Lead Commissioning Qualification & Validation Engineer (CQV)

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Lead Commissioning Qualification & Validation (CQV) Engineer

The role would involve 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.

* Provide Commissioning, Qualification and Validation (CQV) services to projects either independently or as part of a larger team

* Generate 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

* Interact with clients to identify CQV requirements and work towards solutions that meet schedule, cost, and quality expectations and requirements

* Win work via Business Development techniques with current and new clients

* Lead 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 10 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

* 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

* Individual must be self-motivating, detail oriented, with superior skills in planning, organizing, and communicating CQV project tasks across a multidisciplinary team

Sthree Switzerland is acting as an Employment Business in relation to this vacancy.