2nd shift (2:00pm–10:00pm); available to work weekends and holidays as needed.
Main Responsibilities:
- Manage people/process within a process/product team to meet goals and priorities.
- Ensure packaging operations for syringes and vials vaccines meet established requirements.
- Assure compliance with regulatory authorities and cGMPs/CBER/WHO/EP and other regulatory bodies.
- Plan/initiate overall production schedules; coordinate personnel with Manufacturing staff.
- Review batch records for correctness and completeness.
- Lead employee selection, training, development, counseling recommendations, cost control, quality, incident investigations, and departmental capital/operating budgets.
- Provide managerial coverage for employees during third shift as required.
- Identify/present technical process improvements and communicate issues to relevant groups; support unit teams.
- Coordinate Maintenance, Metrology, and Validation activities when necessary.
- Implement new equipment and procedures.
Required/Preferred Qualifications:
- Min: High School Diploma/GED + 5+ years’ experience in a cGMP or similar regulated environment.
- Preferred: Bachelor’s degree + 3+ years’ experience in a cGMP or similar regulated environment.
- Prior experience working in a pharmaceutical company production department.
- Ability to work overtime and flexible hours, including weekends.
Benefits (as stated): health and wellbeing benefits (including healthcare, prevention/wellness programs) and at least 14 weeks’ gender-neutral parental leave.