Pauwels Consulting
Pauwels Consulting, with head offices in Diegem and Ghent, is a fast-growing, independant and dynamic company with more than 100 employees. For over ten years Pauwels Consulting has been a loyal partner with expertise in IT, Engineering and Pharma for plenty of clients in Belgium, the Netherlands, Germany and France. In IT we offer global solutions with new technologies for application and web development, Business Intelligence and data warehouse. Our network and system engineers support our clients with our infrastructure services, helpdesk and support in different operating systems. In Engineering Pauwels Consulting is the number one partner for large (petro)chemical, industrial and production companies in Belgium and the Netherlands. We offer solutions for design, process, construction and supervision of specific projects. The consultants in our business unit Engineering Services can always be hired for solid support to industrial projects. Pauwels Consulting is also the perfect Pharma partner, not just for pharmaceutical and biotech companies, but also for their suppliers. Our consultants validate computer systems, processes, lab equipment and other specific applications. Our experts also provide on site quality control, audits and analysis, and GMP training and coaching and even product support. If so desired, we can set up projects from a to z (Special Projects). Pauwels Consulting’s strength lies in our consultants. Pauwels’ consultants are flexible and enthusiastic high potentials, and we are very happy to put our experience and expertise to work for the success of our clients.
Validation Supervisor Cold Rooms
Functieomschrijving
In the context of activities performed to maintain the validated status of computerised systems used to support vaccines production ensure proper execution of the periodic review methodology and application of cGMP (Validation Master Plan, Design Qualification, Installation & Operational Qualification, Performance Qualification and Validation Reports) and specific regulations applicable to the “computer” domain (such as FDA’s 21 CFR Part 11 or Eudralex Annex 11).
• Support the qualification process for cold rooms on a validation point of view according to the company standards
• Ensure the application of SOPs (such as Change Control, Incidents Management, Access Management, Backup and Restore,…) for the activities to coordinate
• Manage, schedule, coordinate and track each qualification or validation activitiy to ensure timely completion of the periodic review plan in coordination with Production, Technical, Quality Control, Quality Assurance and Regulatory departments
• Monitors that validation deviations are properly generated, managed and completed
• Coach the User, Technical Services, Validation and QA regarding the periodic review methodology applied to automated and analytical systems and the cold rooms qualifications
• Reports significant issues he identified to the Validation Manager he reports to
Profiel
Education
• University level (engineering, automation, IT,…) or equivalent by experience
Knowledge
• Bilingual French/English (spoken and written)
• Knowledge of main automation and IT principles and components (PLC, SCADA / DCS, HMI, network, …)
• Knowledge of process control part of standard automated and analytical equipments, such as
o Autoclaves
o Bio reactors / fermentors
o CIP / SIP
o Water loops
o HPLC
o ...
• Knowledge of metrology and instrumentation controls
• Knowledge of good practices in electronic records management
• Knowledge of risk analysis methods applicable to computerized systems (such as FMEA)
• Good knowledge of projects and qualification steps, including commissioning.
• Planning of activities
Experience
• Have already demonstrated success in implementing its discipline in minor or major projects.
• Over 2 years experience in process control validation
• Over 2 to 5 years experience in metrology and instrumentation control
• Good skills and competencies level in validation activities : organization, understanding and implementation of validation practices in projects, time schedule, team working,
• Coaching and communication skills
• Good knowledge in coordination of activities,
• Good expertise in GMP Practices (V cycle, GAMP)
• Ability to work under heavy pressure due to the requested flexibility and reactivity of the activities
• Autonomous
• Ability to work in project teams in a multidisciplinary environment and a matricial organization
• Quality oriented
Aanbod
- A position with responsability within a leading international company
- Personal development through learning on the job and additional external trainings
- A market oriented compensation, including a range of fringe benefits