Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
Job 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.