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THThermo Fisher Scientific Inc.

Senior CQV Engineer(m/w/x)

Lengnau
Full-timeOn-siteSenior
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Preparing, reviewing, and approving validation documents and audit responses for GMP systems. Bachelor's degree in a technical field and 3+ years of pharmaceutical validation experience required. Collaboration with Quality Assurance and System Owners.

Requirements

  • Bachelor’s degree in Biotechnology, Quality, Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or related field
  • Master's degree or Bachelor's degree + 3 years in engineering, preferably in pharmaceutical or chemical process industry
  • Functional knowledge of cGMPs and manufacturing operations in FDA regulated facility
  • Experience in pharmaceutical industry for qualification & validation
  • Experience in multi-cultural work environment
  • Excellent verbal and written communication skills in English
  • Preferably German or another European language
  • Strong understanding of GMP standards and regulatory requirements
  • Excellent technical writing skills with attention to detail
  • Proficiency in PC applications, including MS Office
  • Strong communication and interpersonal skills
  • Certification in technical writing or quality management
  • Experience with electronic documentation management systems (e.g., Documentum, TrackWise)

Tasks

  • Prepare, review, and approve production, validation, audit reports, documents, procedures, and rationales
  • Evaluate new regulations, changes to existing regulations, and regulatory trends
  • Prepare inspections and customer audit responses and reports
  • Perform gap analysis to resolve inefficiencies and take appropriate actions
  • Define requalification strategy for GMP systems in collaboration with Quality Assurance and System Owners
  • Implement requalification strategy, including maintaining the quality system and completing practical activities
  • Coordinate execution of activities by external contractors
  • Perform requalification and revalidation Work Orders, including routine and non-routine operations
  • Document requalification and revalidation activities in forms and OMX following Good Documentation Practices
  • Participate in the culture of continuous improvement and development of technologies
  • Identify training needs and develop training programs
  • Work in a safe and responsible manner to build an injury-free and incident-free workplace
  • Participate in calibration activities

Work Experience

  • 3 years

Education

  • Bachelor's degreeOR
  • Master's degree

Languages

  • English – Native
  • German – Basic
  • Basque – Basic

Tools & Technologies

  • MS Office
  • Documentum
  • TrackWise
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Thermo Fisher Scientific Inc. and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.

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