CQV Engineer

Vor 3 Tagen

Leverkusen, Nordrhein-Westfalen, Deutschland PharmEng Technology Vollzeit
About the Role

We are seeking a highly skilled CQV Engineer to join our team at PharmEng Technology. As a CQV Engineer, you will play a critical role in ensuring the quality and compliance of our clients' pharmaceutical and healthcare products.

Key Responsibilities
  • Provide direct services to site Technical Services management, aiding to increase the throughput of commissioning and qualification activities.
  • Perform activities related to commissioning, qualification, requalification, and validation independently.
  • Commission, qualify, and requalify new or existing manufacturing and laboratory equipment, facilities, services, and systems following regulatory guidelines.
  • Qualify computerized and automation systems.
  • Write qualification documents, risk assessments, and development protocols.
  • Support the development of user requirements and functional specifications.
  • Participate in all phases of validation projects, evaluating projects and providing technical information to others.
  • Recommend to management the acceptance and release of qualified equipment, facilities, services, and systems.
  • Support the generation and execution of documentation related to demonstration batches, thermal studies, validation studies, and engineering test runs.
  • Review technical and quality system documents, ensuring compliance with regulations, standards, and regulatory compliance issues.
  • Provide technical assistance during investigations of process/equipment/cleaning/validation issues and aid in the resolution of validation deviations, protocol discrepancies, and non-conformities.
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 the Biopharma or Pharma industry.
  • Generation and overview of qualification documents, such as URS, System Risk Assessment, DQ, IQ, OQ, PQ, SOPs.
  • Hands-on commissioning, qualification, and validation experience in facilities, utilities, major qualification equipment, process and cleaning validation, equipment qualification, and computer software validation.
  • Firm understanding of cGMP validation requirements/guidelines and familiarity with FDA regulatory requirements for the Pharmaceutical/Biopharmaceutical industry.
  • Proven capability to assess processes, equipment, and products for sources of variation, analyze data, and reach appropriate conclusions.
  • Experience with Microsoft Office Suite.
  • Fluency in English and German is a must.
  • EU citizenship is mandatory.
What We Offer
  • Full-Time Position
  • Competitive Salary
  • Opportunities working for a global company
  • Private Healthcare
  • Thirty (30) days Holiday
  • Continuous Professional Improvement

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