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Senior Commissioning Qualification & Validation Engineer

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Senior Commissioning Qualification & Validation Engineer

Requisition ID

2020-80513

Work Location

CH-Basel

Department / Discipline

Pharmaceuticals

Position Type

Staff / Permanent

Market / Sector (Candidate Portal Searching)

Pharmaceuticals
Overview / Responsibilities

Wood is currently recruiting for a Commissioning Qualification & Validation (CQV) Engineer to be based in our Basel office in Switzerland. to support a number of projects in the pharmaceutical engineering sector.

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.

Responsibilities:

  • 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
Skills / Qualifications
  • BS or MS in engineering, computer sciences or life sciences, or equivalent work experience 
  • Minimum 5 years’ qualification / 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
  • Mother tongue / fluent in German is a mandatory requirement
  • Fluent in English, 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
  • Eligible to work in Switzerland
Company Overview

Wood is a global leader in engineering and consultancy across energy and the built environment, helping to unlock solutions to some of the world’s most critical challenges. We provide consulting, projects and operations solutions in more than 60 countries, employing around 45,000 people. www.woodplc.com

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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