Ensure compliance of manufacturing processes, batch record approval, technical batch release, and support production teams while improving quality processes.
Work Schedule
Standard (Mon-Fri)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)Job Description
Join Thermo Fisher Scientific Inc. for an exceptionally rewarding career where your contributions help craft the future of science and health!Job DescriptionAs an engineer at Thermo Fisher Scientific Inc., you will be at the forefront of innovation and excellence in the pharmaceutical industry. Your work will be crucial in ensuring the flawless execution of our manufacturing processes and the successful implementation of quality and compliance measures.
Responsibilities:- Ensure compliance of the manufacturing processes, batch record, deviation, change control, and CAPA.
- Review and approve completed batch records within defined timelines.
- Responsible for technical batch release.
- Provide active on-the-floor support to the production team.
- Review and approve operational elements such as procedures and related documents, including specifications, working instructions, and impact assessments.
- Assist with continuous improvement initiatives related to quality documents and processes.
- Supervise the preparation of the Annual Product Review (APQR) and ensure its execution within the due date.
- Be present on the floor during critical manufacturing steps.
- Uphold and share data integrity rules (ALCOA+).
- Propose improvements to flows, manufacturing activities, and organizational processes.
- Seeking pharmacists or scientists with a master's degree or equivalent experience. Requires 3-5 years in pharma (biotech) and 1 year in commercial batch release.
- In-depth knowledge of pharmaceutical manufacturing processes, particularly biologic drug substances.
- Proficient in German and English, with strong oral and written communication skills.
- Experience with SAP and electronic MES (manufacturing execution system) is a plus.
- Ability to provide on-call services remotely based on departmental needs.
Top Skills
Electronic Mes
SAP
Thermo Fisher Scientific Waltham, Massachusetts, USA Office
168 Third Avenue, Waltham, MA, United States
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