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 tooptimizeefficiency and reduce downtime.
• Support implementation of process improvements, validation activities, and new product introductions.

• 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.

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.

Fagron US is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law.

Fagron US is proud to be an affirmative action and equal opportunity employer.