Merck
Director, Global Contamination Control Strategy (all genders)
Darmstadt, DEPosted 7 days ago
Full TimeSeniorDE
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Job Description
Director, Global Contamination Control Strategy (all genders) Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues acro
Key Highlights
- Develop and execute a multi-year global roadmap for contamination control and sterility assurance across biologics, small molecules, sterile fill-finish, ADCs, and new modalities.
- Author and maintain global contamination control standards, CCS, EM/CPQ methodology, and contamination FMEA, ensuring harmonized practices reflecting applicable guidance.
- Act as the leading global SME for contamination control and sterility assurance across the network and third-party manufacturers (TPMs)/CDMOs, including during health authority inspections.
- Establish and own the global Environmental Monitoring and CPQ framework, contamination FMEA methodology, and contamination response playbooks; oversee local implementations.
- Provide technical and regulatory guidance on facility design, cleanroom engineering, and microbial/particle control for aseptic and low-bioburden areas.
Qualifications
Required Qualifications
- 10+ years in sterility assurance, industrial microbiology, or contamination control within a GMP manufacturing environment, with leadership experience.
- Expertise in EU GMP Annex 1, ISO 14644, USP, PDA technical reports, and related regulatory frameworks for aseptic/low-bioburden manufacturing.
- Demonstrated expertise in barrier technology, with a focus on isolator systems, including design, qualification, operational requirements, and regulatory expectations.
- Fluent in English; additional European languages are a plus.
- Willing and able to travel internationally (approximately 20–30%).
- Data-driven with a track record of cross-site collaboration and driving improvements without direct authority.
- Strong interpersonal, verbal, and written communication skills across cultures and time zones.
- Hands-on experience with sterile fill-finish operations and cleanroom/facility qualification.
- Experience supporting GMP audits and inspection readiness activities.
About the Company
Merck
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Job Details
Employment Type
Full Time
Experience Level
Senior
Location
Darmstadt, DE
Posted
7 days ago
Country
DE