Quality Analyst
PCI Pharma Services job in Philadelphia, PA
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 Analyst
Location: Philadelphia, PA.
Department: Quality
Shift: Day Shift, 8am 430pm
Reporting To: Director, Quality Systems
Responsible For (Staff): None
Job Summary
PCI is seeking a Quality Analyst with a strong background in Quality with the primary function of conducting customer complaint investigations. The individual also performs support functions related to maintaining the overall Quality Management System.
Essential Duties and Responsibilities:
Receive communications from customers related to complaints
Log complaints into the QMS system
Conduct investigations utilizing root cause analysis tools and work with other functional areas to identify the cause and appropriate corrective and preventive actions
Draft and peer review customer complaint investigations
Communicate directly with clients in resolution of customer complaints
Compile metrics for the functional area
Assist with compiling information for regulatory filings
Responsibility will include some facets of maintaining and improving the
overall Quality Management
Systems (i.e. internal audits, CAPA effectiveness, change control)
Qualifications:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
Required:
High school education or at least five (5) years of pharmaceutical or pharmaceutical packaging experience.
A college degree with a concentration in a scientific discipline is preferred.
Possesses excellent organizational, time management and multi-tasking skills in order to meet commitments and deadlines.
The candidate must be able to demonstrate basic proficiency with personal computers, business software (e.g., MS Office) and technical software (e.g., TrackWise).
Ability to create, use and interpret scientific tables, charts, and graphs.
Prior experience in technical writing and utilizing root cause analysis tools is preferred.
Any Lean Six Sigma or process improvement training is a plus
Highly developed oral and written interpersonal communication skills to effectively communicate with company management, customers, suppliers, and agencies at all levels.
Strong problem-solving skills
#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.
Auto-ApplyTalent Acquisition Specialist/Recruiter - Finance and Tech
PCI Pharma Services job in Philadelphia, PA
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:**
**Recruiter/Talent Acquisition Specialist - Finance and Technical Roles**
The Recruiter acts as a talent acquisition partner to Corporate functions in North America, primarily in Finance and IT/Technology, to facilitate the achievement of business goals as it relates to full cycle recruitment. Implement creative sourcing techniques, interview, extend offer and onboard successful new hires across multiple sites in the PCI network. Develop and execute search strategies that are measurable, focused on continuous improvement, & results oriented.
If you are a self-starter, excited by the challenge of managing hard to fill roles, and work well independently, you will thrive here.
**RESPONSIBILITIES:**
· Manage the full life-cycle recruitment process at multiple sites including sourcing prospective candidates, screening and interviewing candidates, creating and extending competitive offers and ensuring successful new hire starts.
· Collaborate with the broader TA team and hiring managers to develop a compelling recruitment & sourcing strategy to hire according to projected staffing plans and increase efficiency of Talent Acquisition.
· Work directly with hiring managers on sourcing and recruitment strategies, candidate management, interview and selection approach.
· Liaise between internal and external candidates and hiring managers.
· Engage with a diverse range of hiring managers to teach effective interviewing and assessment skills.
· Develop strong hiring manager partnerships and collaborate to make informed hiring decisions.
· Ensure the best candidate experience throughout the complete interview processes
· Lead interview debriefs and gather standardized interview feedback
· Effectively work within internal Applicant Tracking System (Workday), including requisition initiation and management, candidate communications, candidate dispositioning, and candidate workflow management
**QUALIFICATIONS/REQUIREMENTS:**
+ Bachelor's degree preferred and 5+ years of related human resources or talent acquisition experience
+ Minimum of 5+ years of full life cycle recruiting experience
+ Proven experience recruiting for Finance, Accounting, IT and Technical roles
+ Experience working within Workday Recruiting
+ Experience within the pharmaceutical or biotechnology industries strongly preferred
+ Experience managing confidential and personal information and knowledge of employment laws and best practices
+ Proficiency in Microsoft Office Suite products
+ Excellent organizational and time management skills
+ Ability to prioritize work and successfully multitask a variety of assignment
+ Excellent collaboration skills and ability to work cross-functionally
+ Strong written and verbal communication skills
+ Strong knowledge of HR policies, procedures, and federal/state legislation
For candidates in Rockford, Illinois, the hiring range for this position is $69,920 -$78,660 annually, 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
Warehouse Worker
PCI Pharma Services job in Philadelphia, PA
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:** Warehouse Worker
**Department/Group:** Warehouse
**Location:** Phyllis Drive
**Reports to:** Warehouse Supervisor/Manager
PCI Pharma is seeking qualified Warehouse Workers to join our dynamic team! PCI is your world leading CDMO providing integrated end-to-end drug development, manufacturing, and packaging solutions to increase product speed to market. In this role as a Warehouse Worker, you will be responsible for optimizing loads to ensure operational efficiency, managing inventory by utilizing RF scanning equipment, among other duties. The Warehouse Worker must have prior experience as a forklift driver. The Warehouse Worker will join the USW Local 286 after successful completion of probation.
**Essential Duties and Responsibilities:**
+ Stack and unstack large quantities of goods onto shelves or pallets.
+ Secure loads to the machine to ensure operational efficiency and transport to different locations within the facility.
+ Correctly scan materials with an RF scanner for inventory purposes.
+ Process distribution orders for site or depot shipments. This includes the picking, packaging and shipping of supplies using both JDE and courier software for dispatch.
+ Maneuver a forklift (either a standard electric "sit down" fork truck or a double reach "stand up" material handling truck), electric pallet jack, and other material handling equipment safely, expediently, skillfully, while transporting full or partial pallet loads of material throughout the plant, and into/out of rack fixtures.
+ Accurately record, both manually and electronically, the movements of material.
+ Perform the staging, issuance and delivery of work orders for commercial production.
+ Quality control: Ensure that only undamaged products are sent out.
+ Adhere to housekeeping and safety management standards.
+ This position may require overtime and/or weekend work.
+ Knowledge of and adherence to 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:**
+ **Stationary Position:** From 1/4 to 1/2 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:** 3/4 of the day and up.
+ **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 50 pounds between 1/4 and 1/2 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 following are some environmental conditions that one may be exposed to on a daily basis and for various lengths of time.
+ Work in high, precarious places for 1/4 to 1/2 of the day.
+ Extreme cold (non-weather) for 1/2 to 3/4 of the day.
+ Outside weather conditions for 1/4 to 1/2 of the day.
+ Work near moving mechanical parts for 1/2 to 3/4 of the day.
+ The noise level in the work environment is typically, loud.
**Qualifications:**
**Required:**
+ High school diploma, GED, or equivalent
+ Forklift certification and the ability to drive a sit-down and standup forklift.
+ For standup forklift at least 12 months experience and for sit-down at least 6 months experience.
+ Basic Mathematical Skills
+ Basic Computer Skills: Ability to perform basic computer tasks and has the ability to operate common 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.
+ Must be able to lift routinely, up to 50 pounds.
**Preferred:**
+ Ability to work independently and/or as part of a team.
+ Ability to demonstrate attention to detail.
+ Excellent hand-eye coordination.
+ Ability to adapt to changing work environments.
+ Ability to display excellent time management skills.
+ Able to work long hours on one's feet and perform physically demanding tasks.
+ Proficiency in operating technical machinery and RF scanners.
+ Previous experience in a GMP environment is ideal.
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 Systems Manager
PCI Pharma Services job in Philadelphia, PA
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 Quality Systems Manager is responsible for overseeing and maintaining the Electronic Quality Management System (eQMS) to ensure compliance with regulatory requirements and industry standards. This role leads the implementation, administration, and continuous improvement of quality systems processes including Deviations, Change Controls and Corrective and Preventative Actions (CAPA). The Manager will also drive initiatives to analyze quality data, identify trends, and implement improvements that enhance product quality and operational efficiency while developing employee competencies through targeted training programs.
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.
Quality Management System Oversight
Manage and administer the Electronic Quality Management System (eQMS), ensuring all related documentation is compliant with applicable procedures and regulations
Co-Chair Change Control and CAPA review boards, providing leadership in decision-making processes
Develop, implement, and maintain robust quality metrics to drive continuous improvement within the quality systems
Conduct trend analysis of nonconformances, deviations, and complaints to identify patterns requiring systemic solutions
Ensure compliance with FDA regulations, ISO 13485, Medical Device Directive, and other applicable standards and regulations
Corrective and Preventative Action (CAPA) Management
Manage the CAPA system to ensure appropriate investigation, implementation, closure, and effectiveness checks meet required timelines
Analyze root causes of quality issues and implement effective corrective and preventative actions
Track and trend CAPA data to identify systemic issues requiring organizational attention
Lead cross-functional teams to address complex CAPA investigations and implementations
Change Control and Deviation Management
Administer the change control system, coordinating the initiation, execution, and completion of changes
Track timely completion of change control commitments and manage extension requests
Oversee the deviation management process, ensuring timely execution, closure and resolution
Quality Data Analysis and Reporting
Establish, manage, and track quality system performance metrics to drive continuous improvement; Report to leadership, highlighting areas of concern and improvement opportunities
Conduct regular trend analysis across quality systems to identify proactive improvement initiatives
Prepare and present quality data for management review meetings
Cross-Functional Collaboration and Leadership
Collaborate with cross-functional teams to drive quality initiatives and resolve quality issues
Lead interactions between different departments to ensure quality requirements are understood and implemented
Support and participate in external audits including FDA, customers, and corporate audits
Team Development and Management
Build, develop, and retain a strong quality systems team through effective hiring, training, and motivation
Provide supervision, mentoring, and development to direct reports
Set goals and objectives for the quality systems team aligned with organizational objectives
Foster a culture of quality awareness, continuous improvement, and regulatory compliance
Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability 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 (Science, Engineering, or Quality) and 5-10 years related experience in a regulated environment
Demonstrated expertise in quality management systems and regulatory requirements (FDA, ISO 13485, Medical Device Directive)
Strong knowledge of cGMP and other applicable regulations
Experience with electronic quality management systems, preferably Master Control
Excellent analytical and problem-solving skills with the ability to identify trends and implement improvements
Strong leadership skills with experience managing and developing teams
Exceptional written and verbal communication skills
Advanced computer skills and proficiency with quality management software
#LI-LM1
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-ApplyLine Leader 1st shift
PCI Pharma Services job in Philadelphia, PA
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: Line Leader
Reporting: Production Supervisor
Location: Philadelphia, PA
Essential Functions: Line Leader
+ Leads the operations and activities of the production team within the room to ensure that throughput is maximized, while sustaining safety, quality, and timeliness.
SPECIFIC DUTIES, ACTIVITIES, AND RESPONSIBILITIES:
Pre-production responsibilities & activities:
+ Reads and reviews the MPI's, relevant SOPs, and the shop floor packet prior to job start-up, to identify and understand all production, validation, and/or special requirements (e.g., temperature, humidity, etc.).
+ Determines the placement of personnel on the production line, according to quality critical skill sets required at each line station.
+ Verifies line clearance and completes required Line Clearance and Use Begin forms prior to start-up.
+ Checks all incoming components against the batch record to verify that they are correct.
+ Documents receipts in the batch record.
+ Fills out In-Process and Reject labels prior to job start-up.
+ Reads MPI's and other production requirements to the room crew prior to job start-up, ensuring that all personnel thoroughly understand the quality and process requirements of their assigned position.
+ Ensures that all line personnel sign the required sections of the batch record and training sheets, and initial their assigned station on the line diagram.
+ Perform start-up and in-process quality inspections, testing and sampling.
+ Perform periodic reviews of the batch record throughout the production operation to ensure cGMP compliance and completion and accuracy of the appropriate pages.
+ Notify QA and Production Supervisor when tests and/or inspections do not pass
+ Verify all coded information (lot number and expiration date) are set correctly throughout the packaging line, and completes all qualified challenges on a production line.
+ Ensure that equipment calibration dates in preproduction rooms are within required specifications and contacts appropriate personnel to recalibrate as required.
Ongoing responsibilities & activities:
+ Ensures that all operations and personnel within the room are trained and in strict compliance with the MPIs and applicable safety and quality procedures and regulations.
+ Ensures that all packaging strictly conforms to MPI and PCI specifications.
+ Ensures that the room remains clean throughout the production run.
+ Documents, monitors and helps control Constraint Downtime and Buffer Management within the room so as to maximize throughput.
+ Ensures that mechanical and production resources, machine speeds and productivity are in accordance with the quantities and rates estimated for the job.
+ Identifies the constraint and manages the buffer (according to the Management of the Buffer in the Production Room Guidelines).
+ Monitors material and waste quantities and communicates additional material needs to the Production Supervisor.
+ Provides production status updates to the Production Supervisor on a regular basis throughout the shift.
+ Reports all paperwork issues and discrepancies and material delays to the Production Supervisor for resolution.
+ Ensures that room cleanliness is maintained throughout the production run.
+ Reports any violation of company and/or safety policies, cGMPs, and the Collective Bargaining Agreement to the Production Supervisor for action.
Post-production activities & responsibilities:
+ Reviews batch record and reconcile all materials at the end of production.
+ Completes the required sections of the batch record in accordance with cGMP regulations.
POSITION REQUIREMENTS:
+ Must possess and demonstrate leadership qualities and be a motivator of people.
+ Must be dependable and show initiative to improve the overall production process.
+ Must be detail and quality oriented.
+ Must possess and demonstrate average verbal, written and interpersonal communications skills.
+ Must possess average mathematical skills.
+ Must work well under pressure.
+ Must be able to interact effectively with a variety of individuals and personalities within and between departments.
+ Must possess and demonstrate knowledge and experience in cGMPs.
Reports to:
+ Production Supervisor
Supervises:
+ Line personnel
Education:
+ High school diploma or equivalent
Experience or Equivalent:
+ 2+ year's experience in a production environment
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._
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 Specialist Document Control
PCI Pharma Services job in Philadelphia, PA
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 Quality department is responsible for creating/maintaining the Quality Management System (QMS) for the Philadelphia facility. This Quality Management System includes Documentation Control, Investigation and CAPA Management, Training, Internal/External Audits, Customer Correspondence, Validation.
This position reports to the Senior Training Manager, and is responsible for all the upkeep, maintenance and control of all QA related documents. Such documents include SOP's, forms, regulatory documents etc. Wherever possible, documentation best practices should be applied consistently across the facilities.
**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 maintaining the electronic SOPs and forms files on the shared drive.
+ Responsible for maintaining the databases for SOPs and forms.
+ Responsible for maintaining the SOP manuals and ensuring these manuals are always up to date.
+ Responsible for batch record optimization. While this position is not responsible for the completion of batch records, they do have responsibility for ensuring that the batch record documents are optimized, consistent and managed effectively.
+ Responsible for tracking and initiating periodic review of controlled QA documents (e.g. SOPs, forms, etc.).
+ Works closely with the QA Business Units to ensure that documentation best practices are consistent with the QA systems landscape.
+ Works closely with QA Director, QA Business Units and Operations Management. Responsible for the processing and tracking of controlled QA documents (e.g., SOPs, forms, etc.) from creation/revision through approval, distribution, filing and retention of current and historical documents.
+ Provide timely and accurate reports and assessments of problems or potential problems to the Senior Training Manager.
+ Assist with customer audits of the facility as required.
+ Assist in preparing the site for inspection by regulatory authorities.
+ Participate in regulatory inspections as required.
+ Develop new Quality System procedures, and review and update existing procedures.
+ Represent QA on project teams, management teams and other internal forums.
+ Contribute to process improvement initiatives across the organization.
+ Comply with Health, Safety & Environmental responsibilities for the position.
+ Other responsibilities as assigned.
**EDUCATION AND/OR EXPERIENCE:**
+ Strong interpersonal skills.
+ Basic knowledge of Lean Six Sigma and FDA cGMP's preferred.
+ Experience in Pharmaceutical industry preferred.
+ Experience in Printed industry preferred.
**LANGUAGE SKILLS:**
+ Good Communication Skills-Written and verbal.
**KNOWLEDGE/SKILLS REQUIREMENTS:**
+ Communication Skills: Written, Oral, Presentation, Candid, and direct feedback.
+ Technical Skills: Computer Literate (Microsoft Office - Word, Excel, PowerPoint, Outlook; Visio; Access, Network - Imaginer); Performance aspects of position.
+ Analytical Skills: Situation Appraisal; Problem Analysis; Decision Analysis; Potential Problem/Opportunity Analysis; Statistical Analysis.
+ Interpersonal Skills: Able to work in a team environment.
+ Quality Awareness: Quality System ISO; Statistical Process Control; Continuous Improvement, cGMP's.
+ Diversity / Multi-Cultural Work Environment.
**COMPUTER SKILLS** **:**
Good Computer Skills. Knowledge of MS Office, Word, Excel, PowerPoint, Outlook; Visio; Access, Network - Imaginer); Performance aspects of position.
\#LI-DT1
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
Mechanical Manager
PCI Pharma Services job in Philadelphia, PA
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: Mechanical Manager
Location: 3001 Red Lion Road, Philadelphia, PA 19114
Department: Operations
Shift: 1st Shift
Reporting To: Operations, Senior Director
JOB SUMMARY:
Are you a visionary leader with a passion for driving change and innovation? Join our dynamic and growing business as a Mechanical Manager, where you'll lead our Mechanical organization to new heights of Operational Excellence.
This pivotal role is responsible for overseeing all aspects of Mechanical Maintenance, including Electrical Technicians and Mechanics (Levels 1-3). You'll spearhead system improvements, standardize processes, and advance technology to foster continuous improvement within our Mechanical Department.
The Mechanical Manager will be responsible for managing the mechanical operations and maintenance activities within the facility, with a particular focus on automation equipment. This role requires a strong focus on ensuring the reliability and efficiency of mechanical systems and equipment. The ideal candidate will have extensive experience in mechanical maintenance, team leadership, and operational management, with a preferred background in engineering.
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.
Oversee and manage the daily operations of the mechanical maintenance team.
Develop and implement maintenance schedules and procedures to ensure optimal performance of mechanical systems, equipment, and automation technologies.
Conduct regular inspections and preventive maintenance to minimize downtime and extend equipment lifespan.
Troubleshoot and resolve mechanical and automation-related issues promptly to maintain operational efficiency.
Coordinate with other departments to ensure seamless integration of maintenance activities with overall operations.
Manage and mentor a team of mechanical technicians, providing guidance and support to enhance their skills and performance.
Monitor and control maintenance budgets, ensuring cost-effective use of resources, and resolve escalated issues arising from operations, requiring coordination with other departments.
Identify opportunities for process improvements and implement best practices to enhance operational efficiency.
Maintain accurate records of maintenance activities, equipment performance, and inventory levels.
Ensure compliance with safety regulations and industry standards.
Oversee the design, fabrication, operation, application, installation, and repair of mechanical products such as engines, instruments, controls, robots, and machines.
Adhere to all PCI, cGMP, and GCP policies, procedures, and rules.
Perform other duties as assigned by the Senior Director of Operations.
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.
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.
Work is performed in areas with moderate risk or discomfort that may require special safety precautions, such as wearing protective clothing or gear for 3/4 of the day and up.
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 up to 1/4 of the day.
Risk of electrical shock for up to 1/4 of the day.
The noise level in the work environment is typically, moderate.
Qualifications:
Required:
Bachelor's Degree in Engineering or a related field OR 5-10 years of related experience and/or training.
Proven experience in mechanical maintenance and operations management, with a focus on automation equipment.
Ability to lead and motivate a team, manage conflicts, and make decisions that benefit the organization.
In-depth knowledge of mechanical systems, engineering principles, and industry standards.
Excellent problem-solving and troubleshooting abilities.
Knowledge of maintenance management software and tools.
Familiarity with safety regulations and industry standards.
Strong communication and interpersonal skills.
Ability to work in a fast-paced and dynamic environment.
Preferred Qualifications:
Advanced Degree: A master's degree in Mechanical Engineering or related field.
Familiarity with emerging technologies such as automation and robotics
Experience managing union hourly workers.
Experience in specific industries such as manufacturing, med device, automotive, aerospace, or energy.
Experience in planning, executing, and overseeing projects to ensure they are completed on time and within budget.
Professional certifications in maintenance management or related areas
Experience with lean manufacturing and continuous improvement methodologies.
Experience with ERP Systems: Knowledge of Enterprise Resource Planning (ERP) systems like SAP or Oracle.
Strong Analytical Skills: Ability to analyze complex data and make data-driven decisions.
#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.
Auto-ApplyMaster Scheduler Manager (Scheduling / Production Planning)
PCI Pharma Services job in Philadelphia, PA
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:
Lead and Manage customer forecast data and site production progress to ensure long range and short-term production plans/schedules are on track to meet delivery targets. Ensure created production plans and schedules align with site and warehouse capacity. Upon customer request, update production plans as needed with minimal impact on the production site. Oversee the development and execution of the long-range and short-term production plants, ensuring schedules meet organizational objectives and customer commitments. Own the weekly planning cycle and daily schedule maintenance processes, providing strategic direction and oversight to ensure consistency, accuracy and agility. Prepare and deliver high-quality planning and forecast reports to site leadership, offering insights and recommendations to support data-driven decision making and continuous improvement.
Essential Duties & Responsibilities:
Lead and manage customer forecasts (short-term and long-term) to ensure alignment with customer demands, driving timely aggregation of forecast data for all production lines and rooms across entire site.
Represent planning in customer meetings to conduct capacity scenario planning and long-term plans by leveraging operational knowledge to balance customer demand with capacity constraints for all production lines and room across entire site.
Oversee the analysis and validation of forecast data, identifying variance and outliers. Communicate key findings and insights to senior leadership, ensuring customer orders align with forecast assumptions and long-term production strategies.
Direct the development and maintenance of site-wide production schedules that guide production activities - ensuring alignment with labor and equipment efficiency, timeline objectives and customer commitments.
Integrate cross-functional inputs including material readiness, capacity (equipment, production suites), inventory levels, resource availability, and delivery timelines into the production planning process to ensure readiness and feasibility.
Proactively identify and resolve scheduling, leading resolution of conflicts and potential delays. Develop and propose alternate scenarios that minimize business disruption and maintain adherence to customer and organizational priorities.
Partners with Operations and Business Unit to resolve line conflicts, streamline the schedule, ensure original promise dates are met, and ensure monthly financial targets are achieved.
Oversee utilization of ERP systems, (JDE), planning tools and reporting systems to ensure accurate, real-time production scheduling and performance tracking.
Provide strategic input to the SIOP process, especially as it relates to volume and capacity. Lead the ongoing development of and reporting of Forecast Accuracy and Schedule Attainment KPIs to support operational performance and business planning.
Participate in and guide daily production meetings, ensuring planning considerations and constraints are understood and integrated into daily operations.
Ensure accuracy of supplemental planning data and throughput rates per SKU, overseeing regular review and updates to maintain high-quality planning outputs.
Performs other duties as assigned by Manager/Supervisor.
This position may require overtime and/or weekend work.
This position requires knowledge of and adherence to all PCI and cGMP policies, procedures, and rules.
Qualifications
Required:
Bachelor's Degree in a related field and/or 7-10 years related experience and/or training.
Leadership experience
College Level Mathematical Skills
Advanced Computer Skills: Ability to perform the most complex computer tasks and operate 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 work independently and/or as part of a team.
#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-ApplyASRS/Warehouse Facilities Level II (Weekend AM Shift)
PCI Pharma Services job in Philadelphia, PA
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: Facilities ASRS Worker - Level II**
**Department:** Facilities
**Schedule:** 24/7 AM, Friday-Sunday (8:00 am -8:00 pm)
**Location:** Philadelphia, PA - ASRS/Warehouse
**Position Summary:**
The Facilities ASRS Worker Level II is responsible for performing a wide range of technical, mechanical, and facility-related tasks to support the operation and maintenance of PCI's ASRS and warehouse systems. This role requires a strong technical background, hands-on experience with facility systems, and the ability to work independently or as part of a team in a 24/7 environment.
**Key Responsibilities:**
+ Perform medium-level repairs in painting, spackling, plumbing, carpentry, and furniture assembly/installation.
+ Conduct preventive maintenance on air handlers and ASRS equipment.
+ Troubleshoot and repair Facilities Equipment including:
+ ASRS Crane systems
+ Conveyor systems
+ Trash compactors and balers
+ Air handlers, chillers, boilers, dehumidifiers, humidifiers
+ Electrical power systems
+ Support and lead repair projects from start to completion.
+ Identify and implement improvement opportunities across facilities.
+ Use PCI's ordering system to identify and procure necessary parts.
+ Work directly with vendors for troubleshooting equipment and repairs.
+ Understand and operate Honeywell Station modules (HVAC, Fire, Utilities) at Supervisor Security Level.
+ Perform basic to advanced electrical troubleshooting.
+ Conduct rigging and relocation of heavy equipment.
+ Support and train Facilities Worker Level 1 team members.
+ Maintain familiarity with all PCI buildings and grounds.
+ Follow all safety protocols and company procedures.
**Required Qualifications:**
+ Recognized technical and mechanical education/training.
+ Official forklift training/permit.
+ Basic locksmithing skills, including key making.
+ Welding training and ability.
+ Strong understanding of:
+ HVAC, chilled/hot water, compressed air, and clean air systems
+ Electrical power systems supporting facility equipment
+ Ability to troubleshoot systems to the major component level.
+ Experience with ASRS systems and preventive maintenance.
+ Ability to prioritize tasks and manage workload independently.
+ Strong communication and teamwork skills.
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
Business Unit Director
PCI Pharma Services job in Philadelphia, PA
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:**
Develop the customer relationship through Customer Focused teams of dedicated employees to provide an 'industry leading customer experience'. Develop specific customer strategies with the Account Executive and monitor attainment of projects and goals. Provide leadership and direction to the teams to ensure the groups are performing within prescribed timelines and budget. Collaborate with other BUD's and internal departments to ensure the use of best practices within appropriate guidelines.
**Essential Duties & Responsibilities:**
+ Interact with other business units and functional departments to define production plans, yearly goals and budgets.
+ Establish business unit and individual goals and objectives in alignment with site goals and customer requirements.
+ Primary customer contact for business and relationship issues.
+ Manage short-term and long-term customer forecasts.
+ Quarterly customer meetings/business reviews: accountable for meeting, success, develop agenda, coordinate meeting details with customer and PCI internal staff, lead the organization in detail preparation, lead meetings, insure professional follow-up on all open items
+ Oversee business and quality issues.
+ Manage customer visits to PCI.
+ Adherence to PCI and cGMP policies, procedures, rules and regulations.
+ Attendance to work is an essential function of this job.
+ Other duties as assigned by Supervisor/Manager.
**Core Attributes:**
+ Act as a positive role model that accomplishes and supports management objectives and diversity.
+ Assists in diffusing conflicting situations. Communicates clear directions and holds employees accountable.
+ Celebrates and rewards significant achievements of others.
+ Builds trusting coaching relationships.
+ Helps people assess their skills and identify development objectives.
+ Ensure annual performance reviews are written for each employee within reporting structure. Complete and submit documentation, as necessary, for any required human resource actions.
**Supervisory Responsibilities:**
+ Supervise approximately two or more associates within the Project Management function.
+ Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.
+ Responsibilities include interviewing, hiring, and training employees; staffing, planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
**Qualifications:**
This position requires a history of project accomplishments and demonstrated leadership excellence preferably as a project manager at PCI. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
**Required:**
+ Minimum four years' experience in the pharmaceutical and/or packaging industry or a related field, with a history of project accomplishment and leadership excellence in the project management arena. Preferred packaging and/or pharmaceutical experience.
+ Bachelor's or Master's degree from four-year college or university; Packaging Science degree preferred.
+ Must have excellent computer skills including Microsoft Word, Excel, PowerPoint, Outlook, and Project, and a working knowledge of GMPs.
+ Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry.
+ Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
+ Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
+ Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
**\#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
Inventory Analyst
PCI Pharma Services job in Philadelphia, PA
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: Inventory Analyst
Location: Philadelphia, PA- Red Lion Road
Department: Warehouse
The Inventory Analyst is responsible for conducting periodic cycle counts, investigating and correcting inventory discrepancies, assisting in destructions, and other duties as deemed necessary by management. This person will support both operations and the business unit by running reports, collecting samples and verifying inventory as needed and will be expected to conduct themself in a professional and respectful manner at all times to facilitate a positive work environment.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Investigate and resolve inventory discrepancies
• Assist in conducting and recording periodic cycle counts
• Assist in completing and documenting destructions
• Assist with audits, both internal and external
• Pull samples as requested
• Support control drug / vaults
• Assist maintaining the Quarantine and Reject cages
• Run and supply reports as requested by Operations or the Business Unit
• Physically confirm inventory as requested by Operations and Business Unit
• Special projects
• 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.
On an average day, the individual can expect to move and/or transport up to 25 pounds
QUALIFICATIONS:
Required:
• 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 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
Equal Opportunity Employer/Vet/Disabled
#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.
Auto-ApplyGlobal Compensation Analyst
PCI Pharma Services job in Philadelphia, PA
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.
As a Global Compensation Analyst at PCI Pharma Services, you will support design, development, and administration of comprehensive compensation programs in a fast-paced, global organization. You will support a variety of initiatives, including job evaluations, market analysis, classification programs, benchmarking, salary structures, and special pay studies. This role offers you the opportunity to contribute to the development and delivery of base pay, incentive plans, merit increases, and total rewards programs across the organization. You will partner with key stakeholders to drive compensation strategies that align with business objectives and foster a competitive and equitable environment.
**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. (For example: List the duties in the order of importance)
**Responsibilities:**
+ Serve as a compensation subject matter expert alongside the Senior Director Global Compensation and Benefits, to support the benchmarking of new and existing roles ensuring market competitiveness through advanced data-driven job evaluations and strategic recommendations.
+ Support the Advanced Compensation module within the HRIS, overseeing the administration of merit increases and incentive compensation programs.
+ Support and contribute to compensation projects and market studies from inception to implementation, including analyzing data, salary recommendations, creating cost projections, developing and facilitating training presentations, and communication plans.
+ Contribute to the oversight of the compensation software integration with HRIS systems, ensuring smooth processes and updated structures for annual merit and incentive compensation.
+ Act as a point of contact for compensation-related inquiries, providing strategic guidance on matters such as new hires, job reclassification, transfers, location changes, promotions, and other employee lifecycle movements.
+ Leverage advanced analytics and compensation modeling tools to provide actionable insights, helping to shape compensation decisions and develop long-term compensation strategies.
+ Work closely with global stakeholders to ensure alignment of compensation programs across regions, ensuring consistency and market competitiveness while adhering to local compliance regulations
+ Prepare and submit annual compensation surveys to gain access to critical industry data and insights.
+ contribute to change management efforts related to compensation programs, ensuring smooth transitions during program modifications or organizational shifts.
+ Support the administration of the annual merit and incentive compensation processes, including system administration, updating salary matrices, guidelines, and tools, and preparing communication and training materials.
+ Collaborate with senior leadership to provide strategic recommendations on promotions, compensation strategy, and pay-for-performance models, aligning compensation programs with business priorities and goals
+ Develop and facilitate training materials, ensuring effective rollouts and knowledge transfer on compensation programs and enabling knowledge transfer across teams for better alignment with organizational objectives.
+ Develop recommendations in administering compensation programs, includingmarket analysis, geographic salary structure assessments, and salary spending guidelines.
+ Monitor compensation trends and make recommendations for innovative programs and policies, adapting to market and organizational changes.
+ Collaborate with leaders across the business to provide guidance on effective reward strategies and assist in the resolution of compensation-related challenges.
+ Play a role in M&A activities, particularly regarding compensation harmonization efforts, and support relevant projects as assigned.
+ May require occasional travel to other site locations, and extra hours or weekend work during peak periods.
**Requirements:**
+ 3 to 5 years of experience in compensation analysis within a fast-paced, high-growth business environment.
+ Proficiency in compensation analysis methodologies, including designing and managing salary structures, annual salary reviews, promotions, incentive programs, and market benchmarking.
+ Strong analytical and strategic thinking skills with the ability to interpret complex data and make actional, data-driven strategic recommendations that influence stakeholder decisions.
+ Advanced proficiency in HRIS systems (e.g., Workday) and compensation software, including administration of merit and incentive processes.
+ Exceptional Excel skills for data analysis, reporting, and trend identification.
+ Proven ability to manage complex projects from start to finish, including market studies and cost projections.
+ .
+ Experience in developing and delivering compensation training to non-compensation professionals, with the ability to translate complex compensation concepts into clear, actionable information for stakeholders
+ Strong communication and presentation skills, capable of delivering complex information in clear and actionable terms.
+ High integrity, discretion, and judgment in handling confidential compensation data.
+ Strong reasoning and problem-solving skills, with the ability to handle situations with limited standardization.
+ Ability to work independently and as part of a collaborative team in a fast-paced, global environment.
+ Knowledge of compensation trends, regulations, and innovations across global markets, including the US, UK, Spain, Canada, Australia, Ireland, and Germany.
+ College-level mathematical and statistical skills, with high-level report writing and presentation abilities.
+ Exceptional time management skills and ability to balance multiple tasks and deadlines.
\#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
Scheduler Dock
PCI Pharma Services job in Philadelphia, PA
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:**
Performs scheduling, communication, and administrative functions to coordinate routine daily control of distribution logistics activities.
**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.
+ Maintains Shipping & Receiving Dock Schedule. Slots appointments with Carriers, Customers, and Suppliers. Identifies resource constraints and works with designated Management and Supervisory personnel to resolve. Includes inter-warehouse transfers.10 - 20%
+ Prepares and issues receiving paperwork to Shipping / Receiving personnel. Enters and/or validates initial purchase order receipt information.
+ Generates product labels for some materials.
+ Works with Quality Inspection personnel to assure timely & accurate receipts.40 - 70%
+ Processes Supplier performance tracking information. Notifies Supply Schedulers or other procuring personnel of delayed or impaired receipts and confers requests for early deliveries.
+ Works with Material Control & Payables to resolve receipt discrepancies.5 - 15%
+ Administers small package receipt and shipment.5 - 20%
+ Supplements Shipping Clerk in shipment administration activities: Prepares and issues shipping paperwork to Shipping / Receiving personnel. Enters and/or validates order picking and final shipment information.0 - 15%
**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.
+ Capability to maintain focus and appropriate demeanor in a fast-paced environment.
+ Capability to organize work and manage job priorities.
* Note: prior experience in a distribution logistics environment would speed learning.
**EDUCATION OR EQUIVALENT:**
+ High School Diploma or equivalent. 2-4 years relevant experience
+ LANGUAGE SKILLS: Good interpersonal communication capability
+ MATHEMATICAL SKILLS: Basic Math Competency
+ COMPUTER SKILLS: Basic Computer competency
\#LI-DT1
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 Engineer I
PCI Pharma Services job in Philadelphia, PA
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 Summary
We are looking for a dedicated Continuous Improvement Engineer I to lead continuous improvement activities for the site. The Continuous Improvement Engineer I will identify and track opportunities, recommend and implement strong technical solutions and robust processes, and evaluate the organizational impact of in-process and completed projects.
All activities are focused on deploying the continuous improvement strategy for the site, which includes but is not limited to process improvements, process optimization, standardization, and implementation of best practices in all areas of the business. The ideal candidate will have a strong understanding of the principles of continuous improvement, lean six sigma techniques, manufacturing processes, and data analysis. The Continuous Improvement Engineer I will also provide excellent organizational, communication and leadership skills to manage projects, develop processes, and highlight opportunities.
Essential Duties and Responsibilities:
Measure and analyze performance metrics of the production and support operations and spearhead initiatives to decrease variation and waste.
Acts as the primary point of contact for continuous improvement in manufacturing
Participates in cross-functional Lean Six Sigma process improvement teams using the DMAIC method.
Prepare process flow maps and value stream maps of operational processes to identify gaps and opportunities.
Identify best practices and deploy them across the business.
Develop new and innovative ways to collect, track, and visualize data.
Create dashboards and other communication tools to drive alignment across the business
Prepare SOPs, line layouts, production line diagrams as needed.
Write and modify SOPs relating to the production area and assist in training of affected personnel.
Prepare reports to recommend action based on data.
Participate in risk assessment activities e.g., FMEA to identify and mitigate process risks
Applies sound engineering principles to improve existing equipment and processes by reducing waste, increasing throughput, reducing energy consumption, or eliminating human interaction through automation.
Participate in problem-solving and root-cause analysis sessions to drive rapid resolution of safety, quality, or performance events; develop and/or lead actions that will prevent reoccurrence.
Stay updated on industry trends in continuous improvement and apply them to enhance operations.
Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
Attendance at work is an essential function of this position.
Performs other duties as assigned by Manager/Supervisor.
Qualifications:
Required:
Bachelor's degree in engineering (Industrial, Mechanical, Electrical) or in a related field of study.
2-4 years related experience and/or training.
Demonstrated leadership skills with ability to drive personal accountability within teams
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.
High Standard of Report Writing
Experience in a GMP and/or pharmaceutical environment.
Preferred:
Six Sigma Green Belt certification.
Ability to display excellent time management skills.
Ability to effectively present information to various people as the job requires.
Ability to display original thinking and creativity.
Ability to set and achieve challenging goals.
Travel as required
#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.
Auto-ApplyClinical Regulatory Affairs Specialist 2
PCI Pharma Services job in Philadelphia, PA
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-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
Mechanical Supervisor
PCI Pharma Services job in Philadelphia, PA
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 hours for this position are 8am to 8pm Friday through Sunday.***
+ Supervise all mechanical personnel and to assist and train as required. Manage the manpower to ensure adherence to schedule and the meeting of deadlines.
+ Coordinate equipment set ups, repairs and installation to meet customer requirements.
+ Assure compliance to GMP's, SOP's, FDA, DEA and OSHA rules and regulations.
+ Interact with all customers and management to achieve objectives.
+ Able to balance multiple issues simultaneously in a fast pace environment
+ Coordinate resources with requirements that are driven by the production schedule.
+ Instruct mechanics on their job assignments and their priorities.
+ Update mechanics assignments as required by production needs.
+ Schedule overtime as required by production needs while working within Union guidelines.
+ Train, assist and coach employees as needed.
+ Follow up on production complaints.
+ Coordinate lines setup, equipment repairs and preventive maintenance requirements.
+ Maintain spare parts inventory and order supplies as needed.
+ Insure that safety guidelines are followed.
+ Support and assist all mechanical activities.
+ Provide leadership and direction to mechanical employees.
+ Perform payroll activities on a daily basis for the mechanical staff.
+ Perform activities related to investigations
+ Update JDE with daily work hours
+ Performs other duties as assigned by Manager/Supervisor.
+ This position requires extra hours 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
**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.
+ 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 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 or GED
+ Trade or technical school training 2 years in mechanics, electrical, pneumatics, PLC, computer
+ Basic Mathematical Skills
+ Advanced Computer Skills: Ability to perform the most complex computer tasks and operate 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.
+ 10 years' experience in Pharmaceuticals packaging
+ **Preferred:**
+ Knowledge of GMPs, cGMPs, Safety regulations
+ Ability to troubleshoot and repair both major and minor pieces of packaging equipment using problem-solving techniques.
+ Working knowledge of shop practices and hand tools
+ Experience in troubleshooting electrical, pneumatic, and mechanical or PLCs as needed.
+ Must be dependable and show initiative.
+ Must be willing to work overtime.
+ Needs good problem solving skills, should be detail oriented and well organized.
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._
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 Coordinator
PCI Pharma Services job in Philadelphia, PA
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:
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:
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.
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 completed orders and orders in process to ensure compliance with cGMP's and customer requirements.
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.
Prepares planned deviation requests when needed.
Adherence to PCI and cGMP policies, procedures, rules and regulations.
Attendance to work is an essential function of this job.
May perform duties of Quality Auditor as assigned by Supervisor/Manager.
Other duties as assigned by Supervisor/Manager.
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. Must be physically capable of performing the duties below with or without reasonable accommodation, which may be made to enable individuals with disabilities to perform
the essential functions. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, and color vision.
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 noise level in the work environment is usually moderate.
QUALIFICATIONS:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION AND/OR EXPERIENCE:
High school education and experience working in a cGMP environment.
A college degree with a concentration in a scientific discipline is preferred.
Possesses excellent organizational, time management and multi-tasking skills in order to meet commitments and deadlines.
The candidate must be able to demonstrate basic proficiency with personal computers, business software (e.g., MS Office) and technical software (e.g., Mastercontrol).
Ability to create, use and interpret scientific tables, charts, and graphs. Any Lean Six Sigma or process improvement training is a plus.
LANGUAGE SKILLS:
Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to effectively present information to management, and customers.
Must have strong interpersonal and excellent communication skills.
MATHEMATICAL SKILLS:
Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane
and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and
proportions to practical situations.
REASONING ABILITY:
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
COMPUTER SKILLS:
Must have excellent computer skills including Microsoft Word, Excel, PowerPoint, Outlook, and Project.
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.
#LI-DT1
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-ApplyDirector, Data Engineering
PCI Pharma Services job in Philadelphia, PA
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
As a hand-on leader & contributor to PCI Pharma Services' digital transformation, this role is responsible for leading the design, development and maintenance of robust data engineering solutions that enable real-time analytics, operational efficiency, and scalable innovation across the pharmaceutical product lifecycle. By building and optimizing data pipelines, platforms, and governance frameworks, this position supports PCI's mission to accelerate the delivery of life-changing therapies. The role aligns with PCI's commitment to excellence in clinical and commercial services, leveraging data as a strategic asset to enhance decision-making, ensure compliance, and drive continuous improvement across global operations.
Responsibilities:
Design, build, and maintain scalable, reliable and cost-efficient data pipelines to support analytics, machine learning, and operational use cases.
Lead data engineering initiatives that support AI/ML model development, deployment, and scalability across enterprise platforms in alignment with business priorities.
Manage and optimize data ingestion, transformation, and storage processes across structured and unstructured data sources ensuring high data availability and performance.
Administer and maintain data tools and platforms (e.g., Databricks, Airflow, dbt, Kafka) to ensure high availability and performance.
Collaborate with a data platform partner or vendor to implement, integrate, and evolve platform capabilities aligned with business needs.
Execute against the company's data strategy by translating strategic goals into technical roadmaps and deliverables.
Ensure data quality, integrity, and consistency through robust validation, monitoring, and alerting mechanisms.
Implement and enforce data governance, security, and compliance standards in collaboration with relevant stakeholders.
Work closely with data resources and business teams to understand data requirements and deliver fit-for-purpose solutions that meet defined SLAs.
Manage and mentor junior data resources and other technical resources, fostering a culture of learning, accountability and excellence.
Monitor and optimize data infrastructure costs, performance, and scalability in cloud and hybrid environments.
Develop and maintain documentation for data architecture, pipelines, and processes to support transparency and knowledge sharing.
Participate in code reviews, architecture discussions, and agile ceremonies to ensure high-quality engineering practices.
Evaluate and recommend new tools, frameworks, and technologies to improve the data engineering ecosystem.
Support incident response and troubleshooting for data-related issues, ensuring timely resolution and root cause analysis.
Work within approved CI/CD procedures to ensure consistent, secure, and automated deployment of data engineering solutions.
Drive automation and standardization across data workflows to improve efficiency and reduce manual effort.
Completes all job duties in compliance with company policy, SOP's, safety rules, along with all federal, state, and local regulations, including OSHA, FDA, cGMP standards and employment law.
This position may require overtime and/or weekend work.
Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
Attendance of work is an essential function of this position.
Performs other duties as assigned by Manager/Supervisor.
Required:
Experience with modern data platforms and tools (e.g., Databricks, Snowflake, BigQuery, dbt, Airflow, Spark).
Strong understanding of data modeling, ETL/ELT processes, and data warehousing best practices.
Familiarity with CI/CD tools and practices (e.g., GitHub Actions, Jenkins, Terraform).
Experience working in cloud environments (AWS or Azure).
Proficiency in SQL and at least one programming language (e.g., Python, Scala).
Bachelor's Degree in a related field and/or 5-7 years related experience and/or training.
College Level Mathematical Skills
Advanced Computer Skills: Ability to perform the most complex computer tasks and operate 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:
Experience working with data platform vendors or managed services.
Knowledge of data governance frameworks and compliance standards.
Exposure to data mesh or domain-oriented data architecture.
Experience mentoring or leading junior engineers.
Prior experience in a regulated environment, particularly in the pharmaceutical sector.
#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-ApplyPackaging Development Intern
PCI Pharma Services job in Philadelphia, PA
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:
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.
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**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.
Ø Work is primarily performed at a desk and/or in an office environment. for up to 1/4 of the day.
Ø 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:**
+ Familiarity and knowledge of paperboard, corrugated, plastics and flexible films.
- 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
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
PHL_Engineering Technician
PCI Pharma Services job in Philadelphia, PA
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:
All activities are focused around technical and operational support to the production, maintenance, and support staffs in the areas of process improvement, equipment modification and optimization, safety and quality improvement, and increasing throughput. This is achieved through individual effort and participation of teams, tracking and analysis metrics, a basic understanding and utilization of good engineering practices, and the use of Lean Six Sigma techniques. Additional responsibilities include supporting the Business Units and plant Operations with serialization tasks and systems.
**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.
+ For assigned equipment projects, take the primary responsibility for the installation, setup and testing of packaging equipment including but not limited to the following:
+ Moving and placing equipment
+ Connecting mechanically and/or electrically
+ Setting and Testing equipment
+ Building programs/recipes
+ Vendor management
+ Cross functional collaboration
+ Customer interaction
+ Equipment Safety
+ Equipment Reliability
+ Equipment Performance
+ Lead the field activities for Process Line Trials (PLT's) and Engineering trials of packaging equipment related topics.
+ Mechanical equipment
+ Electrical equipment
+ Control instrumentation
+ Troubleshooting
+ Provide expertise and training to the Mechanical team for packaging equipment related topics as the equipment Subject Matter Expert (SME)
+ Conducts and/or participates in customer meetings and attends occasional off-site meetings. Interacts with Sales and customers to determine requirements for new products/orders.
+ Participates in internal review meetings to plan new jobs with plant Operations, Maintenance, Quality, Purchasing and Process Engineering.
+ Prepares Standard Operating Procedures (SOPs), line layouts, production line diagrams as needed.
+ Assist with Factory & Site Acceptance Testing (FAT/SAT) for all assigned projects.
+ Develop design criteria and equipment specifications, including safety, regulatory and necessary performance criteria.
+ Responsible for determining Operational Qualification (OQ) parameters to start validation.
+ Coordination of outside design, integration, and equipment manufacturing services.
+ Assist Validation with OQ and Process Qualifications (PQ) of new packaging business.
+ Write and modify SOPs relating to the production area and assist in training of affected personnel.
+ Assists with Corrective And Preventative Actions (CAPA) investigations and actions. Initiate investigation activity and troubleshoot problems in packaging; discovers causes of non-conformance, i.e., slow throughput, poor quality and/or unsafe design.
+ Applies sound engineering principles to improve existing equipment, packaging design and processes by reducing waste, increasing throughput, reducing energy consumption or eliminating human interaction through automation.
+ Measure and analyze performance metrics of the production area and spearhead initiatives to decrease variability and waste.
+ Creates and modifies Antares recipes for products run on lines with Antares Tracking System.
+ Maintains and operates the Antares Warehouse Tracking System (WTS) process.
SUPERVISORY RESPONSIBILITIES:
+ No supervisory responsibilities.
**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.
Office and Production floor 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.
**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.
+ Associate or technical degree in mechanical science, electrical science or instrumentation control, or minimum of 5-8 years of experience with automated packaging equipment.
+ Minimum of 3 years of relevant experience in a Lean and/or Six Sigma environment.
+ Minimum of 5-8 years of relevant experience with packaging equipment.
+ Lean Six Sigma Background preferred.
+ Pharmaceutical and/or food packaging background preferred.
\#LI-DT1
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