Overview
Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc. allowed, Loud Noises (Equipment/Machinery), Office, Some degree of PPE required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Direct Report To: Manufacturing Engineering Manager, Number of Direct Reports: 0
Job Summary
Join the Manufacturing Engineering team, focusing on improving BPC / Chambers manufacturing equipment and processes. Support the creation and execution of procedures to cGMP Standards, lead engineering projects to meet performance goals, budgets, and timelines. Conduct investigations into validation failures, implement corrective actions, and address technical issues.
Experience
* Mechanical/Process/Manufacturing Engineering/Science Degree or equivalent experience in engineering or another scientific field.
* Experience:
* Prior practical validation experience involving Factory Acceptance Testing, Site Acceptance Testing, and IQ/OQ protocols.
* Having previous experience in the pharmaceutical sector provides a benefit.
* Experience working within a regulated industry/environment is essential.
* Leading/assisting qualification project executions and close out.
* Self-motivated, proactive, and capable of adhering to project timelines
* Writing, reviewing, and implementing of project URS, FAT, IQ/OQ, DoE & PV protocols.
Knowledge, Skills, Abilities
* Proficient understanding of Quality systems in the Pharmaceutical Sector
* Proficient in Solidworks or AutoCAD is important.
* Attention to detail and ability to identify and remediate issues found during testing.
* Highly effective verbal and written skills, including technical authorship.
* Proficient in Microsoft Office, particularly Microsoft Word and Excel
* Understanding of cGMP for all paperwork required.
Company
Thermo Fisher Scientific values the individual narratives of each of our 130,000 brilliant employees. Join our team and support our goal of helping customers improve the health, cleanliness, and safety of the world.
Benefits
Joining Thermo Fisher offers a competitive salary, holidays, annual bonuses, Private Health Insurance, Life Insurance, and a Pension Plan. Customize your benefits with our Flexible Benefits Package.
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