Drug Product Manufacturing Technician

The Drug Product Manufacturing Technician learns and performs a variety of tasks with supervision and in accordance with the manufacturing instruction set inclusive of current GMP/ISO requirements and standards, following all safety guidelines of PCI.

• Maintains and adheres to safe work habits and all applicable PCI safety procedures and guidelines.
• Demonstrates general knowledge of aseptic techniques.
• Prepares solutions, aseptic filling, and labeling of vials under sterile and non-sterile conditions, routine solution and filtration, vial and component preparation and sterilization.
• Assembles, disassembles, and operates aseptic filling equipment and lyophilizer equipment in classified cleanroom and controlled non classified environments.
• Operates vial capper, unloads product from lyophilizers and liquid fill line.
• Prepares equipment and components for sterilization and lyophilization.
• Operates processing equipment including autoclaves, ovens, vial washers, depyrogenation, centrifuges, mills equipment.
• Assists in the formulation and dispensing of product in a clean room environment per SOPs and MBRs.
• Sanitizes production areas and prepares equipment for production.
• Completes and maintains documentation related to assigned work, including logbooks, batch records, etc.
• Adheres to verbal instructions and written procedures in operating production equipment and performing processing steps; accurately completes appropriate production documentation.
• Identifies, escalates and documents events that deviate from normal operation; participates as needed in investigations.
• Maintains compliance, cleanliness and orderliness of operational areas per appropriate SOPs.
• Performs COP, CIP, and SIP operations to prepare equipment for manufacturing operations.
• Reviews and revises pertinent SOPs and production batch records as required.
• Participates successfully in media fill/aseptic proficiency tests.

• Ability to wear personal protective equipment such as safety glasses/goggles, gloves, and safety shoes.
• Ability to gown and gain entry to controlled manufacturing areas.
• Ability to lift, pull or push equipment requiring up to 25-50 lbs of force.
• Ability to stand for 6 hours in a production suite.
• Ability to work any shift (up to 10 hours) as required dependent on business needs.
• Ability to adapt to a changing process daily.
• Ability to work under the scrutiny of clients daily.
• Expected to be flexible with the process and adjust work hours accordingly.

Travel: less than 10% of time.

• 0–2+ years of working experience, preferably in a manufacturing environment ideally in the pharmaceutical or medical device industry.
• Minimum of a high school diploma/equivalency.
• Ability to weigh and measure raw materials and operate basic benchtop instruments.
• Ability to follow written instructions.
• Seeks help with more complex and non-routine tasks.
• Good verbal and written communication skills.
• Pay attention to detail.
• Demonstrates a good mechanical aptitude.
• Commits to conducting PCI business according to the highest legal and ethical standards.
• Openly receives and implements feedback, resilient, able to move past mistakes; applies learning.
• Self-starter, able to work in a fast dynamic work setting.

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 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.