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: Responsible for planning, executing and leading various validation project assignments. Including execution of line trials, development of validation strategy, qualification of equipment, processes, instrumentation and systems related to the packaging operation. Works closely with Tech Services, Production and Customer Service teams to ensure customer specifications are met and that these specifications comply with internal operating 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 include the following but other duties may be assigned. 1. Generation of line trial protocols. 2. Execution of line trials with the support of Tech Services or Maintenance as required. 3. Review and approval of executed line trials. 4. Works with the Technical Writer to ensure line trial learnings are captured in master production batch records. 5. Generation of IQ/OQ documents for new equipment. 6. Execution of IQ/OQ activities with the support of Tech Services or Maintenance as required. 7. Develop and recommend validation strategies for product portfolios. 8. Generation of PQ protocols. 9. Provides training and support to production in the execution of PQ protocols. 10. Generation of PQ summary reports. 11. Provide technical assistance during investigations of process /equipment / cleaning / validation issues 12. Generate and resolve validation deviations / protocol discrepancies. 13. Support, investigate and troubleshoot problems and determine possible solutions. 14. Identify, respond and monitor potential project risk and determine possible contingency plans for risk mitigation. 15. Serve as a dependable technical liaison between Quality and Production. 16. Undertakes the calibration and validation of equipment and systems. 17. Assists the technical services department with annual equipment evaluation based on trending of data from PM etc. to proactively address potential issues with equipment. 18. Work on multiple projects and shift priorities as needed, track and update validation / client management on assigned projects. 19. Investigates, develops and documents Deviation/Incident Reports related to validation runs with the guidance from the Sr. QA Manager. 20. Execution of mapping studies for warehouse and cold rooms as required. 21. Management of site Pest Control program. 22. Administration & distribution of monthly PM (preventive maintenance) requirements to Tech Services 23. Logging of PM activities in the PM database. 24. Management of the PM Database, including assigning asset #s to new equipment and creating PM schedules for new equipment. 25. Assists with new product assessments to determine if a product can be packaged on-site and if cleaning validation is required. 26. Execution of cleaning validation studies, including protocol generation and summary. 27. Consistently applies company SOP’s relative to production, quality and pharmaceutical standards 28. Responsible for monitoring and adhering to GMP as well as Health and Safety Policies and Procedures; raises concerns or issues to the Sr. QA Manager . 29. Ability to interact with clients, vendors, and basic leadership skills with other consultants and contractors in a professional setting, while applying sound analytical thinking and judgment to resolve complex technical problems in a timely manner. 30. This position may require overtime and/or weekend work. 31. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules. 32. Attendance to work is an essential function of this position. 33. Performs other duties as assigned by Manager/Supervisor. 34. Other duties as required. Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions - Stationary Position: From 1/2 to 3/4 of the day. - Move, Traverse: From 1/4 to 1/2 of the day. - Operate, activate, use, prepare, inspect, or place: From 1/4 to 1/2 of the day. - Install, place, adjust, apply, measure, use, or signal: None. - Ascend/Descend or Work Atop: From 1/4 to 1/2 of the day. - Position self (to) or Move (about or to): From 1/4 to 1/2 of the day. - Communicate or exchange information: From 1/2 to 3/4 of the day. - Detect, distinguish, or determine: From 1/2 to 3/4 of the day. On an average day, the individual can expect to move and/or transport up to 50 pounds less than 1/4 of the day. This position may have the following special vision requirements. ☒ Close Vision ☒ Distance Vision ☒ Color Vision ☒ Peripheral Vision ☒ Depth Perception ☒ Ability to focus ☐ No Special Vision Requirements Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The following are some environmental conditions that one may be exposed to on a daily basis and for various lengths of time. ➢ Work is primarily performed at a desk and/or in an office environment. for 1/2 to 3/4 of the day. ➢ Work is performed in areas with moderate risk or discomfort that may require special safety precautions, such as wearing protective clothing or gear for up to 1/4 of the day. ➢ Extreme cold (non-weather) for 1/4 to 1/2 of the day. ➢ Work near moving mechanical parts for 1/4 to 1/2 of the day. The noise level in the work environment is typically, choose an item. 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: - BSc in engineering or related scientific field, Mechanical engineering preferred. - Minimum 5 years’ experience with pharmaceutical manufacturing and/or packaging. - In-depth knowledge of GMP’s, with 3 years’ experience in a Validation / Engineering role. - Exceptional attention to detail and accuracy in the maintenance of records and data. - Exceptional attention to detail and accuracy in the maintenance of records and data. - Effective interpersonal and teamwork skills. - Able to problem solve, coach as well as influence and negotiate at all levels within the organization. - Extensive computer knowledge and adeptness with various software programs including Microsoft Office and database management. - Excellent English language written and oral communication skills. - Able to oversee multiple project assignments, direct daily activities and provide on the job training to employees. 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. #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, Diversity, Equity, and Inclusion (DEI) are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture. Why work for PCI Pharma Services? At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.