the day.
+ **Position self (to) or Move (about or to):** Up to 1/4 of the day.
+ **Communicate or exchange information:** From 1/2 to 3/4 of the day.
+ **Detect, distinguish, or determine:** Up to 1/4 of the day.
On an average day, the individual can expect to move and/or transport up to 25 pounds
less than 1/4 of the day.
This position may have the following special vision requirements.
+ Close Vision ☒ Distance Vision ☒ Color Vision ☒ Peripheral Vision ☒ Depth Perception
+ Ability to focus ☐ No Special Vision Requirements
**Work Environment:** The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The following are some environmental conditions that one may be exposed to on a daily basis and for various lengths of time.
+ Work is primarily performed at a desk and/or in an office environment. for up to 1/4 of the day.
+ Work near moving mechanical parts for 1/4 to 1/2 of the day.
The noise level in the work environment is typically, moderate.
**Qualifications:** The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
**Required:**
+ Participate in a Package Engineering Bachelor's Program
+ College Level Mathematical Skills
+ Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs.
+ Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
+ Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables.
+ Familiarity and knowledge of paperboard, corrugated, plastics and flexible films.
**Preferred:**
+ Ability to follow instructions and respond to management direction.
+ Completion of Medical/Pharmaceutical Packaging course
+ Completion of introductory Packaging courses
+ Participate in Package Engineering Bachelors Program
+ Knowledge of CAD, TOPS, Adobe Illustrator Design software; Internet Explorer; Microsoft Office Suite
_The hiring rate for this position is $25.00/hour plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k)._
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future (*****************
**Equal Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
Tool and Die Machinist
PCI Pharma Services job in Rockford, IL
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. **We are PCI.** Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
**Location:** Assembly Drive, Rockford, IL 61109
**Shift:** 1st Shift
**S** **u** **m** **m** **a** **ry** **o** **f** **O** **bj** **e** **c** **t** **i** **v** **e:**
This position is responsible for the fabrication, modification, repair, and maintenance of precision tools, dies, jigs, fixtures, and machine parts using manual and CNC machinery. Must have the ability to program CNC with offline software. The ideal candidate will have strong experience in machining and toolmaking, and be able to read blueprints, work with tight tolerances and grinding parts as necessary. High understanding of metallurgy. Reverse engineer parts in real time. Manages work order completions, spreadsheets and schedules.
**Ess** **e** **nti** **a** **l Duties** **a** **nd R** **e** **s** **p** **o** **n** **s** **ib** **i** **liti** **e** **s** **:** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.
+ **Program and operate** manual and CNC machines (mills, lathes. grinders, & etc)
+ Read, interpret engineering drawings, blueprints , and CAD designs.
+ Build, repair and maintain stamping dies, molds, fixtures, and custom tools.
+ Knowledge of how different metals react to various temperatures, pressures, and forces, (metallurgy).
+ Inspect and measure finished parts to ensure they meet specifications.
+ The ability to perform routine and predictive maintenance on equipment and machines.
+ Must work under tight time lines with multiple priorities.
+ Troubleshoot and make adjustments to dies and tooling for optimal performance.
+ Work closely with engineers, production staff, maintenance team,
+ Ensure safety protocols and company procedures are followed
+ The ability and willingness to take ownership of work activities and ensure that they are completed accurately, efficiently, and in a timely manner.
+ The ability to work across organizational and functional boundaries to achieve company goals. This includes the ability to build and maintain strong relationships with cross-functional teams and managers
+ The ability and willingness to generate new ideas to improve work efficiencies, productivity, and customer service.
+ The ability to perform general machining activities using mills, lathes, drill press, grinders andother machine shop tools.
+ The ability to read and use micrometers, measuring tools, gauges, indicators and calibration stickers.
+ Knowledge of CNC programming/machining, including the ability to read, understand, and edit basic programs
+ General knowledge of machines and equipment functionality, including how and which tools could be used on such equipment machines. This includes the ability to learn new systems quickly, understand how parts relate and how they impact system functionality.
+ This position may require overtime and/or weekend work.
+ Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
+ Attendance to work is an essential function of this position
+ Provide mechanical floor support on installation(s) and project(s) as required.
+ Performs other duties as assigned by Manager/Supervisor.
+ Must be able to use Excel and Microsoft Office programs.
**Q** **u** **a** **lific** **at** **i** **o** **n** **s** **:** The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
**Required:**
+ High school diploma or GED, technical or trade school certification preferred
+ 5+ years of experience as a machinist or tool and die maker
+ Proficient in reading mechanical drawings and GD&T
+ Experience with CNC and manual tools
+ Familiarity with precision measuring instruments (micrometers, calipers, indicators)
+ Strong attention to detail
+ Ability to lift 50 lbs and stand for extended periods
**Pr** **ef** **e** **r** **r** **e** **d:**
+ Apprenticeship or journeyman certification in tool and die or machining
+ Experience in a high-volume manufacturing environment
+ **Knowledge of CAD/CAM software (e.g.,FutureCam, MasterCam, SolidWorks)**
+ Ability to work independently and/or part of a team.
+ Ability to display excellent time management skills.
+ Ability to adapt to changing work environments. Knowledge of CNC programming/machining, including the ability to read, understand, and edit basic programs..
+ The ability to read, interpret and use the information presented in drawings, diagrams, schematics and blueprints to determine appropriate activities, tools and next steps in the production process.
_The hiring range for this position is $30.26 - $34.05/hour plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k)._
_\#_ LI-MC1
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future (*****************
**Equal Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
Project Engineer- Drug Delivery
PCI Pharma Services job in Rockford, IL
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Position Summary
As a Project Engineer - Drug Delivery, you'll play a hands-on, critical role in the design, development, and execution of pharmaceutical packaging and assembly projects. Working closely with engineering, quality, and validation teams, you'll help deliver high-impact solutions that directly affect patient outcomes around the world.
This role supports key product introductions - including high-speed auto-injector lines for diabetes management-giving you the opportunity to work on cutting-edge drug delivery technology. You'll collaborate with both internal stakeholders and external customers, ensuring projects are delivered on time, on budget, and in compliance with all regulatory standards.
This is more than a role-it's a career path. Our Project Engineers have advanced to senior-level roles, including Engineering Manager, based on performance, innovation, and leadership.
Key Responsibilities
Project Execution & Engineering Design
Design and implement line layouts for pharmaceutical assembly and packaging processes.
Develop and procure tooling for new and existing packaging equipment to support clinical and commercial production.
Support Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) for packaging equipment.
Drive equipment commissioning, qualification, and troubleshooting activities.
Author and maintain engineering documentation including URS, SOPs, and validation support records.
Technical Leadership & Innovation
Apply engineering best practices to optimize process performance, safety, and product quality.
Identify and resolve process inefficiencies with a focus on improving Overall Equipment Effectiveness (OEE).
Participate in risk assessments and problem-solving investigations (e.g., CAPAs, root cause analysis).
Lead line improvement initiatives using Lean Six Sigma and operational excellence tools.
Client & Cross-Functional Collaboration
Serve as a technical liaison with customers, sales, vendors, and internal stakeholders.
Collaborate with Quality, Validation, Operations, and Business Development to support new product introductions and line extensions.
Represent Engineering in weekly client meetings, cross-functional project updates, and design reviews.
Support material selection and supplier communication to ensure packaging compatibility and performance.
Compliance & Quality Support
Ensure strict adherence to PCI's cGMP, GCP, and internal regulatory policies and procedures.
Provide validation support through IQ/OQ/PQ processes.
Review and approve batch records and technical documentation for accuracy and completeness.
Qualifications
Required:
Bachelor's degree in Mechanical, Biomedical, Chemical, or related Engineering discipline.
1-5 years of experience in a project or process engineering role, ideally within the pharmaceutical or medical device industry.
SolidWorks proficiency (required); AutoCAD experience a plus.
Strong problem-solving and analytical skills with demonstrated attention to detail.
Full professional fluency in English (written and verbal).
Intermediate to advanced proficiency in Microsoft Office (Excel, Project, PowerPoint, Visio).
College-level mathematical and technical reasoning skills.
Preferred:
Experience in medical device or pharmaceutical packaging equipment (e.g., blister, bottling, pouching, carting).
Familiarity with cGMP regulations and cleanroom manufacturing environments.
Knowledge of Design Controls (CFR 820.30 / ISO 13485) and Risk Management (ISO 14971).
Lean Six Sigma Green Belt certification or similar process improvement training.
Demonstrated ability to collaborate across departments and communicate with external clients.
Ability and willingness to travel based on project needs.
The base salary hiring range for this position is ($77,600 - $92,150) plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k).
#LI-SW1
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future
Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
Auto-ApplyCommercial Associate Project Manager (Onsite Required)
PCI Pharma Services job in Rockford, IL
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. **We are PCI.** Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
**Commercial Associate Project Manager**
Assists with designated execution of customer projects and ongoing order fulfillment to ensure that objectives are accomplished within prescribed time frame and budget while adhering to applicable pharmaceutical regulations. Supports maintaining exceptional client satisfaction and superior business performance metrics.
**Essential Duties and Responsibilities:**
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.
+ Create and maintain the customer specific production schedule for both long-term forecast and short-term production demands; follow up on the workflow through each step to maintain schedule integrity and communication. Communicate any On-Time Delivery risks.
+ Ensure accurate forecasts are in place for monthly Material Requirements Planning runs.
+ Understand and interpret application of purchasing authorization from the supply agreement; Place purchase order requisitions with procurement and work with them to expedite, delay or cancel if necessary; ensure on-time delivery and communicate any issues with on-time delivery. Support fulfillment and application of Material Requirements Planning tools in ERP system though forecast and order management.
+ Maintain an understanding of the document creation process which includes, but is not limited to, the following: Lot/Expiration form creation, material receipt/release, batch record preparation and ERP work order creation.
+ Track On-Time Delivery and document creation metrics for the appropriate business units
+ Manage and monitor purchase order status' within the PCI-Rockford organization to ensure On-Time Delivery metrics are met
+ Work with the customer to ensure correct components and artwork changes; communicate price variances with management.
+ Review and approve documentation including specifications and batch records, as required.
+ Create bill of materials, component item number and ensure overall data entry accuracy and management.
+ Monitor and facilitate timely Releases of finished goods. Assist in the preparation of shipment documents.
+ Assist with disposition of Nonconforming materials and Component Variance Notifications.
+ Order and ensure shipper labels and print mats are ready for maintenance and production requirements
+ Ensure obsolete materials are dispositioned and invoiced after a component revision or the end of a project. Responsible for ensuring the destruction of obsolete materials & expired materials as well as providing the Certificate of Destruction to the customer (as required).
+ Work with Incoming Quality Department to ensure timely release of components and bulk.
+ Allocate and manage lot specific materials to the Work Order.
+ Maintain optimal component inventory level for customer owned inventory. Provide continuous support to Project Manager and team for day-to-day internal problem solving and trouble shooting.
+ Training and onboarding for new employees within same role, as requested. This position may require overtime and/or weekend work.
+ Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
+ Attendance to work is an essential function of this position.
+ Performs other duties as assigned by Manager/Supervisor.
**Qualifications:**
The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
**Required:**
+ Associate's Degree in a related field and/or 1-3 years related experience and/or training.
+ College Level Mathematical Skills
+ Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs.
+ Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
+ High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms.
**Preferred:**
+ Able to set and achieve challenging goals.
+ Ability to adapt to a changing work environment.
+ Ability to display excellent time management skills.
+ Ability to identify and resolve problems in a timely manner.
**For Illinois residents** : The hiring rate for this position is $56,720-$64,000 plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k).
**\#LI-JM1**
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future (*****************
**Equal Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
Project Cost Estimator
PCI Pharma Services job in Rockford, IL
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Project Cost Estimator
The ability of the estimation team and larger sales organization to provide business proposals in a timely manner is critical to growing the business. The timeliness and professionalism of our proposals provides our customers with their first impression of PCI and our processes. This role will allow us to have a focused and streamlined estimation process for supporting the sales team proposal needs and grow the business.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Work with the sales team, business unit managers, and customers to understand the scope of the business opportunity we are reviewing.
Work with the Cost Estimating management and Sales management to determine the strategic approach to an opportunity.
Work with Package Design to draft package dimensions PCI proposes for the project.
Work with Purchasing and vendors to determine adequate material specifications and understand material costs for each packaging opportunity.
Work with the Cost Estimating Manager and the Sr. VP of Sales to appropriately price the piece of business.
Work with the sales team to generate the format of the proposal.
Conduct and lead open conversations with Design and Engineering and propose the best process for the project.
Determine the best piece of equipment to run the project and host strategy meetings with engineering to determine process and equipment, when necessary.
Determine the staffing, speeds, and efficiencies for each requested opportunity.
Maintain metrics aligned with senior leaderships expectations.
This position may require overtime and/or weekend work.
Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, and rules.
Attendance to work is an essential function of this position.
Performs other duties as assigned by Manager/Supervisor.
Special Demands:
Stationary Position: From 1/2 to 3/4 of the day.
Move, Traverse: From 1/4 to 1/2 of the day.
Operate, activate, use, prepare, inspect, or place: From 1/2 to 3/4 of the day.
Install, place, adjust, apply, measure, use, or signal: None.
Ascend/Descend or Work Atop: None.
Position self (to) or Move (about or to): 3/4 of the day and up.
Communicate or exchange information: 3/4 of the day and up.
Detect, distinguish, or determine: 3/4 of the day and up.
On an average day, the individual can expect to move and/or transport up to 10 pounds
less than 1/4 of the day.
QUALIFICATIONS:
Required:
Bachelor's Degree in Industrial Engineering, Packing Engineering or related field
1-3 years related experience and/or training.
College Level Mathematical Skills
Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs.
Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables.
Preferred:
Ability to travel.
Ability to identify and resolve problems in a timely manner.
Ability to work independently and/or as part of a team.
Ability to display excellent time management skils
For Illinois residents: The hiring rate for this position is $58,624--$69,000 plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k).
#LI-JM1
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future
Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
Auto-ApplyValidation Analyst 2
PCI Pharma Services job in Rockford, IL
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. **We are PCI.** Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
The **Validation Analyst II** is responsible for overall validation project ownership of moderate risk project(s) under mild supervision. Responsible for the generation and execution of validation protocols, assistance in audits, and determination of validation needs. This job has no supervisory responsibilities.
**Essential Duties and Responsibilities:** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following, but other duties may be assigned.
Performs validation activities to ensure compliance with government and customer requirements.
Prepares validation protocols, validation statements, reports, summaries, and master validation plans for new customer/product/system project launch and maintains existing validated processes/programs at multiple sites, as well as organizing and coordinating internal and customer approvals, as needed.
Ensures validation documentation completion, accuracy, and closure, including organizing and coordinating multiple approvals as required.
Prepares change control and validation history report for audits.
Attends conference calls and meetings. Effectively communicates project goals and progress to the Validation Supervisor / Manager.
Investigate validation deviations, documenting in formal reports, and ensuring resolution of corrective action to complete the project.
Primary contact for quality validation activities and managing expectations.
Reviews and interprets standards, procedures, and specifications for dissemination relative to validation protocols.
Knowledge of and adherence to all PCI, cGMP, GCP, GAMP, 21CFR, 21CFR Part 11, and Annex 11 policies, procedures, rules, and requirements.
Required to complete and pass a "Documentation Boot Camp" course within 6 months.
This position may require overtime and/or weekend work.
Attendance at work is an essential function of this position.
Performs other duties as assigned.
"Moderate Risk Projects" are generally defined as projects/customer accounts that have the following.
a. Business needs of the customer/project may require additional time commitments.
b. Moderate level of uncertainty in managing customer expectations.
c.Validation approach with moderately complex requirements in addition to the Validation Plan.
d. Established criteria that are subject to some interpretation.
After basic training, this position will be required to specialize in 1 or more Validation areas of focus:
a. Process/Cleaning Validations
b. HVAC/Utility Validations
c. Computer Validations
**Qualifications:** The requirements listed below are representative of the knowledge, _skills_ , and/or _abilities_ required for the stated position. Reasonable _accommodation_ may be made to enable individuals with disabilities to perform the essential functions.
**Required:**
**High School Diploma or GED** and/or 3-5 years related experience and/or training.
**College-Level Mathematical Skills.**
**Intermediate Computer Skills:** Ability to perform more complex computer tasks and know various computer programs.
**Minimum Professional Proficiency:** Ability to speak in a way that allows one to participate effectively in various conversations. Ability to read various types of standard items addressed to general readers.
**Intermediate Reasoning:** Ability to apply common-sense understanding to carry out instructions that may be furnished in written, oral, or diagram form. Ability to deal with problems that involve several concrete variables in standardized situations.
**Preferred:**
**Process/Cleaning Validation Focus:** Background in Packaging, Pharmaceutical, Bio-Pharmaceutical, and/or Medical Devices. Must be able to properly gown and work in an active packaging operation.
**HVAC/Utility Validation Focus:** Familiarity with HVAC wiring diagrams, control design, calibration, instrument configuration, and fundamentals of heating, air conditioning, and refrigeration systems.
**Computer Validation Focus:** _Associate's Degree in a related field and/or 1-3 years related experience and/or training._ Ability to perform complex computer tasks and have some experience with computer systems considered to have an impact on cGMP, cGXP, Annex 11, and PCI guidelines.
**For candidates in Illinois:** The hiring rate for this position is $ $22.15 - $24.92 hourly, plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), a flexible spending account, and a 401(k)
\#LI-SW1
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future (*****************
**Equal Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
Clinical Regulatory Affairs Specialist 2
PCI Pharma Services job in Rockford, IL
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. **We are PCI.** Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
The Clinical Regulatory Affairs Specialist-2 oversees the company's policies and objectives involving matters of government and regulations, with respect to the FDA, DEA, MHRA, EEU, State of Illinois, and other regulatory agencies. This position hosts audits for current and prospective clients. This position does not have any supervisory responsibilities.
**ESSENTIAL DUTIES AND RESPONSIBILITIES:**
+ Write and implement procedures according to the current Code of Federal Regulations.
+ Assure that company policies are properly followed and applied by all appropriate personnel.
+ Assists the Regulatory Affairs Manager by hosting audits, developing appropriate corrective actions documented through the audit reports and ensuring proper implementation.
+ Oversee regular inventories of Controlled Substances for ARCOS reporting and required inventory reports.
+ Acts as a subject matter expert to other internal resources for concepts within 21CFR 210 & 211 as well as the Control Substances Act.
+ Create, review and maintain appropriate Clinical Customer Quality Agreements both globally and site specific.
+ Review and maintain appropriate Site Master Files.
+ Manage and monitor Audit Corrective Actions.
+ Write audit responses pertaining to customer and/or internal observations, and track completion of actions.
+ Review investigations associated with DEA Controlled Products.
+ Submit applicable registration applications.
+ Prepare and present monthly Clinical metrics including Customer specific and overall departmental values.
+ This position may require overtime and/or weekend work.
+ Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
+ Attendance to work is an essential function of this position
+ Performs other duties as assigned by Manager/Supervisor.
**QUALIFICATIONS:**
**Required:**
+ Bachelor's Degree in a related field and/or 5-10 years related experience and/or training.
+ Basic Mathematical Skills
+ Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs.
+ Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
+ High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms.
+ High Standard of Report Writing
**Preferred:**
+ Ability to work independently and/or as part of a team.
+ Ability to demonstrate attention to detail.
+ Ability to identify and resolve problems in a timely manner.
+ Ability to hold oneself in a professional manner.
The base salary hiring range for this position is ($69,920 - $78,660) plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k).
**\#LI-RS1**
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future (*****************
**Equal Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
Engineering Technician
PCI Pharma Services job in Rockford, IL
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. **We are PCI.** Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
**Summary of Objective:**
Work with machines, processes, design to develop technical documents for the department. Conduct machine and process research to develop various product/process quotes.
**Essential Duties and Responsibilities:** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.
+ Develop and implement various technical documents for the department.
+ Research and evaluate machines / equipment, manufacturing processes, customer requirements and other performance criteria to develop quotes for new potential business, utilizing knowledge of materials and parts, fabrication, tooling and equipment capabilities.
+ Confer with cost estimation, production, and maintenance to analyze process improvements, space requirements, workflow, design layout of equipment and workspace to provide quote information.
+ Participate in the development of new and / or modified production projects and participate in various steps of the implementation.
+ Develop documentation to meet anticipated new project requirements with various machines / equipment.
+ Plan and direct various on site and off site testing for new machines / equipment as necessary.
+ Manage multiple priorities under tight deadlines as necessary.
+ Provide training to various departments as necessary.
+ Knowledge of and adherence to all PCI, cGMP and GCP policies, procedures, rules.
+ Able to use various measurement devices such as a ruler, caliper and 32nds / 64ths scale.
+ Attendance to work is an essential function of this position.
+ This position may require overtime and / or weekend work.
+ Perform other duties as assigned by Manager / Supervisor / Director.
**Qualifications:** The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
**Required:**
+ Bachelor's Degree in a related field and/or 3-5 years related experience and/or training.
+ Statistical and Advanced Mathematical Skills
+ Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs
+ Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
+ High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms.
+ Excellent communication skills, written, verbal.
+ Pharmaceutical Experience
**Preferred:**
+ Ability to effectively present information to various people as the job requires.
+ Ability to follow instructions and respond to management direction.
+ Ability to work independently and / or as part of a team.
+ Ability to demonstrate attention to detail.
+ Ability to hold oneself in a professional manner.
+ Ability to set and achieve changing goals.
+ Ability to learn and / or take courses in Blue Print Reading and Solid Works as the job requires.
The base salary hiring range for this position is ($56,720 - $70,900) plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k).
\#LI-SW1
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future (*****************
**Equal Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
Clinical Label Control Coordinator
PCI Pharma Services job in Rockford, IL
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Summary of Objective:
Direct point of contact for customers and vendors relating to clinical labeling to effectively communicate technical requirements for packaging purposes by understanding equipment functions, component designs, material structure, code and coding areas, and barcode data structures.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Demonstrate facilitation of various component label copy revisions and successful management of customer art and vendor print proof files by understanding different processes defined by customer and vendor requirements.
Independent decisions to complete technical approval reviews including component drawings and vendor die lines, customer artwork, and vendor print proofs to ensure component design, barcode, and coding areas align with PCI packaging process as well as performing barcode scans and verifying barcode type, encoded data, density or cell size, and structure are accurate.
Design labels to print internally (PCI Label Room); label copy and barcode data structures created per GS1 (Global Standards) and customer logistics, distribution center requirements that include standards for track and trace (serialization), HDMA (Healthcare Distribution Management Association), and HIBCC/UDI (Healthcare Industry Business Communications Council/Unique Device Identification).
Direct point of contact to process internal drawings and vendor die lines through customer approvals.
Proofreading accuracy and ability to multi-task in a fast paced environment.
Manage clinical randomization files including creation and comparison inspections.
Schedule and host conference calls, meetings with customer and vendor representatives, as needed.
. Participate in Clinical trial operation planning meetings as required, interact with project manager, QC/QA, production, planning, validation and warehouse to ensure that jobs are completed in a timely manner minimizing delays to production.
Assisting in the hosting of external and internal audits of the Labeling Department
Complete component specification, LE form, and batch record reviews within SmartProd-Pilgrim.
Conduct efficient and accurate departmental handover meetings prioritizing workload in line with production scheduling
QUALIFICATIONS:
Required:
High School Diploma or GED and/or 3-5 years related experience and/or training.
Basic Mathematical Skills
Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs.
Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms.
Preferred
Ability to effectively present information to various people as the job requires.
Ability to display a willingness to make decisions.
Ability to work independently and/or as part of a team.
Ability to exhibit sound and accurate judgment.
Ability to demonstrate attention to detail.
Ability to identify and resolve problems in a timely manner.
Assist in the training of others to use the label printing systems.
Work in a safe manner at all times and highlight any safety issues to the appropriate person as soon as possible.
Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
This position may require overtime and/or weekend work.
Attendance to work is an essential function of this position
Performs other duties as assigned by Manager/Supervisor
The hiring rate for this position is $16.50-18.56/hour plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k).
#LI-AK2
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future
Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
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