Senior Validation Engineer

Vor 3 Tagen


Leverkusen, Nordrhein-Westfalen, Deutschland PharmEng Technology Vollzeit

We are seeking a highly experienced Senior Validation Engineer to join our team in Leverkusen.

Job Overview

The ideal candidate will have a strong background in commissioning, qualification, and validation of pharmaceutical equipment and systems. The selected individual will be responsible for providing direct services to site Technical Services management, aiding to increase the throughput of commissioning and qualification activities through the department and across the site.

  • Will be expected to perform activities related to commissioning, qualification, requalification, validation independently.
  • Familiarity with cGMP validation requirements and FDA regulatory guidelines is essential.
  • This position requires availability to travel.
Key Responsibilities
  • Commissioning, qualification, and requalification of new or existing manufacturing and laboratory equipment, facilities, services, and systems following regulatory guidelines.
  • Qualification of computerized and automation systems.
  • Writing of qualification documents, including VP, IQ, OQ, PQ, and PPQ protocols and reports.
  • Providing technical assistance during investigations of process/equipment/cleaning/validation issues.
  • Recommending to management as to the acceptance and release of qualified equipment/facilities/services/systems.
Requirements
  • Bachelor's degree in a technical field (engineering, biology, chemistry, pharmacy).
  • At least 3 years of experience in QA Oversight for C&Q activities in Biopharma or Pharma industry.
  • Strong understanding of cGMP validation requirements and familiarity with FDA regulatory guidelines.
  • Familiarity with Microsoft Office Suite.
  • Fluency in English and German.
  • EU citizenship mandatory.
What We Offer
  • Competitive salary: €80,000 - €100,000 per year.
  • Opportunities working for a global company.
  • Private healthcare.
  • Thirty (30) days holiday.
  • Continuous professional improvement.

At PharmEng Technology, we value diversity and inclusion. We are committed to creating an environment where everyone feels valued and respected. If you are a motivated and experienced engineer looking for a new challenge, please submit your application.



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