Work Schedule
Standard (Mon-Fri)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety StandardsJob Description
Purpose of the Job
The Quality Engineer ensures that biopharmaceutical manufacturing at Thermo Fisher Scientific Groningen aligns with international quality standards (FDA, EMEA, ICH).
This involves developing, implementing, maintaining, and auditing Quality Systems across manufacturing on daily basis.
Job and Position Context
The Groningen site manufactures Bulk Drug Substances (BDS) via mammalian cell culture.
This facility follows all rules and regulations of current Good Manufacturing Practice (cGMP) set by individual jurisdiction health and welfare ministries.
Key Responsibilities
The Quality Engineer ensures cGMP manufacturing activities are completed according to requirements, adhering to SOPs and regulatory guidelines.
Responsibilities include:
- Engaging directly with manufacturing operations to ensure compliance, document review, and deviation handling.
- Supporting all phases of batch documentation, including initiation, authoring, approval, and mastering.
- Reviewing and approving cGMP documentation.
- Ensuring alignment of Standard Operating Procedures and documentation practices for efficient quality release of materials.
- Conducting incident investigations to understand root causes and prevent recurrence.
- Using electronic databases (e.g., Trackwise) to document quality-related events.
- Operating under various quality oversight models based on manufacturing modes.
- Communicating effectively in electronic, written, and verbal forms with shareholder dpeartments (QC, ENG, MSAT, OPS)
- Performing internal audits.
- Performing quality controls before line clearance controls and driving change-over activities.
Skills and Networking
- Ensure product compliance with cGMP and customer requirements.
- Continuously develop expertise in quality assurance.
- Collaborate closely with QA Officers and other departments.
- Engage with internal and external QA professionals and specialists.
Quality and SHE
Work according to Safety, Health, and Environmental (SHE) guidelines and GMP standards.
Top Skills
What We Do
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
Why Work With Us
You will join a company which every colleague has the opportunity to create possibilities, for oneself, for our customers and patients. There is no more exciting place to be than at the forefront of solving problems which help improve lives around the world. As a company, we are committed to supporting your career aspirations and your journey.
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