143 days ago on amecfw-row-external.icims.com

Lead Commissioning Qualification & Validation Engineer

Foster Wheeler Engineering AG

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Lead Commissioning Qualification & Validation Engineer

Lead Commissioning Qualification & Validation Engineer

Requisition ID 2015-8501
Work Location CH- Basel
Department / Discipline Commissioning, Maintenance, Operations & Validation
Additional Work Location ..
Position Type Staff / Permanent

Job Description

Overview / Responsibilities

Amec Foster Wheeler is currently recruiting for a Lead Commissioning Qualification & Validation (CGV) Engineer to be based in our Basel office in Switzerland. This will be a permanent position to work within our Validation group to support a number of projects in the pharmaceutical engineering sectors in this location.

The role could involve managing yourself, as well as being contracted to clients and working in a large team on projects from EUR 5,000 up to EUR 400m. The successful candidate will be happy working in an office and on site, whilst being compliant with Good Manufacturing Practice (GMP) in all cases. You will also be involved in acquiring projects, so some Business Development experience would be beneficial.

  • Providing Commissioning, Qualification and Validation (CQV) services to projects either independently or as part of a larger team
  • Generation of documents such as master plans, design, installation and operational qualification protocols, equipment, facility and utility protocols, cleaning validation, computer validation, sterilization validation, data reviews, SOP development and development of final reports, whilst leading others in similar activities
  • Extensive interaction with clients to identify CQV requirements and work towards solutions that meet schedule, cost, and quality expectations and requirements
  • Individual must be self-motivating, detail oriented, with superior skills in planning, organizing, and communicating CQV project tasks across a multidisciplinary team
  • Winning work via Business Development techniques with current and new clients
  • Leading teams of junior and senior engineers
Skills / Qualifications
  • BS or MS in engineering, computer sciences or life sciences, or equivalent work experience 
  • A minimum of ten years validation experience in the biotechnology and/or pharmaceutical industries required 
  • A thorough and working knowledge of Good Manufacturing Practice (GMP), GCPs, GLPs, GAMP and Part 11 compliance as they relate to qualification of systems and validation of processes.
  • Candidates must have excellent written and verbal communication skills, experience with Microsoft Word, Excel, Project, with hands-on experience working in a corporate setting
  • Ability to be a productive and supportive member of a project team, as well as working independently
  • Preferred candidates will have demonstrated validation experience in the following areas: manufacturing and utility systems, CIP & SIP, autoclave validation, qualification of controlled temperature environments, process validation, cleaning validation, equipment qualification, and use of the Validator 2000 and/or Kaye Digistrip.
  • A thorough knowledge of good documentation practices
  • Must have worked on projects utilizing advanced German and English language skills, whilst French language skills would be highly beneficial
Diversity Statement

We are an equal opportunity employer that recognises the value of a diverse workforce. All suitably qualified applicants will receive consideration for employment on the basis of objective criteria and without regard to the following (which is a non-exhaustive list): race, colour, age, religion, gender, national origin, disability, sexual orientation, gender identity, protected veteran status, or other characteristics in accordance with the relevant governing laws.


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