CSV engineer – Belgium

Introduction

Q-People provides targeted solutions in Quality and Compliance projects within Life Sciences, from Pharmaceutical and Biotech to API and Medical Device Production. Training, mentoring and coaching of talent within the Life Sciences sector is our strength. We don’t want specialist knowledge or talent to go to waste. WE PUT PEOPLE FIRST!

Our expert are active in:
1. Validation or qualification
2. Process engineering
3. Product development
4. Quality control projects
5. Quality assurance projects (analyst, project engineers)
6. Project Management in general

Organization

Q-People

Function

• Oversee and perform computer system validation activities and ensures the approach and execution aligns to directives and procedures.
• Perform technical checks on internal systems, verify that everything is stored correctly, perform fraud checks, etc.
• Write, review and execute computer validation documentation (Validation Plan, IQ, OQ, PQ, RTM, summary report).
• Provide input on improvement of testing documentation
• Support the implementation and adoption of the global CSV program and remediation. Support data integrity implementation and remediation for systems within CSV program.
• Participate in audits and continuous improvement efforts related to CSV program.
• Support the organization to achieve all CSV site and corporate goals.
• Work with IT to ensure that CSV packages are consistent with validation plans and standard operating procedures.

Requirements

• Bachelor’s Degree or Master in Engineering/IT/Science.
• Background in Lifesciences and/or Pharma/Biotech industries.
• Direct experience with IT and automation systems supporting GMP manufacturing.
• Fluent in French or Dutch AND English

Offer

– The opportunity to co-create the Q-People strategy;
– A career plan and an individual coaching;
– Challenges related to your expertise and ambition ;
– Being part of our community of Q-Consultants and benefit from advice and support from peers;
– Funny moments: team buildings, afterworks, events, etc. ;
– Our Q-Academy offers an broad training programme (hard&soft skills) to strengthen your knowledge and develop your skills;
– A permanent contract and an attractive salary package (13th month pay, hybrid car, petrol card, net allowance, meal vouchers, group insurance, hospital insurance, etc.).

Application

Ana Pardo Pons | Talent Partner
[email protected]
Place de l’Université 16 | Louvain-la-Neuve

 

Apply for this position

 

Apply

Return