Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. PCI is looking for a Manufacturing Technician IV to lead complex manufacturing tasks in a controlled environment, adhering to GMP/ISO requirements and safety guidelines. Responsibilities include preparing equipment and components for sterilization, operating aseptic filling equipment, and training and guiding less experienced personnel. Requires 4+ years of cGMP Pharmaceutical experience, strong knowledge of aseptic techniques, and proficiency in MS Office.
Requirements
- Maintains and adheres to safe work habits and all applicable PCI safety procedures and guidelines.
- Leads team to accomplish daily tasks
- Maintains weekly/daily schedule up to date and provides direction to team
- Accountable for completing daily tasks and reporting issues to management
- Works with management to provide a positive culture within operations
- Mentors less experienced staff in the performance 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
- 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 prepare equipment for production
- Completes, maintains and reviews documentation related to assigned work, including logbooks, batch records, etc.
- Trains and ensures proper training within the team prior to assigning tasks
- Troubleshoot and resolve problems with equipment or processes in the course of performing job duties
- 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; perform investigations as needed
- Maintains compliance, cleanliness and orderliness of operational areas per appropriate SOPs
- Performs COP, CIP, and SIP operations to prepare equipment for manufacturing operations
- Demonstrated understanding of sanitization and sterilization practices (build, clean and sterilize equipment to support production operations
- 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
- Health insurance
- Dental insurance
- Vision insurance
- 401k matching
- Paid time off
- Life insurance
- Disability insurance
