Formulation Technician III M-F

Overview

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.

• Mentor others in a variety of complex tasks under general guidance and in accordance with the manufacturing instruction set, current GMP/ISO requirements, and PCI safety guidelines.
• Perform manufacturing operations under general supervision, including equipment prep, dispensing, dissolution, formulation, purification, and aseptic compounding for biopharma and medical device products.
• Address non-routine matters using technical knowledge and experience to resolve complex manufacturing problems; monitor personnel interactions and escalate issues to management when needed.
• Work with Master Production Records and standard operating procedures; train and guide less experienced personnel.
• Model PCI Guardian values and behaviors.
• Maintain safe work habits and comply with PCI safety procedures; proactively identify safety risks and alert management for corrective action.
• Train and mentor peers and less experienced staff in proper formulation techniques; own daily formulation activities to ensure scheduled tasks are completed.
• Manage critical steps in the formulation process, including lab setup and process flows, in-process testing, API dissolution, and final QS, while ensuring safety, batch integrity, and error prevention.
• Troubleshoot equipment or process issues; adhere to verbal instructions and written procedures for operating production equipment and processing steps; complete production documentation accurately.
• Prepare equipment and components for sterilization and lyophilization; operate processing equipment (e.g., autoclaves, depyrogenation ovens, vial washers, homogenizers) as required.
• Maintain cleanliness and orderliness of operational areas per SOPs; collaborate with Supervisor and MTS when drafting new batch records and protocols; complete batch records prior to supervision review.
• Comply with area SOPs and cGMP requirements; initiate and support revisions to SOPs and forms as needed.
• Participate in investigations and contribute to corrective and preventive actions; cross-train to increase technical skills across the department.
• Communicate issues, challenges, and opportunities for process improvements to management and clients in a timely manner.
• Perform other manufacturing tasks (e.g., filling, capping) as needed.
• Contribute to a positive work environment and support PCI’s mission to deliver quality products to clients.
• Collaborate with enabling groups to improve or implement processes.

The physical demands and work environment described here are representative of those required for this job. The employee must be physically capable to perform the duties listed with or without reasonable accommodations. Conditions may include standing for long periods, lifting up to 30 lbs repeatedly, and wearing PPE (mask, gloves, respiratory).

Work involves direct interaction with aseptic and non-aseptic personnel. Close collaboration with Quality Assurance, MTS, Validation, and related groups. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

• High school education; AS or BS degree in a related field preferred.
• Experience and knowledge of formulation/compounding tools and equipment.
• Minimum 4 years of formulation/compounding experience in a GMP environment, preferably in fill-finish pharmaceutical operations.
• Ability to prioritize multiple projects; strong interpersonal and communication skills; attention to detail; positive attitude.
• Proficiency with MS Office; ability to follow rules and regulations; resilient and flexible.

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, sexual orientation, gender identity or expression, genetics, disability, military status, or any other protected status. We are committed to equity and inclusion and strive to foster an inclusive workplace.

PCI focuses on quality and operational excellence, delivering industry-leading customer experience. We value authentic culture, purposeful work, and opportunities for growth. Our approach emphasizes learning through real-life experience and a fair, competitive rewards program.