Manufacturing Compliance Engineer

at  Thermo Fisher Scientific

JOB DESCRIPTION

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. Our distributed team of more than 100,000 colleagues delivers an outstanding 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.
The state-of-the-art multi-purpose manufacturing facility is crafted for large-scale production of biologics and has high expansion potential. Our site in Lengnau will offer highly flexible biomanufacturing technologies, from development to large-scale production including stainless steel equipment to meet our customer needs.
We are seeking a highly skilled Manufacturing Compliance Engineer qualification to join our Operational Support team in Lengnau. We need your expertise to maintain the highest levels of quality, safety, efficiency, and compliance in our manufacturing operations. You’ll tackle operational issues, drive process improvements, and support new production lines and processes.

YOUR QUALIFICATIONS:

• 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.

• Provide support and solving 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.
• Take personal accountability for presence, performance, and efficiency.
• Think and act with a customer-centric approach.