Role Summary
RMF Production Technician - Vaccines is a cGMP manufacturing role within the Biologics team, supporting the startup and ongoing operations of the B55 Recombinant Manufacturing Facility and eventual cGMP commercial manufacturing of vaccine substances. The position requires collaboration across cross-functional teams, strong technical knowledge, and leadership to ensure safe, compliant, and efficient production processes. This is a 3rd shift role with potential weekend and holiday requirements.
Responsibilities
- Ensuring that processes are always compliant with FDA regulations.
- Trainability in all assigned training modules.
- Identify and prevent deviations; assist in investigation and root cause analysis.
- Assist with deviation investigations, CAPA, CCR, and other projects.
- Ensure quality documents (eBRs, electronic logbooks) are completed accurately and on time.
- Maintain real-time documentation for compliance and quality control.
- Prepare areas for the next shift to maintain smooth operations.
- Use materials efficiently to reduce waste.
- Share improvement ideas and provide solutions to team members.
- Proactively identify and resolve production issues to ensure smooth operations.
- Follow procedures to ensure safety; participate in monthly safety meetings.
- Report safety issues, incidents, and near misses promptly.
- Participate in safety walkthroughs and contribute ideas for corrective actions.
Qualifications
- Required: High School Diploma plus one year of experience in a cGMP environment or pharmaceutical experience.
- Required: Associate Degree or Bachelorโs degree with 0 years of experience.
- Required: Good mechanical skills, computer skills, and detail orientation.
- Required: Basic mechanical aptitude, computer skills, good comprehension and retention, troubleshooting, and manual dexterity.
- Required: Proficiency in at least one area of operation or product line.
Education
- High School Diploma;/or Associate/Bachelorโs degree as listed above.
Skills
- Strong mechanical aptitude and problem-solving abilities.
- Attention to detail and accurate documentation skills.
- Proficiency with basic computer tools and electronic documentation.
Additional Requirements
- Ability to lift up to 50 lbs.
- Ability to stand for ~8 hours per shift.
- Ability to gown and gain entry to manufacturing areas.
- Flexible with work schedule; may include modified shifts, weekends, or holidays.
- Potential to flex to another platform or building within Biologics/Manufacturing & Supply; possible aseptic processing area work.
- Fit testing for N95 may be required depending on area.