Manufacturing Technician IV

Description

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 Level IV Production Operator independently executes and leads complex aseptic manufacturing activities, including preparation, formulation, filtration, filling, equipment sterilization, and continuous improvement activities within the Production area. Works in accordance with established procedures and complies with cGMP, AEMPS, FDA, and other regulatory authority requirements, ensuring quality, safety, and adherence to production plans. This position requires a high level of technical knowledge, autonomy, attention to detail, and leadership capability, typically acquired after a minimum training period of approximately five years. **Key Responsibilities** * Execute and lead aseptic manufacturing activities in Grade A/B, C, and D environments, including preparation and setup, formulation, filtration, filling, sanitization, and disinfection. * Lead SIP activities, including complex sterilizable equipment and systems, and support equipment and process qualification. * Operate and ensure proper functioning of production equipment, following SOPs, manufacturing guidelines, and GMP requirements. * Ensure compliance with safety, quality, GMP, and applicable regulatory requirements. * Manage and maintain GMP documentation correctly, including batch records, logbooks, and associated records. * Participate in deviation investigations, CAPAs, change controls, and other quality events, as well as regulatory and customer inspections. * Identify and promote continuous improvement opportunities and collaborate with other departments when necessary. * Manage preparation and availability of materials and consumables required for production. * Maintain cleanliness, order, and control standards in classified and non-classified production areas. * Maintain required qualifications, including gowning and Media Fill, and correctly apply aseptic techniques. * Provide technical training and support to Level III Technicians. * Serve as backup for the Shift Supervisor, assuming delegated responsibilities when required. * Work collaboratively, providing support, guidance, and technical leadership to other team members in the area. 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.*