CQV Engineer

Vor 6 Tagen

Leverkusen, Nordrhein-Westfalen, Deutschland PharmEng Technology Vollzeit
Job Overview

PharmEng Technology is a global ISO certified Pharmaceutical Compliance Consulting Firm with projects around the world providing quality services to the manufacturers of pharmaceutical and health care products for over 25 years.

Our 300+ global consultants have expertise in Commissioning & Qualification, Validation, Quality Systems, Engineering, Medical Devices, Modular Cleanrooms, Thermal Mapping, Training, Toxicology and Regulatory Affairs.

PharmEng Technology is a cGMP compliant leader with international offices in Canada, Spain, France, Germany, Austria, Switzerland, Italy, Belgium, Singapore, Malaysia, Indonesia, Taiwan, Ireland, Denmark, Brazil and USA and maintains strategic partnerships for extended capabilities internationally.

PharmEng Europe is seeking a full-time experienced CQV Engineer in Leverkusen.

Key Responsibilities

  • Provide direct services to site Technical Services management, aiding to increase the throughput of commissioning and qualification activities through the department and across the site.
  • Perform activities related to commissioning, qualification, requalification, validation independently.
  • Commissioning, qualification, and requalification of new or existing manufacturing and laboratory equipment, facilities, services, and systems following regulatory guidelines such as GMPs or FDA.
  • Qualification of computerized and automation systems.
  • Writing of the corresponding qualification documents such as VP, IQ, OQ, PQ and PPQ protocols and reports, risk assessments, and development protocols.
  • Support for the development of user requirements and functional specifications.
  • Active participation in all phases of validation projects in accordance with the client needed.
  • Evaluation of projects and provision of technical information to others.
  • Recommendation to management as to the acceptance and release of qualified equipment/ facilities, services and/or systems.
  • Support for the generation and execution of all documentation related to demonstration batches, thermal studies, validation studies for equipment, engineering test runs, development studies.
  • Review of technical and quality system documents such as SOPs, Change Control, Deviation Reports, and Batch Production Records, ensuring any document changes meet quality and validation requirements and are in full compliance with regulations, standards, and regulatory compliance issues.
  • Technical assistance during investigations of process /equipment / cleaning / validation issues and aid in the resolution of validation deviations, protocol discrepancies and non-conformities.
  • Effective solutions for the management of system deviations and non-conformities through the CAPA System.
Requirements

Bachelor's degree in technical field (engineering, biology, chemistry, pharmacy).

At least 3 years of experience in QA Oversight for C&Q activities, in Biopharma or Pharma industry.

Generation and overview qualification documents like URS, System Risk Assessment, DQ, IQ, OQ, PQ, SOPs.

Hands on commissioning, qualification and validation experience in the following disciplines is needed:

  • Facilities (including clean rooms, HVAC)
  • Utilities (including WFI / RO/ purified water, clean steam, clean air, compressed air and gases, process waste systems)
  • Major qualification equipment
  • Process and cleaning validation
  • Equipment qualification
  • 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, ability to analyze data and reach appropriate conclusions, and to perform and appropriately document deviations and investigations.

Experience with Microsoft Office Suite.

Fluency in English and German is a must.

EU citizenship mandatory.

Benefits
  • Full-Time Position
  • Competitive Salary
  • Opportunities working for a global company.
  • Private Healthcare
  • Thirty (30) days Holiday
  • Continuous Professional Improvement including, but not limited to, courses or seminars.

At PharmEng Technology, we don't just accept difference — we celebrate it, we support it, and we thrive on it for the benefit of our employees, our clients, and our community. PharmEng Technology is proud to be an equal opportunity workplace.

We review all resumes and submissions, however, due to the sheer volume of requests that we receive, only successful candidates will be contacted.

Please, send your CV in English.

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