Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. PCI is an investment in people who make an impact, drive progress and create a better tomorrow.
Requirements
- 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 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 maintain 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; participate 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.
- Inspire and constantly strive 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
Benefits
- Opportunity to work in a dynamic and complex manufacturing environment
- Ability to adapt to a changing process daily
- Expected to be flexible with the process and adjust work hours accordingly
- Work with cross-functional support teams
- Join a company that is committed to equity and inclusion