Manufacturing Technician II, M-F

The Manufacturing Technician II proficiently performs a variety of complex tasks under general guidance and in accordance with the manufacturing instruction set inclusive of current GMP/ISO requirements and standards and following all safety guidelines of PCI.

This role involves routine and critical manufacturing operations, including but not limited to equipment preparation, formulation, aseptic compounding, and filling activities for biopharma and medical device products. The technician works with Master Production Records and standard operating procedures.

• Maintain and adhere to safe work habits and all applicable PCI safety procedures and guidelines.
• Execute and possess knowledge of aseptic techniques.
• Prepare solutions, aseptic filling, and labeling of vials under sterile and non-sterile conditions, routine solution and filtration, vial and component preparation, and sterilization.
• Assemble, disassemble, and operate aseptic filling equipment and lyophilizer equipment in classified cleanroom and controlled non-classified environments.
• Operate vial capper and unload product from lyophilizers and liquid fill lines.
• Prepare equipment and components for sterilization and lyophilization.
• Operate processing equipment including autoclaves, ovens, vial washers, depyrogenation, centrifuges, and mills.
• Assist in the formulation and dispensing of product in a clean room environment per SOPs and MBRs.
• Sanitize production areas and prepare equipment for production.
• Complete and maintain documentation related to assigned work, including logbooks and batch records.
• Adhere to verbal instructions and written procedures in operating production equipment and performing processing steps; accurately complete appropriate production documentation.
• Identify, document and, if necessary, participate in investigations of events that deviate from normal operation.
• Maintain compliance, cleanliness, and orderliness of operational areas per appropriate SOPs.
• Perform COP, CIP, and SIP operations to prepare equipment for manufacturing operations.
• Review and revise pertinent SOPs and production batch records as required.
• Participate in media fill/aseptic proficiency tests.
• Inspire and constantly strive to make PCI a great place to work, respected for the quality of its people and products and clients.

• 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.

Interacts with cross‑functional support teams such as Operations, QA, QC, Engineering, R&D, Validation, etc. This is an individual‑contributor role.

• 2‑4 years of working experience, preferably in a manufacturing environment ideally in the pharmaceutical or medical device industry.
• Fill‑finish experience preferred.
• Requires associate degree with 0‑2 years’ experience or high school diploma with 1‑3 years related manufacturing experience or associate degree in Life Sciences/Engineering field with 1 year of cGMP Manufacturing experience or Biotech Certificate and 1 year of experience.
• Attention to detail with good mechanical aptitude.
• Good attitude and good interpersonal skills.
• Honesty, integrity, respect, and courtesy with leadership and peers.
• Demonstrates a commitment to conducting PCI business according to the highest legal and ethical standards, and to continually pursue excellence in the manufacturing and delivery of PCI products and services.
• Resiliency, the ability to move forward despite mistakes, with a sincere desire to improve.
• Ability to work as a self‑starter and handle multiple priorities in a dynamic cross‑functional team‑based environment.

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.