Production Specialist IV

At PCI, we believe our employees are our greatest asset. Therefore, we offer a benefits package designed to support their well-being and contribute to a good quality of life.

• Competitive salary

• Medical insurance and medication reimbursement

• English classes

• Discounts on various activities and services

• Agreements and advantages with gyms

• Referral program

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 Production Specialist IV provides specialized technical support to the manufacturing team in complex activities, ensuring compliance with GMP, FDA, and other applicable regulations, as well as safety and quality standards.

Acts as an SME (Subject Matter Expert) for Production processes, especially in aseptic manufacturing and filling operations with isolator technology, and actively participates in continuous improvement, qualification, and validation of equipment and processes. Likewise, they may coordinate and supervise the work of other specialists and collaborate with Quality, Development, and other Operations departments.

• Act as a technical reference (SME) in aseptic manufacturing and isolator filling processes.

• Provide technical support in equipment qualification, process validation, Media Fill, contamination control, sterility assurance, and troubleshooting.

• Prepare, define, and review high-complexity GMP documentation and procedures.

• Lead and participate in deviations, change controls, CAPAs, and other quality investigations.

• Review batch records and guarantee compliance with GMP and regulatory standards.

• Lead continuous improvement initiatives, optimizing processes, times, and costs without compromising quality.

• Participate in new production projects, identifying needs, adapting procedures to EU GMP Annex 1, and collaborating with cross-functional teams and suppliers.

• Coordinate and follow up on the work of other specialists when necessary.

• Deliver training and provide technical guidance to Production personnel.

• Collaborate with Quality, Development, and other departments in resolving technical and operational needs.

• Contribute to the maintenance of safe, orderly working conditions in compliance with Health, Safety, and Environment standards.