Head of Engineering and Technical Compliance | Head of Engineering&Technical Compliance (all genders)
Merck KGaA
Job Summary
This leadership role, based in Darmstadt, requires a Head of Engineering and Technical Compliance to spearhead the realization and operation of a highly innovative development pilot plant for sterile and solid dosage forms within the Global CMC Development unit of Healthcare. The successful candidate will lead a motivated expert team, ensuring technical compliance by managing validation, GMP adherence, technical changes, deviations, and CAPAs. Day-to-day activities include coordinating CAPEX projects, developing robust maintenance and calibration strategies, overseeing qualified service providers, and acting as the primary technical contact for operations. A crucial focus is placed on driving data integrity, automation, and cybersecurity within the digital plant environment. This position is ideal for an experienced leader with deep pharmaceutical industry knowledge who seeks to shape the future of drug development in a dynamic, global, and purpose-driven organization.
Required Skills
Education
Master's degree in Engineering or University degree in Pharmacy
Experience
- Minimum 5 years of experience leading employees in the pharmaceutical industry
- Professional experience focused on GMP, technical operational support, and technical compliance
- Demonstrated experience managing authority inspections and ensuring regulatory compliance
Languages
Additional
- Must maintain a clear focus on GMP standards; Role is based at the Darmstadt development site; Permanent contract
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