About the role:
As the Lead Manufacturing Technician, execute production processes while strictly adhering to cGMP and environmental health and safety guidelines and applicable regulations. Hands-on execution of production activities under general direction; participate in departmental projects and quality working teams. Revise and write complex procedures or initiate new procedures. Perform complex troubleshooting and may assist with technology transfer into manufacturing. Requires technical and administrative competence to organize and lead production activities and demonstrate leadership in cGMP compliance and EHS.
Shift:
Day shift, 5:00am β 5:30pm, 2-2-3 schedule.
How you will contribute:
- Lead training/mentoring for manufacturing tech progression (Level 1β3)
- Conduct safety Gembaβs and coach daily on proper ergonomic techniques
- Support local manufacturing operations
- Use electronic systems (e.g., EBM, JDE)
- Operate filling, inspection & packaging equipment
- Ensure GDP/GMP paperwork; monitor production cleaning
- Clean portable equipment and small parts; assemble/operate filtration systems
- Prep components for manufacturing schedule adherence; set up incoming shift
- Troubleshoot process/equipment issues to minimize downtime
- Coordinate with maintenance/metrology for preventative maintenance
- Participate in Continuous Improvement Teams; receive/distribute supplies
- Additional duties as assigned
Must/Required skills & qualifications:
- Speak/read/write/follow detailed instructions in English; excellent written/verbal communication
- Exceptional procedural writing skills
- High school diploma or GED required; Associate degree+ preferred
- 6+ years manufacturing experience in regulated environment (or 4+ years with Associate degree+)
- Strong understanding of cGMP/GDP and manufacturing documentation
- Hands-on troubleshooting of pharmaceutical manufacturing equipment (filling, inspection, packaging, filtration, autoclave preferred)
- Quantitative analysis ability; work with metric and USA measurements
- Leadership/mentoring/coaching experience
- Interpersonal skills; work effectively in a team environment
- Knowledge of chemical/biological safety procedures; good computer skills
Preferred:
- Prior pharmaceutical/biotech/medical device regulated manufacturing experience
- Experience with EBM/JDE and Microsoft Office
Benefits/Compensation:
Not included (pay/benefits summary removed).
Application instructions:
None provided in job-description body.