Pci jobs in Rockford, IL

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Responsibilities: * Effectively working with the team to prioritize work and establish a strong partnership with HR to ensure clear governance in how value is delivered to the end users with the goal of providing an amazing employee experience. * Demonstrate ability to provide Tier 1 & Tier 2 user support, troubleshooting, and education to HRIS users, primarily HR team members. * Partners with HR team members in business process enhancements. Assist in the review, testing and implementation of upgrades or patches. * Support in the maintenance and updating of the HRIS database, including employee records, organizational structures, job profiles, and other relevant data. * Serve as a primary point of contact for HRIS related inquiries by way of the internal ticketing system and appropriately assign tickets to WD support team members. * Partner with cross-functional team members and HR on HRIS-related issues/enhancements/queries. * Participate and contribute to the pro-active review and implementation of process improvements to ensure enhancement of user experience and improve data management. * Communicate and partner with key external vendors as needed. * Generate standard and ad-hoc reports, dashboards, and analytics to support HR and business decision-making. Assist in developing and maintaining regular reporting processes to provide timely and accurate data to stakeholders. * Assure data integrity of internal HR systems and databases; monitor system access and user permissions to safeguard sensitive HR data. * Provide ad-hoc operational support, special programs and initiatives as needed. Qualifications: * Bachelor's degree in human resources, information technology, or a related field. * 7+ years of experience with Workday HR information systems (HRIS), including configuration, reporting, and data management. * Workday configuration experience in one or more HR modules: Recruiting, Benefits, Performance, Comp, Payroll, Absence, or Time Tracking. * In depth knowledge & experience with Payroll, Absence, or Time preferred. * Working knowledge of the interdependencies of Workday modules and an awareness of potential downstream impacts of any configuration changes. * Workday Reporting or Integrations experience a plus. * Able to modify/update Workday business processes, eligibility rules, and condition rules. * Ability to navigate stakeholder relationships and accurately gather their requirements. * Effective communication in translating technical information into clear, user-friendly communications for HR and other business partners. * Ability to troubleshoot issues and propose practical solutions. * Adaptable and able to pivot quickly to changing requirements and business needs. #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.

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: Supervisor, Comm. Production Location: Assembly Drive, Rockford, IL 61109 Shift: 3rd Shift - Monday - Thursday 9pm - 7am Summary of Objective: The Production Supervisor is responsible for the safety, quality, and operational excellence for their shift and value stream. In this role they direct and coordinates daily, weekly and monthly objectives and activities for their value stream. Manage the overall workflow by assigning responsibilities to direct reports for the production floor to ensure right first time and on time delivery to our customers. 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. * Direct the daily activities of the production floor, on their shift, in compliance with company policies and procedures, along with all federal, state and local regulations, including OSHA, FDA, cGMP standards and employment law. Responsible for the Safety culture and results on the production floor, own and drive safety improvements within your value stream. * Ensure all safety incidents on their shift are investigated, root cause determined, and corrective actions identified and implemented to mitigate future risk. Communicate operational challenges and execute your course corrections with regard to Safety, Quality, Service, Cost, or Personnel. * Facilitate the line/shift handoff prior to departure every day. Plan and execute activities with procurement, maintenance, warehouse and quality departments through active communications to achieve and sustain results. * Understand operating challenges and utilize problem solving tools to drive continuous improvement opportunities for your value stream. * Manage daily schedule to ensure proper staffing levels to include periods of vacations and holidays to meet required service levels. * Oversee and participate in the interview/selection process of hiring. * Educate and train staff using TWI methodology to ensure adherence to performance expectations as defined in current best practice documentation. Perform associate evaluations through Quantum, providing feedback and development as needed. * Own and actively drive KPI'S for your value stream through visual control boards and line communications. * Analyze performance of equipment, personnel and shift for improvement opportunities, develop plans and execute projects to improve the process. * May require use of Personal Protective Equipment (PPE) and Powered Air Purifying Respirator (PAPR). * Manages time and attendance daily and approval of payroll. * This position may require overtime and/or weekend work. * Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules. * Attendance to work is an essential function of this position Performs other duties as assigned by Manager/Supervisor. Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Required: * Associate's Degree in a related field and/or 1-3 years related experience and/or training. * 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. * History of successful supervisory responsibilities. Preferred: * Ability to identify and resolve problems in a timely manner. * Ability to effectively present information to various people as the job requires. * Ability to set and achieve challenging goals. * Bachelor's Degree For Illinois residents: the hiring rate for this position is $62,960 -$70,830 plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k). #LI-KH1 Join us and be part of building the bridge between life changing therapies and patients. Let's talk future Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Main purpose of role: The purpose of this role is to transform sites and establish a sustainable Lean culture by driving the elimination of waste and enabling the flow of value to the internal and external customer. The CI Manager will demonstrate accountability for the deployment of Lean Thinking across the site, ensuring alignment with the Site Strategy and Global Operational Excellence. Manage a team of 5-8 CI professionals to drive improvement over 1MM square feet of a Pharma Packaging and Device Assembly facility that runs 24 /7. Main responsibilities: * Create, in conjunction with the Global OPEX Director and Site GM, the lean vision for the site and facilitate the implementation of the Lean Maturity Index to establish an Operational Centre of excellence. * Define weekly goals for the CI team that align with the site's yearly CI goals. Develop and use a project hopper that organizes site priority, gives feedback to the customer, and tracks CI savings. * Facilitate and coach CI Engineers to use tools like A3, cross-functional Kaizen events, lean training, KATA events, and other CI tools to drive best practice in process improvement. * Lead Business Critical Improvement Projects and the associated teams, as directed by the General Manager and SLT. * Represent the Site by engaging with the Director of Global Operational Excellence, ensuring global standards are deployed (Lean Maturity Index), site best practice shared, and results communicated. * Use margin and cost-based analysis to identify opportunities to implement improvement activities to increase profitability, setting yearly savings goals for each CI team member. * Maintain and report Site cost-saving data in support of the Business Cost Reduction Targets. * Lead, mentor, and train the Site Team to raise Lean Awareness, develop the Lean Approach and build in Lean Capability across all functions. * Be part of the Site Senior Management team, supporting alignment to site strategy across all departments, challenging non-value adding activity and facilitating Lean Leadership. Work Experience and Skills Required * Experience of leading teams in the Pharmaceutical and/or Medical Device industry (other highly regulated and quality-driven industries may be considered) * Able to demonstrate application of continuous improvement tools and techniques (Kaizen, TPM, SMED, RCA, 5S) to deliver positive outcomes. * Strong interpersonal skills must be driven to develop relationships with Site Leaders, SMEs, and Direct Labor Work Force. * Dynamic and ambitious professional with a proven delivery record. * Strong team player able to demonstrate an ability to lead and facilitate informal and formal teams in the development and delivery of improvement solutions. * Able to work across the operational organizational environment and is driven to find solutions to opportunities. * Must be able to work under pressure and coordinate multiple activities concurrently. * Hands-on approach to problem solving and mindset, organized and methodical. * Demonstrated ability to extract critical information to enable effective and appropriate decision making. * Strong understanding of stakeholder management tools to ensure engagement in change at all levels. * Willing to learn and develop skills and knowledge. * People Management. * Experience of managing finances and tracking of cost savings. Qualifications: * Lean Black Belt 'Certified' with tenure in the role using this methodology. * Leadership training and experience. * Education, preferably a degree, in Process Engineering, or other CI related degrees. * Quality Engineering education and experience. Regulatory/Industry Responsibilities: Preferred: * Quality Engineering education and experience. The hiring rate for this position is $97,280-$109,440 plus eligibility 10% MPB for an annual performance bonus. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), a flexible spending account, and a 401(k) plan. #LI-SW1 Join us and be part of building the bridge between life changing therapies and patients. Let's talk future Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Position Title: Quality Control Coordinator Location: Assembly Drive, Rockford, IL 61109 Shift: 1st Shift SUMMARY The Quality Coordinator assists with coordinating quality activities to ensure that goals and objectives of the team are accomplished within prescribed time frames. Helps drive project success to provide PCI a competitive advantage in long-term quality customer management. Essential Duties and Responsibilities: * Prepares and distributes required documentation for requested production work orders. * Perform documentation review of completed orders to ensure compliance with cGMP's and customer requirements. * Reviews and interprets customer standards, procedures, and specifications for dissemination relative to batch records, forms and material specifications. * Prepares customer required samples for shipment according to approved shipping instructions. * Prepares and submits batch records, accountability reports and necessary documentation to customers to facilitate product release. * Organize internal and customer approval of batch records and specs. * Perform record reviews of both completed and in-process orders to ensure compliance with cGMP's and customer requirements. * Perform Line Clearance inspections of equipment and production suites. * Help identify, communicate, track and resolve document related issues with other departments and customers. * Function as one of the customer points for comments or questions pertaining to batch records. * Initiating supplier non-conformance reports and effectuates material control. * Reviews and integrates planned deviation requests into batch records when needed. * Adherence to PCI and cGMP policies, procedures, rules and regulations. * Attendance to work is an essential function of this job. * May perform label creation duties including generating computerized labels. * May perform duties of Quality Auditor as assigned by Supervisor/Manager. * Other duties as assigned by Supervisor/Manager. * Shift is Monday through Friday 8:00 am to 5:00 pm. Qualifications: Required: * High School Diploma or GED * 1-3 years related experience and/or training. * Basic Mathematical Skills * Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs. * Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs. * Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables. * High Standard of Report Writing Preferred: * Ability to follow instructions and respond to management direction. * Ability to work independently and/or part of a team. * Ability to display excellent time management skills. * Ability to demonstrate attention to detail. * A college degree with a concentration in a scientific discipline is preferred. * The candidate must be able to demonstrate basic proficiency with computers, business software (e.g. MS Office) and technical software (e.g. Master Control). Ability to create, use and interpret scientific tables, charts, and graphs. Any Lean Six Sigma or process improvement training is a plus. For Illinois residents: the hiring rate for this position is $18.15 to $20.42 hourly plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k). Equal Opportunity Employer/Vet/Disabled Join us and be part of building the bridge between life changing therapies and patients. Let's talk future Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

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. Weekend B: Friday, Saturday and Sunday ( 7:00pm-7:00 am) Includes an additional 24% shift premium. Summary of Objective: The Instrument Control and Vision Technician's duties include setting-up, installing, troubleshooting, maintaining and repairing equipment while following all work practices and procedures. Technicians will maintain a safe work environment, while supporting the internal/external customers and site goals and objectives. This is an entry level position into I.C.&V, the ideal candidate will be required to understand and perform the basic vision set-ups and basic troubleshooting along with the basic comprehension of electrical troubleshooting. 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. Knowledge of electrical devices in AC/DC control circuits (e.g., switches, relays, indicators, motor starters, overloads, contactors, fuses). This includes knowledge of types of devices, limits, and functions. PLC Programming: Knowledge of and the ability to read and write programmable logic code for PLCs. Vision-Systems: Knowledge of machine vision systems, including the ability of program code-reading systems. Servo Drives: The ability to understand the functionality of servo-drives. The ability to read, interpret and use the information presented in drawings, diagrams, schematics and blueprints to determine appropriate activities, tools and next steps in the production process or systems being used; and keeping licensing up to date. Electrical Systems: Knowledge of 3-phase electrical systems, including components, repair processes, and installation procedures. Preventative Maintenance: The ability to identify equipment maintenance needs by using PM Work Orders. This includes the ability to communicate these needs to the appropriate people. Pneumatic Components and Diagrams: Knowledge of pneumatic systems and diagrams. This includes knowledge of functions, components, and safety procedures. Lockout/Tagout (LOTO) Procedures: Knowledge of the processes and procedures to lock out equipment while cleaning, repairing or servicing. Production Processes: Basic knowledge and development of plant production processes and layouts, which includes cross-departmental coordination, communication, and planning within our area of responsibility. Power Tools: The ability to properly and safely operate, maintain, repair, clean, and store power tools and equipment (e.g., chop-saw, hand drills). Manual Dexterity: The ability to quickly move your hands, your hands together with your arm, or your two hands to grasp, manipulate, or assemble objects. Hand-eye Coordination: The ability to coordinate one's eyes with one's fingers, wrists, or arms to move, carry, or manipulate objects or to perform other job-related tasks. Visual Acuity: The ability to see details (e.g., letters, numbers, codes, color, symbols, marks, labels, signs) clearly, to accomplish work tasks in a safe and efficient manner. This position may require overtime and/or weekend work. Collaborate with the Maintenance Mechanics in problem solving and equipment set-up. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules. Attendance to work is an essential function of this position. Performs other duties as assigned by Manager/Supervisor. Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. Required: * Skills testing requirements met at approved grade level for position. * Associate's Degree in a related field and/or 1-3 years related experience and/or training. * PLC (Programmable Logic Controller) experience * Machine Electrical troubling experience * Basic Mathematical Skills * Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs. * Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs. * Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables. * High standard of report writing. Preferred: * Ability to effectively present information to various people as the job requires. * Ability to follow instructions and respond to management direction. * Ability to identify and resolve problems in a timely manner. * Ability to work independently and/or as part of a team. * Ability to display excellent time management skills. * Ability to display a willingness to make decisions. * Ability to display original thinking and creativity. * Ability to hold oneself in a professional manner. * Ability to adapt to changing work environments. * Ability to set and achieve challenging goals. * Ability to exhibit sound and accurate judgment. * Ability to demonstrate attention to detail. * The hiring rate for this position is $24.58-$27.65 per hour plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), a flexible spending account, and a 401(k) plan.* #LI-SW1 Join us and be part of building the bridge between life changing therapies and patients. Let's talk future Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Position Title: Security Specialist Location: Assembly Drive, Rockford, IL 61109 Department: Security Shift: 24/7 AM Shift (Weekend) Reporting To: Supervisor, Security Responsible For (Staff): None Job Summary PCI is seeking a Security Specialist who will play a crucial role in safeguarding our facilities, data, and intellectual property. The successful candidate will be responsible for conducting thorough risk assessments to identify potential security threats and vulnerabilities, developing and implementing robust security protocols to protect against unauthorized access, data breaches, and other security incidents, and utilizing advanced monitoring and surveillance systems to ensure the safety and security of our premises and assets. Additionally, the Security Specialist will lead incident response efforts, including investigations, documentation, and resolution of security breaches, ensure compliance with industry standards, regulations, and best practices related to security and data protection. Provide training and awareness programs to employees on security policies and procedures. The ideal candidate will have a strong background in security management, excellent analytical skills, and the ability to work collaboratively with cross-functional teams. Experience in the pharmaceutical or biotechnology industry is a plus. Essential Duties and Responsibilities: * Ensure the protection and safeguarding of company assets, personnel, visitors, and sensitive materials through proactive security measures and situational awareness. * Conduct thorough investigations into security incidents, breaches, and other matters requiring detailed analysis. * Collect and document statements from witnesses, victims, and suspects in a clear and concise manner. * Perform comprehensive foot patrols, verifying the integrity of security measures and submitting thorough documentation of observations. * Monitor and assess activity in parking areas, employee access points, and high-traffic zones, maintaining vigilance during shift changes and peak operational hours. * Conduct scheduled and random security inspections, documenting findings in detailed security reports and escalating concerns as necessary. * Enforce security protocols by issuing citations for violations in accordance with established policies and procedures. * Respond promptly to environmental, fire, and security alarms, following the established call-out matrix and emergency response protocols. * Monitor and manage surveillance systems, identifying and reporting suspicious behavior or security breaches. * Maintain and manage access control systems, including issuing ID badges and access cards to employees, contractors, and vendors, ensuring compliance with badge policies. * Serve as a key member of the Medical Emergency Response Team (MERT), providing support during medical incidents. * Activate and deactivate alarm systems as required for operational security. * Secure facility entrances and exits by locking/unlocking designated access points per schedule. * Assist in the development and revision of security-related policies and standard operating procedures. * Maintain accurate inspection logs and incident records, advising management on deficiencies and recommending corrective actions. * Prepare and process personnel security clearance requests and maintain associated documentation. * Provide professional assistance to employees, visitors, and vendors while upholding departmental protocols. * Under the direction of the Director of Security or Security Manager, mentor, train, and supervise a team of approximately twelve contract security officers, leveraging prior military/law enforcement leadership experience. · Flexibility to work overtime and weekends as required by operational needs. · Maintain reliable attendance and punctuality as a critical function of the role. · Maintain strict adherence to all PCI, cGMP, and GCP policies, procedures, and regulatory requirements. Qualifications: Required: * Associate's degree in a related field preferred and/or 3-5 years of relevant experience in security operations, investigations, or a related field. * Previous experience in law enforcement, corrections, or military service. * A valid driver's license is required. * Strong investigative skills with the ability to analyze complex situations. * Excellent communication skills, both written and verbal. * Proficiency in conducting interviews and collecting statements. * Experience in providing de-escalation training. * Basic Mathematical Skills · Intermediate Computer Skills: Ability to perform more complex computer tasks and have knowledge of various computer programs. · Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs. * High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms. * Driver's License Preferred * Knowledge of security systems and technologies. Good working knowledge of security operations, safety practices in a business environment and enforcement procedures. · Familiarity with legal and regulatory requirements related to security. Ability to effectively present information to various people as the job requires. Ability to identify and resolve problems in a timely manner. Ability to hold oneself in a professional manner. Ability to demonstrate attention to detail. * Military or police background * Must be able to perform work both inside and outside the property with exposure to inclement weather and unpredictable crisis situations. For candidates in Illinois: The hiring rate for this position is $22.15 to $25.00 hourly plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), a flexible spending account, and 401(k). #LI-KHI 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.

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: Cleaning Specialist Location: Assembly Shift: 1st Shift Summary of Objective: Dedicated and detail-oriented Cleaning Specialist to join our team. In this role, you will be responsible for ensuring the cleanliness and sterilization of our production equipment tooling; ensuring functionality of our machinery and adherence to the production schedule, which is crucial for maintaining optimal production efficiency. Your work will play a vital role in supporting our commitment to quality and safety standards. 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 are the following but other duties may be assigned. * Perform thorough cleaning and sanitization of all production equipment tooling, including the disassembly and reassembly of product contact and non-product contact parts as specified by cleaning protocols. * Follow established cleaning procedures for all production equipment tooling to prevent cross-contamination and ensure compliance with hygiene standards. Follow established policies, procedures, and safety regulations without deviation. * Follow strict safety guidelines, wearing appropriate Personal Protective Equipment (PPE). * Safely and effectively use appropriate cleaning agents and chemicals, following specific mixing and usage guidelines. * Mix and prepare cleaning solutions according to safety guidelines. * Use and dispose of cleaning chemicals and other hazardous materials safely and responsibly, in accordance with safety data sheets (SDS). * Visually inspect cleaned tooling/equipment to ensure the production equipment tooling is free of product debris or residue from previous production run prior to releasing. Inspect tooling/equipment to identify potential quality issues, damage, or areas needing attention or immediate repair. * Wrap and secure tooling/equipment to maintain 60-day sanitization period while being transported and stored. * Maintain accurate records of cleaning activities to support operational transparency. * Maintain clean room sanitization through daily, weekly, monthly, and annual cleaning process routines. * Monitor and replenishes clean room inventory and coordinates inventory order requests with the lead/supervisor. * Ensure compliance with cGMP, corporate standards/PCI Quality System (PQS), site policies/procedures, regulatory requirements, and industry standards. Communicate regularly and effectively. Work cross functionally to ensure communication within the business is always up-to-date and utilizes all available channels. * Effective communication skills to coordinate with team members and report issues to supervisors. * Maintains attention to detail and quality while completing multiple or repetitive tasks and meeting product timelines. * Partner with the PCI Validations department to prepare, execute, and close out validation documentation for tooling and process validation. * Partner with Quality Systems to issue and reconcile PCI functional department logbooks. (Production, Maintenance, Quality). * Perform documentation and records review of completed logbooks to ensure compliance with cGMP's and customer requirements. * Ensure all documentation aligns with quality standards, regulatory requirements, and company policies. * Strong understanding of quality assurance principles and regulatory practices is essential for this role. * Use and effectively navigate PCI EDMS to obtain controlled documents and training relating to job role. * Reads, understands and communicates information contained in controlled documents. * Complete and attend required annual bloodborne pathogen training to stay informed about dangers and safe procedures. * Responsible for the safe and thorough cleaning, disinfection, and removal of blood and other potentially infectious materials (OPIM) from a variety of settings. * Participate in all required PAPR training sessions, medical evaluations, and fit testing to ensure competence and proper function of the equipment. * Follow all required safety protocols, including wearing a PAPR in designated areas or during specific tasks that pose a respiratory hazard. * The skill to prioritize tasks and work efficiently to meet deadlines. * The capacity to work effectively with minimal supervision. * Attendance at work is an essential function of this position. * This position may require overtime and/or weekend work. * Performs other duties as assigned by Manager/Supervisor. Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Required: * Skills testing requirements met at approved grade level for position. * Basic Mathematical Skills * Familiarity with cleaning agents and safety protocols. * 1-2 years of experience in Quality and/or providing support in a manufacturing environment. * Strong attention to detail and ability to follow instructions accurately. * Ability to adapt to changing priorities and work efficiently in a fast-paced setting. * Minimum Professional Proficiency: Ability to speak in a way that allows one to participate effectively in various conversations. Ability to read various types of standard items addressed to general readers. * Intermediate Reasoning: Ability to apply common sense understanding to carry out instructions that may be furnished in written, oral, or diagram form. Ability to deal with problems that involve several concrete variables in standardized situations. Preferred: * Ability to work independently and/or as part of a team. * Proven experience in a manufacturing or industrial clean room. * Proven experience in a quality role, preferably in a manufacturing or industrial environment. * Ability to follow instructions and respond to management direction. * Ability to display a willingness to make decisions. * Ability to display excellent time management skills. * Strong work ethic and commitment to maintaining a clean and safe work environment The hiring rate for this position is $19.96 - $22.45/hour plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k). #LI-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.

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: Maintenance Mechanic 2 Location: Assembly Drive, Rockford, IL 61109 Shift: Weekend B (Fri, Sat, & Sunday; 6:45pm - 7:00am) Shift Premium: 24% The Maintenance Mechanic's duties include installing, troubleshooting, maintaining, and repairing equipment while following all work practices and procedures. Mechanics will ensure and help maintain a safe work environment, while supporting the internal customer to achieve the sites business goals and objectives. ESSENTIAL DUTIES AND RESPONSIBILITIES: * Support the packaging lines by making routine and non-routine adjustments that ensures a high-quality product. * Collaborate with other departments and other Maintenance Mechanics to obtain information or experience to keep lines running at an efficient rate. * Perform preventive maintenance, changeovers, repairs, and running adjustments. * Systematically gather information from a variety of sources, analyze the information, identify implications of data, draw appropriate conclusions, generate viable, alternative solutions to a question or problem, and evaluate the consequences of choosing each alternative. * Assert personal ideas and opinions to convince others. This includes gaining others support through one's own actions, examples, or persuasion in an ethical manner. * Define, diagnoses, and resolve problems. This includes seeking, logically examining, and interpreting information from different sources to determine a problem's cause and developing a course of action to resolve the problem and to prevent its recurrence. * Provide guidance to others by responding to questions; observing work activity; giving direction when necessary; and providing on-the-job training. * Use a variety of hand tools and power tools to perform specific duties. * Detect faulty operations, defective material, and report those and any unusual situation to proper personal. * Read and interpret equipment manuals and work orders to perform required maintenance and services. * May require overtime and/or weekend work. * May require the use of Personal Protective Equipment (PPE) and Powered Air Purifying Respirator (PAPR). * Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, and rules. * Prompt escalation to the supervisor of any safety issue, quality issue, or downtime following the established escalation protocol. * Perform Single Minute Exchange of Dies, (SMED) activities on packaging lines * Execute initiatives relating to OPEX objectives. * Analyze equipment failures to improve overall reliability of the equipment, while maintaining productivity. * Update setup documentation to ensure all settings are current and accurate. * Work with The Business Units and Scheduling to accurately maintain a timeline for any launches or validations of products. * Audit and maintain a high level of 5's in the facility to help maintain a safe, organized, clean high-performing workplace. * Document and drive actions for specific respected value streams. * Audit the centerline document system to ensure sustainability and a high level of productivity. * Attend Tier I Daily Directional Setting (DDS) meeting. Give feedback and follow-ups when outages occur from the centerline document. QUALIFICATIONS: Required: * Skill testing requirements met at approved grade level for the position * Must have at least 2-3 years of applicable maintenance experience, preferably in a manufacturing environment or 2-year Technical School. * Basic Mathematical and computer skills. Ability to perform basic computer tasks and can operate common computer programs. * Minimum professional proficiency: Ability to speak in a way that allows one to participate effectively in various conversations. Ability to read various types of standard items addressed to general readers. * High reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. * Ability to interpret a variety of instructions that may be provided in various forms. Preferred: * Ability to identify and resolve problems in a timely manner; work independently and/or as part of a team; hold oneself in a professional manner; demonstrate attention to detail; and drive for results. * Packaging experience The hiring rate for this position is $24.58 to $29.19/hour plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k). Join us and be part of building the bridge between life changing therapies and patients. Let's talk future Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Position Summary This position will direct staff and manage all accounting activities to ensure compliance with generally accepted accounting principles, corporate policies, and external audits. In this position you will be responsible for all accounting functions to include but not limited to payroll, accounts payable, accounts receivable, and the monthly closing and preparation of reports in support of all financial statements. You will report to and work closely with the Executive Finance Director ("EFD"), the corporate accounting function and other stakeholders in the organization. This position requires strategic financial leadership, operational partnership, and compliance oversight in a dynamic, profitable, and growth-oriented environment. Key Responsibilities: * You will be responsible for all aspects of accounting (payroll, accounts payable, accounts receivable, billing, general ledger, fixed assets, audit, etc.). * Direct and supervise a team of people and proactively manage and coach the team providing employee development opportunities. * Manage and deliver timely monthly financial close process, including preparing journal entries, ensuring all costs incurred are properly recorded, perform account balance reconciliations and report preparation. * Oversee variance analysis and review expenses by financial statement line item for reasonability, investigate unusual amounts, make any corrections as necessary, and determine root cause and solutions. * Interact at all levels and with budget owners or other stakeholders to produce timely, efficient and accurate month-end close and all internal management and financial reporting incl. lease accounting. * Participate in the ongoing development & establishment of accounting policies and procedures and operational strategies including the review and implementation of process and system changes. * Drive continuous process improvements leveraging digital technology and support the development and enhancement of the ERP platform (JDE) to ensure systems integrity, financial effectiveness and controls. * Collaborate with external auditors to ensure successful audit results and compliance. * Define and maintain department KPI's. * Ensure compliance with internal control policies. * Assist with compilation of information for preparation of tax returns. * Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules. * Performs other duties and corporate finance projects as assigned by Manager. Knowledge, Skills and Abilities: * Relevant accounting experience in Manufacturing and/or Supply Chain. * Apply GAAP accounting standards related to revenue recognition, lease accounting and asset capitalization. * Experience with accounting software JDE or similar ERP platform is a plus. * Ability to quickly comprehend a complex organizational structure, including the general ledger structure and various financial systems, is essential. * Proven ability to leverage current technology to drive process efficiency and improve accuracy * Advanced analytical skills in combination with excellent written and oral communication skills. * Exceptionally well organized, flexible and easily adaptable to changing conditions. * Ability to work under pressure, meet deadlines and manage conflicting priorities. * Advanced and demonstrated proficiency with Excel. * Self-motivated with the ability to multi-task, work independently and with minimal direction. * High energy, high ownership of work products and dedication and commitment to driving results. * Work on-site in Rockford, IL. * "Roll-up-your-sleeves" attitude. Competencies Required: * Confident, fact-based decision maker. * Pro-active, looking for new solutions, opportunities and insights. * Approaches problems from different perspectives to suggest and implement solutions. * Forecast issues pro-actively to prevent potential impacts; both internally and externally. * Facilitates communication between team members to ensure efforts are aligned. * Takes accountability for delivering on commitments; owns mistakes and uses them as opportunities for learning and development. * Ability to solve complex problems. * Adept at using logic and reasoning to work through problems and analyze information. * Pro-active approach and leadership style. * Holds self and others accountable for specific deliverables and continuously raises the bar in terms of quality of work-product delivered. Minimum Qualifications: * CPA (CA, CMA or CGA) designation with 10+ years related work experience. * Manufacturing experience required. * Pharmaceutical Industry experience preferred. The base salary hiring range for this position is ($122,000-$150,000) plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k). #LI-EK1 Join us and be part of building the bridge between life changing therapies and patients. Let's talk future Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

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: Associate Quality Account Manager Department/Group: Business Unit - QC Location: Assembly Drive Summary of Objective: Assists with coordinating quality activities of a designated Customer Focused Team to ensure that goals and objectives of the team are accomplished within prescribed time frames and in budget. Helps drive project success to provide PCI a competitive advantage in long-term quality customer management. Updates Batch Record Documentation and Material Specifications to ensure compliance standards are met and maintained. Facilitates customer questions for Batch Record review and Documentation Updates. Maintains a positive working relationship with internal and external customers. 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. * Primary reviewer for master batch records, forms and specifications to ensure that the documents meet internal and customer requirements for standards, procedures and requirements. * Assist with creating and updating batch records, forms and material specifications as well as organizing internal and customer approval of batch records and specifications. * Assist with performing record reviews of completed orders and orders in process to ensure compliance with cGMP's and customer requirements. Assist as company liaison with customers concerning quality control documentation. Help identify, communicate, track and resolve document related issues with other departments and customers. * Performs finished product batch release of approved production lots. * Attend conference calls and customer meetings; provide complaint and quality related information. * Assist in the preparation of annual product review data. * Assist with generating and presenting quality related metrics and key performance indicators for team's performance. * Assist with the investigation of Quality deviations and the drafting of investigation reports associated with such deviations. * Assist with addressing and documenting quality events with Production and Quality teams. * Assist with training, developing, and mentoring new Quality Coordinators. 11. 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. * Develop, update and implement procedural changes throughout the organization. * Standardize documentation to ensure PCI's Standard for Quality is achieved throughout our customer base. * Coach, train, mentor and develop PCI's employees to ensure Quality Standards are met and maintained. * Schedule, host and lead meetings to develop, implement and / or update Batch Records, Material Specifications, Forms, Work Practices and Standard Operating Procedures. * Assist with In-Process / Finished Goods Inspections, Annual Retain Inspections, Customer Complaint Samples or Rework as needed to support the various groups throughout PCI. * Compile, update and analyze customer / internal data and metrics to identify potential trends and areas for opportunities. Utilize the Microsoft Office Suite in detail to present data / facts in a professional fashion. * Assist and Support the RIT Investigation process through on-line interactions with the Operations staff. Provide a summary of the findings / investigation to the appropriate Business Unit representative. * Present data to customers / internal management with ease and without undue hardship. * Maintain positive external and internal customer relationships with face-to-face, email and voice communication. Provide the appropriate feedback within 24 hours of notification. * Assist with Supplier Investigations as needed. * Assess and provide detailed reports / summaries on the impact of process changes to PCI management. * Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Required: - * Associate's Degree in a related field and/or 1-3 years related experience and/or training. * College Level Mathematical Skills * Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs. * Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs. High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms. Preferred: * Ability to demonstrate attention to details. * Ability to work independently and/or part of a team. * Ability to hold oneself in a professional manner. * Ability to effectively present information to various people as the job requires. The hiring rate for this position is $51,120.00 - $57,510.00 plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), a flexible spending account, and a 401(k) plan. #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.

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Location: Assembly Drive, Rockford, IL 61109 Shift: 1st Shift Summary of Objective: This position is responsible for the fabrication, modification, repair, and maintenance of precision tools, dies, jigs, fixtures, and machine parts using manual and CNC machinery. Must have the ability to program CNC with offline software. The ideal candidate will have strong experience in machining and toolmaking, and be able to read blueprints, work with tight tolerances and grinding parts as necessary. High understanding of metallurgy. Reverse engineer parts in real time. Manages work order completions, spreadsheets and schedules. 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. * Program and operate manual and CNC machines (mills, lathes. grinders, & etc) * Read, interpret engineering drawings, blueprints , and CAD designs. * Build, repair and maintain stamping dies, molds, fixtures, and custom tools. * Knowledge of how different metals react to various temperatures, pressures, and forces, (metallurgy). * Inspect and measure finished parts to ensure they meet specifications. * The ability to perform routine and predictive maintenance on equipment and machines. * Must work under tight time lines with multiple priorities. * Troubleshoot and make adjustments to dies and tooling for optimal performance. * Work closely with engineers, production staff, maintenance team, * Ensure safety protocols and company procedures are followed * The ability and willingness to take ownership of work activities and ensure that they are completed accurately, efficiently, and in a timely manner. * The ability to work across organizational and functional boundaries to achieve company goals. This includes the ability to build and maintain strong relationships with cross-functional teams and managers * The ability and willingness to generate new ideas to improve work efficiencies, productivity, and customer service. * The ability to perform general machining activities using mills, lathes, drill press, grinders and other machine shop tools. * The ability to read and use micrometers, measuring tools, gauges, indicators and calibration stickers. * Knowledge of CNC programming/machining, including the ability to read, understand, and edit basic programs * General knowledge of machines and equipment functionality, including how and which tools could be used on such equipment machines. This includes the ability to learn new systems quickly, understand how parts relate and how they impact system functionality. * This position may require overtime and/or weekend work. * Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules. * Attendance to work is an essential function of this position * Provide mechanical floor support on installation(s) and project(s) as required. * Performs other duties as assigned by Manager/Supervisor. * Must be able to use Excel and Microsoft Office programs. 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, technical or trade school certification preferred * 5+ years of experience as a machinist or tool and die maker * Proficient in reading mechanical drawings and GD&T * Experience with CNC and manual tools * Familiarity with precision measuring instruments (micrometers, calipers, indicators) * Strong attention to detail * Ability to lift 50 lbs and stand for extended periods Preferred: * Apprenticeship or journeyman certification in tool and die or machining * Experience in a high-volume manufacturing environment * Knowledge of CAD/CAM software (e.g.,FutureCam, MasterCam, SolidWorks) * Ability to work independently and/or part of a team. * Ability to display excellent time management skills. * Ability to adapt to changing work environments. Knowledge of CNC programming/machining, including the ability to read, understand, and edit basic programs.. * The ability to read, interpret and use the information presented in drawings, diagrams, schematics and blueprints to determine appropriate activities, tools and next steps in the production process. The hiring range for this position is $30.26 - $34.05/hour plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k). #LI-MC1 Join us and be part of building the bridge between life changing therapies and patients. Let's talk future Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. The Validation Analyst II is responsible for overall validation project ownership of moderate risk project(s) under mild supervision. Responsible for the generation and execution of validation protocols, assistance in audits, and determination of validation needs. This job has no supervisory responsibilities. Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following, but other duties may be assigned. Performs validation activities to ensure compliance with government and customer requirements. Prepares validation protocols, validation statements, reports, summaries, and master validation plans for new customer/product/system project launch and maintains existing validated processes/programs at multiple sites, as well as organizing and coordinating internal and customer approvals, as needed. Ensures validation documentation completion, accuracy, and closure, including organizing and coordinating multiple approvals as required. Prepares change control and validation history report for audits. Attends conference calls and meetings. Effectively communicates project goals and progress to the Validation Supervisor / Manager. Investigate validation deviations, documenting in formal reports, and ensuring resolution of corrective action to complete the project. Primary contact for quality validation activities and managing expectations. Reviews and interprets standards, procedures, and specifications for dissemination relative to validation protocols. Knowledge of and adherence to all PCI, cGMP, GCP, GAMP, 21CFR, 21CFR Part 11, and Annex 11 policies, procedures, rules, and requirements. Required to complete and pass a "Documentation Boot Camp" course within 6 months. This position may require overtime and/or weekend work. Attendance at work is an essential function of this position. Performs other duties as assigned. "Moderate Risk Projects" are generally defined as projects/customer accounts that have the following. a. Business needs of the customer/project may require additional time commitments. b. Moderate level of uncertainty in managing customer expectations. c.Validation approach with moderately complex requirements in addition to the Validation Plan. d. Established criteria that are subject to some interpretation. After basic training, this position will be required to specialize in 1 or more Validation areas of focus: a. Process/Cleaning Validations b. HVAC/Utility Validations c. Computer Validations Qualifications: The requirements listed below are representative of the knowledge, skills, and/or abilities required for the stated position. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. Required: High School Diploma or GED and/or 3-5 years related experience and/or training. College-Level Mathematical Skills. Intermediate Computer Skills: Ability to perform more complex computer tasks and know various computer programs. Minimum Professional Proficiency: Ability to speak in a way that allows one to participate effectively in various conversations. Ability to read various types of standard items addressed to general readers. Intermediate Reasoning: Ability to apply common-sense understanding to carry out instructions that may be furnished in written, oral, or diagram form. Ability to deal with problems that involve several concrete variables in standardized situations. Preferred: Process/Cleaning Validation Focus: Background in Packaging, Pharmaceutical, Bio-Pharmaceutical, and/or Medical Devices. Must be able to properly gown and work in an active packaging operation. HVAC/Utility Validation Focus: Familiarity with HVAC wiring diagrams, control design, calibration, instrument configuration, and fundamentals of heating, air conditioning, and refrigeration systems. Computer Validation Focus: Associate's Degree in a related field and/or 1-3 years related experience and/or training. Ability to perform complex computer tasks and have some experience with computer systems considered to have an impact on cGMP, cGXP, Annex 11, and PCI guidelines. For candidates in Illinois: The hiring rate for this position is $ $22.15 - $24.92 hourly, plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), a flexible spending account, and a 401(k) #LI-SW1 Join us and be part of building the bridge between life changing therapies and patients. Let's talk future Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

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:Process Reliability Expeditor Department/Group:Maintenance Location:Assembly Summary of Objective: Expedite equipment, tooling, parts, supplies, and documentation to operations while maintaining accurate inventory in the CMMS system. 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. * Stage and inspect all Tooling for delivery and pickup as requested by PRTs. * Pick up and deliver all carts, parts, and hardware needed by PRTs. * Work with the Engineering Department to identify and enter new tooling/parts/locations in the CMMS system. * Work with Engineers on updating the Bill of Materials. Assemble/repair/engrave tooling and equipment. * Deliver Tool Crib parts as needed. * Work with Maintenance personnel/Supervisors to resolve jacket or Tooling issues. * Create POs for Tooling replacement as needed. * Perform cycle counts of Tooling. * Transfer all Tooling to the correct location in the CMMS system * This position may require overtime and/or weekend work. * Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, and rules. * Attendance to work is an essential function of this position. * Performs other duties as assigned by Manager/Supervisor. Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. Required: * Skills testing requirements met at the approved grade level for the position. * Basic Mathematical Skills * Basic Computer Skills: Ability to perform basic computer tasks and has the ability to operate common computer programs. * Minimum Professional Proficiency: Ability to speak in a way that allows one to participate effectively in various conversations. Ability to read various types of standard items addressed to general readers. * Intermediate Reasoning: Ability to apply common sense understanding to carry out instructions that may be furnished in written, oral, or diagram form. Ability to deal with problems that involve several concrete variables in standardized situations. Preferred: * Ability to adapt to changing work environments. * Ability to identify and resolve problems in a timely manner. * 1-year related work experience The hiring rate for this position is $18.15 - $20.42/hour plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k). #LI-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.

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: Assembly Project Engineer Department/Group: Engineering Location: Linden Road 1st shift Summary of Objective: Design packages, processes, and tooling for assembly and packaging pharmaceutical products in a consistent, high-quality package that complies with cGMP's and customer requirements. 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 are the following, but other duties may be assigned. * Quote tooling and processes for existing or new equipment weekly. * Track tooling and equipment project costs versus planned expenditure. * Design assembly and package line layouts for pharmaceutical products weekly. Design/purchase tooling for Assembly and packaging equipment weekly. * Act as technical Subject Matter Expert (SME) to support customer project team meetings weekly. * Write/revise and execute vendor Factory Acceptance tests as required. 3 per year. * Attend Sales meetings weekly. * Develop critical process parameters for assembly and packaging equipment. Interface with material suppliers on process assembly requirements to provide safe and effective assembled and packaged products. * Design and implement parts and processes for line improvements monthly. Provide information on product contact materials and validation support weekly. * Attend and support customer conference calls weekly. * Review and approve batch records for engineering details weekly. * Attendance to work is an essential function of this position. * Other duties as assigned by the supervisor/manager. * Adherence to all PCI and cGMP policies, procedures, rules, and regulations. * This job has no supervisory responsibilities. * This position may require overtime and/or weekend work. * Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, and rules. * Performs other duties as assigned by the Manager/Supervisor. Qualifications: The requirements listed below are representative of the knowledge, skills, and/or abilities required for the stated position. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. Required: * Bachelor's Degree in a related field. Must have a minimum of at least three years of experience in an FDA-regulated industry with a strong preference for medical devices or combination products. * Minimum 3-5 years of related experience and/or training in project and process engineering roles * College-Level Mathematical Skills * Intermediate Computer Skills: Ability to perform more complex computer tasks and knowledge of various computer programs. * Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs. * Intermediate Reasoning: Ability to apply common sense understanding to carry out instructions that may be furnished in written, oral, or diagram form. Ability to deal with problems that involve several concrete variables in standardized situations. Preferred: * Ability to demonstrate attention to detail. * Drug Delivery medical device * Ability to travel. * Ability to work independently and/or as part of a team. * Ability to follow instructions and respond to management direction. * Design in SolidWorks is a major requirement. AutoCAD design work is a plus. * Previous medical device assembly experience * Design of thermoformed or cold-formed blister tooling, pouching tooling, cartoning tooling, and/or bottling tooling is a plus. The hiring rate for this position is $$77,600 -$87,300 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). #LI-SW1 Join us and be part of building the bridge between life changing therapies and patients. Let's talk future Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

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. n Job Description Commercial Associate Project Manager Assists with designated execution of customer projects and ongoing order fulfillment to ensure that objectives are accomplished within prescribed time frame and budget while adhering to applicable pharmaceutical regulations. Supports maintaining exceptional client satisfaction and superior business performance metrics. Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned. * Create and maintain the customer specific production schedule for both long-term forecast and short-term production demands; follow up on the workflow through each step to maintain schedule integrity and communication. Communicate any On-Time Delivery risks. * Ensure accurate forecasts are in place for monthly Material Requirements Planning runs. * Understand and interpret application of purchasing authorization from the supply agreement; Place purchase order requisitions with procurement and work with them to expedite, delay or cancel if necessary; ensure on-time delivery and communicate any issues with on-time delivery. Support fulfillment and application of Material Requirements Planning tools in ERP system though forecast and order management. * Maintain an understanding of the document creation process which includes, but is not limited to, the following: Lot/Expiration form creation, material receipt/release, batch record preparation and ERP work order creation. * Track On-Time Delivery and document creation metrics for the appropriate business units * Manage and monitor purchase order status' within the PCI-Rockford organization to ensure On-Time Delivery metrics are met * Work with the customer to ensure correct components and artwork changes; communicate price variances with management. * Review and approve documentation including specifications and batch records, as required. * Create bill of materials, component item number and ensure overall data entry accuracy and management. * Monitor and facilitate timely Releases of finished goods. Assist in the preparation of shipment documents. * Assist with disposition of Nonconforming materials and Component Variance Notifications. * Order and ensure shipper labels and print mats are ready for maintenance and production requirements * Ensure obsolete materials are dispositioned and invoiced after a component revision or the end of a project. Responsible for ensuring the destruction of obsolete materials & expired materials as well as providing the Certificate of Destruction to the customer (as required). * Work with Incoming Quality Department to ensure timely release of components and bulk. * Allocate and manage lot specific materials to the Work Order. * Maintain optimal component inventory level for customer owned inventory. Provide continuous support to Project Manager and team for day-to-day internal problem solving and trouble shooting. * Training and onboarding for new employees within same role, as requested. This position may require overtime and/or weekend work. * Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules. * Attendance to work is an essential function of this position. * Performs other duties as assigned by Manager/Supervisor. Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Required: * Associate's Degree in a related field and/or 1-3 years related experience and/or training. * College Level Mathematical Skills * Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs. * Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs. * High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms. Preferred: * Able to set and achieve challenging goals. * Ability to adapt to a changing work environment. * Ability to display excellent time management skills. * Ability to identify and resolve problems in a timely manner. For Illinois residents: The hiring rate for this position is $56,720-$64,000 plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k). #LI-JM1 Join us and be part of building the bridge between life changing therapies and patients. Let's talk future Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

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.

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 Quality Engineer (QE) is a key, customer-facing role that will be responsible for planning, developing, implementing and monitoring the equipment and process validation strategy for PCI's Advanced Drug Delivery business. The QE will partner with other internal team members to ensure a successful design/tech transfer with NPI by directly supporting or driving validation processes with appropriate risk management leadership. As the new product is fully scaled into commercial operations, the QE will be responsible or support all phases process qualification, ensuring the product is produced according to the established control plan, design and product specifications, and driving continual improvement by implementing validation strategies, conducting tests, and analyzing data to confirm compliance and functionality. The QVE will interact and collaborate with internal team members, customers, suppliers, and contract service providers as needed. 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. Technical (Product and Process) * Drive and support new customer programs throughout the development lifecycle and deliver on the 'One PCI' customer experience and program management * Interact with clients on an as-needed basis to support project milestones, scope changes and business development opportunities. * Develop and implement product and process workflows to ensure best engineering practices within the quality and engineering teams. * Prepares and executes validation protocols (IOQ, OQ/PQ) and validation standards, validation statements, reports, summaries, and master validation plan for new customer/product/system project launch and maintains existing validated processes and coordinating internal and customer approvals, as needed. * Ensures validation documentation completion, accuracy, and closure, including organizing and coordinating multiple approvals as required. * Development of sampling plans for OQ/PQ activities (includes Serialization activities). * Trend manufacturing data and contract service providers results for ongoing process verification. * Reviews and interprets standards, procedures, and specifications for dissemination relative to validation protocols. * Review and/or approve User Requirement Specifications, Functional Specifications, and Engineering Study Protocols Review and possibly assist in Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT) to qualify equipment. * Harmonization/streamlining of validation activities * Assistance with development of Master Batch Records, work instructions and associated manufacturing and packaging documentation. * Drive root cause analysis of deviations. * Support project teams through the selection of correct design / manufacturing concepts and fundamental technology to ensure successful project outcomes. * Develop validation work standards and packages as part of project acquisition process and following subsequent project delivery stages, to successfully deliver projects within scope, with quality, and within allocated timeframes and budget. * Interpret product requirements and design and develop concepts, components, assemblies, and products in compliance with applicable quality system procedures, industry, and business standards. * Effectively communicates project goals and progress to Supervisor / Manager. Investigates validation deviations, documenting in formal reports, and assuring resolution of corrective action to complete the project. * Coordinate validation efforts with mechanics, operators, and engineering * Attends conference calls and meetings Leadership * Collaborate with the engineering, commercial operations, procurement and ancillary groups and wider development, manufacturing, and procurement teams for high priority product-program initiatives. * Attention to detail and self-motivation to deliver work to the highest standards. * Multi-tasking, planning work, scheduling tasks, coordinating activities, and managing time efficiently. * Timely problem-solving using data driven tools and methods. * Presentation of quality standards, process flows, inspection plans, and/or issues both internally to stakeholders and externally to clients with confidence and accuracy. Other - General * Attendance to work is an essential function of this position. * Performs other duties as assigned by Manager/Supervisor within device assembly and packaging operations. May assist in the areas of NPI as needed. * Support the recruitment, management, coaching, and development of quality engineers to achieve excellence and efficiency when programs are scaled. * Knowledge of and adherence to all PCI, cGMP, GCP, GAMP, 21CFR, 21CFR Part 11 and Annex 11 policies, procedures, rules, and requirements. 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: * College or Trade Degree required (engineering degree or related scientific degree preferred). Must have a minimum of at least three years of experience in an FDA regulated industry with strong preference to medical device or combination products. * Demonstrated proficiency with personal computers, business software (e.g., MS Office) and technical software (ERP and eQMS systems). Ability to create, use and interpret scientific tables, charts, and graphs. * 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. * Analytical ability to drive effective Root Cause Analysis (RCA) and critical thinking for complex problem solving. Preferred: * Lean Six Sigma Certification, ASQ Certified Quality Engineer (CQE), or similar certifications are highly desirable. * Possesses excellent organizational, time management and multi-tasking skills to meet commitments and deadlines. * Prior experience in technical writing and utilizing root cause analysis tools is required. * Critical thinking skills along with a strong collaborative approach is required. * Technical knowledge and experience around Test Method validation, Medical Devices, and Sterilization processes is preferred. * The hiring rate for this position is $97.280.00-$115,520 plus eligibility for an 5% MBP. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), a flexible spending account, and a 401(k) plan. #LI-SW1 Join us and be part of building the bridge between life changing therapies and patients. Let's talk future Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

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: Summary Overall responsibility of the Complaints and Investigations Engineer is to compile information pertaining to consumer complaints and deviations and analyze the systems, processes and procedures to properly respond to the reported and identified defects or issues. This position helps drive project success and identify improvements 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. * Primary customer contact responsible for receipt and logging of consumer complaints and product related investigations in EQMS. * Responsible for maintaining complaint and investigation tracking systems. * Verify validity of complaint information provided by customers. * Communicate status of complaints and investigations at performance meetings. * Compile information necessary to log for trending only complaints as well as complaints which require a formal response into the complaints system. * Employ data driven tools and methodologies to perform root cause analysis when investigating complaint responses and deviations. * Interpret technical specifications, product requirements and design concepts for components, assemblies, and products to identify opportunities and develop recommendations to improve product and process design. * Write Deviation Notifications for complaints not caused by PCI. * Enter, monitor, track, extend, and close complaint and investigation actions in EQMS. * Populate, maintain and update priority lists utilized by organization and publish as needed. * Populate, maintain and update various spreadsheets utilized for trending of products, defects, lines, etc. * Compile data and generate complaint and investigation related metrics (prepare graphs and charts from various data sources). * Coordinate and maintain documents associated with complaints and investigations. * Coordinate retain sample request, retrieval, inspection, and return. * Filing and maintaining archived documents and returned complaint samples. * Address and resolve quality events to solve problems and improve systems * Develop and implement corrective and preventative action plans. * Document quality event resolution in a formal report. * Function as a resource for statistical analysis. * Support Quality Control in maintaining GMP compliance and system improvement. * Support Customer audit activities. * Evaluate statistical data as it pertains to investigation and complaint reports. * Monitor and respond to customer questions/concerns. * Complete Retain Only Review form as requested by the customer. * This position may require overtime and/or weekend work. * Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules. * Attendance to work is an essential function of this position * Performs other duties as assigned by Manager/Supervisor Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Required: * Bachelor's Degree in a related field and/or 1-3 years related experience and/or training. * College Level Mathematical Skills * Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs. * Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs. * Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables. * Preferred * Ability to adapt to changing work environments. * High Standard of Report Writing The hiring rate for this position is $62,960-$70,830 plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), a flexible spending account, and a 401(k) plan. #LI-SW1 Join us and be part of building the bridge between life changing therapies and patients. Let's talk future Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

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. Working with Business Development Executives, providing high quality clinical packaging and distribution proposals within expected timeframe. Based on quote requirements, works with various internal departments to calculate complex costing in order to deliver Proposals and Change Orders to customer's right first time. Prepares and presents proposals to Business Development Executives and customers during customer facing meetings when applicable. ESSENTIAL DUTIES AND RESPONSIBILITIES: * Collaborates with Subject Matter Experts (SME) to gather supporting information to be captured within Proposals. * Reviews clinical trial strategies presented within Request-for-Quote (RFQ) and calculates quantities of materials needed for production. * Assigns costs within Proposals based on services quoted. * Works with Sales, Project Management and external customers to resolve issues associated with Proposals or Change Orders. * Leads meetings with internal departments and externally with clients to discuss expectations associated with Proposals, revisions to proposals and Change Orders. * Act as a liaison between Project Management and Business Development Executives to support the transition of awarded Proposals into Project Management teams. * Develops and writes project timelines to be utilized within Proposals. * Proactive in asking questions to obtain answers, collecting business process information, and working with others in a positive and collaborative manner. * Manages and prioritizes competing requests for multiple parties to ensure all tasks are completed. * Actively participates in drafting Change Orders, Proposals & Revisions to Proposals. * Demonstrates moderate to advanced abilities in MS Office (Excel, Word) * Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules. * Attendance to work is an essential function of this position * Performs other duties as assigned by Manager/Supervisor. QUALIFICATIONS: Required: * Associate's Degree in a related field and/or 1-3 years related experience and/or training. * 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. * Intermediate Reasoning: Ability to apply common sense understanding to carry out instructions that may be furnished in written, oral, or diagram form. Ability to deal with problems that involve several concrete variables in standardized situations. Preferred: * Ability to demonstrate attention to detail. * Ability to exhibit sound and accurate judgment * Ability to hold oneself in a professional manner. * Ability to adapt to changing work environments. * Excellent Time management skills. * Ability to perform high quality work in fast paced environment. #LI-RS1 The base salary hiring range for this position is ($51,120 to $57,510) 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.