Our client operates in a regulated manufacturing environment where digital systems play a critical role in production and quality assurance. To support ongoing system implementations and upgrades, they are looking for an experienced quality professional with a strong background in Computer System Validation and Manufacturing Execution Systems.
Job Description
As a Senior Quality Engineer focused on Computer System Validation, you will support multiple MES-related initiatives by acting as a quality authority for system qualification and validation activities. You will work closely with engineering, operations, and quality colleagues to ensure that computerized systems meet regulatory expectations and site standards. The role requires independent execution of validation oversight, combined with collaboration on complex projects and continuous improvement efforts.
Responsibilities
- Provide quality oversight for MES qualification and validation activities across multiple projects
- Review and approve validation documentation for initial implementation, system updates, and periodic revalidation
- Apply risk‑based approaches to system validation and quality decision‑making
- Support the development and monitoring of KPIs to drive process improvements
- Contribute to change implementation strategies for systems and processes
- Ensure compliance with GMP and other applicable quality regulations
- Support CQV oversight and Quality Risk Management activities
- Collaborate with operational teams during audits, inspections, and process reviews
- Identify quality issues, assess impact, and support resolution of complex deviations
Requirements
- Bachelor's degree in a scientific, engineering, or related field
- Strong experience applying quality engineering principles within regulated environments
- Proven Computer System Validation expertise
- Mandatory experience with Werum PAS‑X (MES)
- Excellent communication skills, including technical writing
- Ability to work independently while aligning with team and departmental objectives
- Preferred: familiarity with Six Sigma or DMAIC methodologies
- Preferred: experience with risk assessment tools such as FMEA or HACCP
Benefits
- Start via Oxford Global Resources for the first year
- Estimated salary: €6900 gross per month
- Region: Amsterdam area
- Working hours: Monday to Friday, standard office hours (09:00-17:00)
- Involvement in high‑impact digital projects, cross‑functional collaboration, and opportunities to further specialize in MES and CSV
- Vacancy number: 27192
