Manufacturing Lead (3rd Shift)
About the job
Lead and coordinate daily manufacturing operations, including aseptic processing, batch compounding, filling, and equipment setup.
Ensure compliance with 21 CFR Parts 210/211, FDA 503B guidance, USP, and internal SOPs.
Provide on-the-floor supervision, coaching, and training for manufacturing technicians.
Review batch records, logs, and production documentation for completeness and accuracy.
Partner with Quality and Engineering to resolve deviations, support investigations, and implement CAPAs.
Maintain readiness for regulatory inspections and internal audits.
Monitor equipment performance, material usage, and workflow to optimize efficiency and reduce downtime.
Support implementation of process improvements, validation activities, and new product introductions.
Qualifications
- Experience in sterile manufacturing, aseptic technique, or pharmaceutical production (503B or GMP environment preferred).
- Strong understanding of cGMP, cleanroom behavior, and environmental monitoring expectations.
- Demonstrated leadership or lead-operator experience.
- Ability to interpret batch records, SOPs, and regulatory requirements.
What's on Offer
We offer a dynamic environment where talent and ambition can develop to its fullest.
We have an open and informal organization culture, where individuals need to have strong motivation and ability to work independently.
Fagron is a widely expanding, international, professional, and ambitious pharmaceutical company with multiple growth opportunities.
Job opportunity includes competitive salary, comprehensive benefits, performance package, and ability to be part of an international leader in an expanding industry.