Requirements: English
Company: ALTEN Belgium
Region: Antwerp , Flanders
ALTEN Belgium is a leading consultancy company in the fields of Engineering, Life Sciences and IT in which our people and clients are central.
In our open and adaptable organization, we get the best out of our ambitious employees enabling them to perform optimally. We do this by offering them the most challenging projects, but also to continuously acquire new expertise to boost their careers. This can be done with the help of our ALTEN Academy, but also through our knowledge sharing events.
All employees together form a large network of expertise, even at an international level. In this way we offer optimal growth to our consultants and the best solutions for our customers.
- We are currently looking for a CSV Engineer to start on a project at one of our clients within the pharmaceutical industry in Flanders.
Main responsibilities:
- Act as Process Owner for local computer systems validation management.
- Maintain current Validation Master Plans; oversee timely execution.
- Review and approve CSV documentation (SOPs, user requirements, risk assessments, validation plans, test protocols, etc.) ensuring adherence to regulations, guidelines, and company policies.
- Collaborate with IT, engineering, and other departments to support new systems and process introductions, safeguarding cGMP standards.
- Contribute to cross-functional teams to meet shared objectives.
- Manage Change Control processes.
- Investigate and address deviations during qualification/validation activities, recommending corrective/preventive actions.
- Assess incidents related to computerized systems, determining product impact and escalating as necessary.
- Provide regular compliance reports and metrics.
- Prepare and coordinate system audits and inspectionsserving as CSV subject matter expert.
- Lead follow-up activities from audits, CAPAs, and quality system initiatives.
- Conduct internal and supplier audits, guiding teams toward compliance.
Main requirements:
- In-depth knowledge of cGMPs: 21 CFR Parts 11, 210, 211; EU Directives 75/319/EEC, 2003/94/EC; Annex 11, and related GMP guidelines.
- Proficiency with GAMP guidelines (particularly GAMP 5): risk-based validation approaches for GxP systems.
- Experience in software development, testing, and validation processes.
- Strong quality audit and software quality metrics expertise.
- Bachelors degree or equivalent in a relevant field.
- Fluent in English (written and spoken).
- Fluent in Dutch.
What ALTEN has to offer
- A permanent contract
- A salary package in line with your experience and extra benefits (meal vouchers, recovery days, insurances)
- The possibility to join a great team and be part of the success story of an international group
Apply now and be a part of our amazing journey. We believe in growing together!
We are looking forward to getting to know you and your ambitions!