Overview
We are looking for Intermediate to Senior CQV Engineer who will bring their expertise with them and drive a number of Capex projects to completion.
This role could be based either in the Netherlands or at our locations in Bornem or Waterloo in Belgium.
Who we are
PM Group is an employee owned, international project delivery firm with a team of 3,600+ people. We are world leaders in the pharma, food, biotech, medical technology and mission critical sectors. From our network of offices in Europe, Asia and the US, we work with the world's leading organizations. We are focused on growing a sustainable business centered on our people, our clients and trade partners.
Responsibilities
* Performs commissioning, qualification, and validation testing on utilities and manufacturing process equipment and instruments under the CQV manager’s direct or indirect supervision
* Authors plans and protocols
* Initiates controlled documentation in support of CQV projects as part of a team
* Develops documents such as master plans, design qualification, equipment, facility and utility commissioning and final reports
* Interacts with clients to identify CQV needs and work toward solutions that meet schedule, cost, and quality expectations and requirements based on Good Engineering Practices
* Follows project planning, management and execution schedules
* Reviews equipment specifications, manuals, and develops an understanding of how instruments work; tests equipment accurately to meet requirements for intended use
* Investigates failures and deviations; creates reports
* Analyses and reviews spare parts lists to ensure they are fit for purpose
* Reviews engineering drawings for accuracy and acts to correct errors
* Performs system walk-downs and makes changes using the change control of processes
* Assists with Corrective and Preventative Actions (CAPAs) and makes recommendations to resolve deficiencies
* Creates summary and analyses reports
* Creates and maintains job plans, maintenance schedules and PMs
* Understands scope change and identifies scope change to supervisors for resolution
Qualifications
* Clear understanding of cGMPs and pharmaceutical operations
* A minimum of 3 years’ experience in CQV
* Understands and is able to apply principles of commissioning and qualification.
* Good analytical, organizational, time management and problem-solving skills.
* Good writing skills. Able to develop and execute DQ, FAT, SAT, OQ, PQ, develop SOPs, create final reports and author validation and quality policies, procedures and guidelines under direct or indirect supervision of the Senior engineering team.
* Basic understanding of working in a construction environment and possess basic understanding and knowledge to apply current industry guidelines, standards and safety requirements
* Ability to read and interpret P&IDs and identify boundaries
* Working knowledge of and ability to apply GMP, GCP, GLP, GAMP
* Proficient with Microsoft Word, Excel, PowerPoint, Visio and Project
* Hands-on experience working as a productive and supportive member of a project team
* Possesses validation experience.
* Detail oriented. Completes work tasks and documentation with minimal errors
* Ability to work independently or on a team
* Excellent command of English and preferably Dutch and/or French
What you will get:
Opportunities to work in interesting and challenging projects for international client organizations, while working in a multi-disciplinary environment, in a vibrant expanding international company.
All of your information will be kept confidential according to EEO guidelines.
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.
Inclusion and Diversity are core to our culture and values. Wherever we work, we commit to a culture of mutual respect and belonging by building a truly inclusive workplace rich in diverse people, talents and ideas. Valuing the contributions of all our people and respecting individual differences will sustain our growth into the future.
PM Group is committed to ensuring our hiring process is fair and accessible to all and will provide candidates with disabilities with reasonable accommodations required to participate in the recruitment process. If you require any assistance in this regard, please let us know.
#LI-EB1
RECRUITMENT AGENCIES NEED NOT APPLY