More jobs:
Production Lead
Job in
Millburn, Essex County, New Jersey, 07041, USA
Listed on 2026-02-16
Listing for:
Harba Solutions Inc.
Full Time
position Listed on 2026-02-16
Job specializations:
-
Manufacturing / Production
Pharmaceutical Manufacturing, Operations Engineer, Manufacturing Engineer, Validation Engineer
Job Description & How to Apply Below
The Production Lead acts as the primary point of contact on the manufacturing floor during the shift. You’ll help drive execution of sterile production batches, maintain documentation accuracy, and partner cross-functionally with Quality, Maintenance, and Support teams to keep operations running smoothly.
Success in this role comes from strong attention to detail, calm decision-making under pressure, and the ability to coach people while maintaining high compliance standards.
Key Responsibilities- Coordinate and lead daily manufacturing activities within a cleanroom environment
- Provide real-time support to technicians during batch execution
- Verify line clearance, material readiness, and equipment status prior to production
- Ensure adherence to GMP documentation practices (batch records, logbooks, checklists)
- Review production paperwork for completeness and accuracy
- Escalate and help investigate deviations, nonconformances, and process issues
- Partner with Quality to support investigations and corrective actions
- Maintain an inspection-ready area through proper housekeeping and organization
- Train and mentor operators on aseptic behaviors and procedural compliance
- Support shift handoffs and communicate production status across teams
- Identify opportunities to improve efficiency, workflow, and compliance practices
- Experience working in regulated manufacturing (pharma, biotech, biologics, sterile, or medical device)
- Hands‑on work inside a cleanroom or controlled environment
- Experience guiding, training, or leading operators/technicians
- Familiarity with batch documentation and quality systems
- Ability to follow and enforce procedures with a strong quality mindset
- Strong communication and organizational skills
- Aseptic processing or sterile manufacturing
- Fill‑finish, injectable, biologics, or advanced therapies manufacturing
- Deviation investigations / CAPA support
- Audit or inspection readiness activities
- SOP authorship or revisions
- Cleanroom gowning and PPE required
- Fast‑paced, team‑oriented production setting
- Standing and moving within manufacturing areas for extended periods
- Occasional extended hours or schedule flexibility based on production needs
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