The Production Technician - Sterile Fill Finish position is responsible for clean prep, weighing/formulation, mixing and/or sterile filtration of non-sterile ingredients for sterile finished injectable drug products. This employee should be familiar with quality-regulated manufacturing environments and current Good Manufacturing Practice. In addition, the Sterile Fill Finish technician will be responsible for performing aseptic technique to fill sterile injectable products and preparations. This employee should be focused on the sterility assurance of both manufactured and compounded drugs made by the Company.
DUTIES, RESPONSIBILITIES AND FUNCTIONS:
- Works as a Production Technician in Sterile Fill Finish to perform aseptic technique in a clean room environment.
- Assist with the qualification of manufacturing equipment in support of facility start up.
- Participate in the execution of all phases and facets of drug product clean prep, formulation, and sterile fill as applicable.
- Performs manufacturing fill finish activities in accordance with current Good Manufacturing Practices.
- Performs formulation calculations and completes appropriate documentation.
- Performs cleaning and sanitization of aseptic manufacturing areas.
- Demonstrates appropriate use of garbing and compliance with 21 CFR 211, 503B guidelines, as well as other sterile fill finish regulations.
- Performs operations related to aseptic filling including but not limited to part washing, formulation, weighing, filter integrity testing, inventory accountability, autoclaving, and working with an automatic filling isolator.
- Execute production recipes, check-in equipment, and perform material movements using automated computer software applications.
- Completes and reviews batch records and logbooks in accordance with cGMP standards and follows written procedure.
- Ability to work and coordinate with other production teams to ensure timely production of scheduled lots.
- Work effectively and efficiently in a team-oriented environment to ensure maximum and high-quality output.
- Read and understand all company policies, guidelines, and procedures.
- Accountable/Responsible for completing all required cGMP & safety training on time.
- Ensure all equipment and facilities are maintained in accordance with SOPs.
- Utilizes proper judgement to perform other duties.
- Complies with applicable local, state, and federal laws, rules, and regulations.
EDUCATION & REQUIREMENTS:
- High School diploma or general education degree (GED) required.
- Knowledge of aseptic techniques (IV Certified, preferred).
- Knowledge and demonstrated understanding of Good Manufacturing Practices (GMPs) and how it applies to specific responsibilities and manufacturing operations.
- Ability to read and understand production and technical documents as well as perform calculations.
- Licensed and registered as a Pharmacy Technician (CPhT) preferred.
- Demonstrate Good Documentation Practices (GDP).
- Demonstrate Clean Room Gowning (ISO7) or Aseptic Gowning Techniques.
- A minimum of 5 years’ experience working in a quality regulated, pharmaceutical environment or facility.
- Component Prep, Weighing/Formulation, Aseptic Filling experience preferred.
- Familiarity with pharmaceutical drug products, sterile compounded products, and/or biologic drug products.
- Experience / participated in FDA or similar regulatory inspections.
- Maintain current knowledge in up-to-date regulatory/industry standards related to Environmental Monitoring and Microbiology, as well as facilitate proper dissemination of information.
- Familiar with online training applications.
- Proficient with MS Office application skills.
- Self-motivated and detail oriented.
- Ability to carry out detailed written and verbal work instructions.
- Capable of lifting up to 50 lbs and stand for extended periods of time for consecutive days.
- Able to work safely around hazardous substances (drugs).