Job title: Commissioning & Qualification Manager
Company: Wood Group
Job description: Wood is currently recruiting an experienced Commissioning Qualification & Validation (CQV) Manager to be assigned to a Large Biotech project for a new plant in Germany. The project is currently in the construction phase with a forecasted starting date for commissioning activities.
The role involve planning and managing all commissioning and qualification activities, coordinating resources from Wood, customer and contractors. Size of the CQV team is anticipated to be in the range of 50 people. C&Q protocols are being developed at the moment. Reports to Wood Project Director.
AUG employment contract is required.
- Finalize Commissioning, Qualification and Validation (CQV) strategy and execution plans for all site activities
- Being the point of contact for both Wood and the Client for all CQV related matter
- Actively work with site Wood safety team to ensure that C&Q operations are executed in safe manner
- Be accountable for schedule, costs and customer quality expectations
- Coordinate commissioning and qualification engineers, personnel provided by contractors as well personnel from vendors of complex equipment / packages
- Support the finalization of the necessary documentation / protocols to be used during site activities
Skills / Qualifications
- BS or MS in engineering, computer sciences or life sciences, or equivalent
- A minimum of 10 years’ site commissioning and validation experience in the biotechnology and / or pharmaceutical industries required
Involvement in large Capex projects with Long Terms Project contracts
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
- A thorough knowledge of good documentation practices
- Must have worked on projects utilizing advanced English language skills; knowledge of German would be an asset
- Individual must be self – motivating, able to lead and manage large team in a complex set up, with superior skills in planning, organizing, and communicating CQV project tasks across a multidisciplinary team
- Owing a work permit for Germany
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.
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.
Location: Ulm, Baden-Württemberg
Job date: Fri, 29 Jan 2021 03:50:51 GMT
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