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Manufacturing Compliance Specialist

vor 1 Monat


Lengnau BE, Bern, Schweiz Thermo Fisher Scientific Vollzeit
Job Title: Manufacturing Compliance Engineer

Thermo Fisher Scientific is seeking a highly skilled Manufacturing Compliance Engineer to join our team. As a key member of our operations team, you will be responsible for ensuring the quality, safety, and compliance of our manufacturing processes.

Key Responsibilities:
  • Provide support and solutions in Drug Substance Manufacturing areas, including USP, DSP, and Solution Preparation.
  • Supervise 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.
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.
What We Offer:

You can expect a multifaceted job in a dynamic and international environment, competitive remuneration and comprehensive benefits package, and outstanding career and development prospects.

A culture in which you live integrity, intensity, involvement, and innovation. A well-founded induction and task-specific training are a matter of course for us.

You yourself resolve your future in our company – make your contribution to joint success.

When your part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment, or making sure our food is safe.