Drug Product Manufacturing Technician

Drug Product Manufacturing Technician

Learn and perform a variety of tasks with supervision, in accordance with manufacturing instruction set inclusive of current GMP/ISO requirements and standards, and following all safety guidelines.

With supervision, the technician performs routine and critical manufacturing operations, including but not limited to equipment prep, formulation, aseptic compounding, and filling activities for biopharma and medical device products.

• 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, and 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.
• Inspires and constantly strives to make PCI a great place to work and respected for the quality of its people and products and clients.
• Successfully participates in media fill/aseptic proficiency test.

• 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.