Manufacturing Compliance Specialist
vor 4 Wochen
As a Manufacturing Compliance Engineer at Thermo Fisher Scientific, you will play a key role in ensuring the quality, safety, and compliance of our drug substance manufacturing processes. This includes providing support and solutions in areas like USP, DSP, and Solution Preparation, as well as supervising equipment installation, maintenance, and calibration. You will also be responsible for reviewing exceptions, supporting batch record reviews, and leading deviation investigations and CAPAs. Additionally, you will drive continuous quality and process improvements using Practical Process Improvement methodologies and collaborate with various departments to represent DS Manufacturing in external interactions.
Responsibilities
- Provide support and solutions in Drug Substance Manufacturing areas like USP, DSP, and Solution Preparation.
- Supervise as process owner equipment installation, maintenance, and calibration, ensuring top performance and alignment to industry standards.
- Ensure quality, safety, and compliance by reviewing exceptions, supporting batch record reviews, and leading deviation investigations & CAPAs.
- Drive continuous quality and process improvements using Practical Process Improvement (PPI) methodologies.
- Collaborate with various departments and represent DS Manufacturing in external interactions.
Requirements
- Bachelor/Master/PhD in Chemistry, Biochemistry, Biotechnology, Biology, or Food Science.
- Proficiency in English; German is a plus.
- Minimum of 5 years in pharmaceutical operations within a GMP environment.
- Strong experience in biotech processes, sterile processes, and production equipment handling.
- Willingness to travel occasionally and availability for remote on-call duties.
About Us
At Thermo Fisher Scientific, we are committed to equal opportunity and cultural minority support and do not discriminate based on ethnic origin, color, religion, gender, sexual orientation, gender identity, national origin, disability, or legally protected status. We offer a multifaceted job in a dynamic and international environment, competitive remuneration, and comprehensive benefits package, as well as outstanding career and development prospects.
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