CSV C&Q Engineer

To support an on site project for a client in the pharmaceutical sector in the region of Brussels we are searching for a CSV C&Q engineer (medior level).

PM Group is a leading International engineering, architecture, project and construction management firm. With a network of offices in Europe, Asia and the US and a multi-discipline team of more than 3,700 people, we deliver complex, capital projects in the life sciences, food and beverages, mission critical/ICT, advanced manufacturing, energy and environmental sectors.

Our Vision is to be a highly valued and creative delivery partner, building a more sustainable world with our clients.

Our OTS (Outsourced Technical Services) department supports projects in different sectors on basis of project staffing with consultants working at the client’s site.

As CSV Commissioning and Qualification (C&Q) engineer, and as part of an integrated team,
you will act as a CSV C&Q Subject Matter Expert providing expertise and Lead the CSV C&Q portion
of the project to ensure the C&Q activities are completed safely, as per schedule and in compliance
with the system requirements, specifications and project procedures/ guidelines.

Key Responsibilities:

• Act as CSV C&Q Subject Matter Expert and Compliance lead for CSV. Ability to provide guidance to
  supplier and the rest of the UCB team in all CSV C&Q activities for the system(s), from design to field
  execution and to summary report approval.
• Lead the CSV C&Q strategy based on CSV VMP
• Draft or provide technical guidance on document drafting by partner/ supplier or UCB team,
  coordinate review and approval of applicable CSV C&Q documents (requirements, testing, reporting)
  following approved VMP and SLIA.
• Drive correct CSV verification testing, compliance and acceptance. Conduct troubleshoot, deviation
  investigation and resolution for problems and issues encountered during execution activities. E.g.
  software module and configuration updates during SFAT and IOV testing.
• Generate and or review change controls related to CSV C&Q and drive closure in a timely manner
• Ensures all personnel who perform C&Q activities for the system(s) have relevant training assigned.

• 3 years experience in International CAPEX Commissioning and Qualification.
• Knowledge of software: HPLC, chromatography (inpower, Softmaxpro)
• IT Background is OK; knowledge of PLC or SCADA is not mandatory
• Technical qualification at third level or equivalent in Engineering.
• Extensive knowledge and demonstrated experience delivering CSV Commissioning and Qualification
  for Pharmaceutical / Biotechnology projects.
• Strong understanding of a risk-based approach to CSV commissioning and qualification within the biotechnology industry. Experience with ISPE best practice / GAMP-5/ Anex 15 GMP EU/ Eudralex . Annex 1, ASTM E2500/ electronic execution.
• Experience of sterile / biotech / single use equipment in the bio-pharmaceutical industry is preferred.
• Knowledge of safety, GMP and environmental regulatory requirements.
• Ability to make decision under pressure and demonstrated strong Communication/ Leadership skills.
• Demonstrated ability to collaborate with senior stakeholders to achieve optimal outcomes
• Language : French and English (English mandatory)

Why PM Group?

As an employee-owned company, we are inclusive, committed and driven.  Corporate Responsibility and Sustainability are the heart of our new 2025 business strategy. Click HERE to read more in our ‘Corporate Responsibility and Health, Safety and Wellbeing Report’.

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