Commissioning Engineer

Talentmark; Breda; On-site; EUR 50,000 - 70,000; Full time

Job summary

A leading engineering firm is seeking a Commissioning Qualification Validation Engineer in Breda, Netherlands. This role requires hands-on experience in commissioning and qualification within secondary packaging in the pharmaceutical industry. The successful candidate will develop validation documents, lead qualification activities, and deliver technical support to project groups. At least 3 years of relevant experience is essential, along with the ability to work independently. The position offers a full-time employment contract in a dynamic technical environment.

Qualifications

• At least 3 years' experience in executing commissioning, qualification, and validation in manufacturing organizations within the pharmaceutical industry.
• Experienced with secondary packaging systems, including print and inspection systems.
• Hands-on commissioning and qualification experience within secondary packaging operations.

Responsibilities

• Develop and update several validation documents including Criticality Assessments and Validation plans.
• Lead commissioning, qualification, and validation activities.
• Deliver technical support and guidance to project groups.

Job description

Commissioning Qualification Validation Engineer (GMP)

The CQV Engineer will support technical projects under minimal supervision and will report to Sr Manager Validation & Compliance within the site Engineering organization. The CQV Engineer will demonstrate hands on commissioning/qualification skills, including but not limited to the following: develop, implement, and report test strategies for technical solutions in accordance with internal customer requirements and standard CQV procedures. The CQV Engineer will drive the development of system commissioning qualification and validation documentation.

Key Responsibilities

Documentation:

• Develop and update several Validation documents (System Level Criticality Assessments, Validation, Commissioning, Qualification plans, Risk assessments, Test Protocols, Requirement traceability matrixes, Commissioning, Qualification and Validation summary reports)

Testing: Lead commissioning, qualification and validation activities. Technical support: Deliver guidance to the project group, ensuring the implementation follows the validation plan to meet internal customer requirements and company SOPs.

Qualifications & Experience

• Experienced with secondary packaging systems, including print and inspection systems (e.g., Systech, Cognex).
• At least 3 years’ experience in executing commissioning, qualification and validation within manufacturing organizations in the pharmaceutical industry.
• Experienced in Computerized Systems Validation.
• Hands‑on commissioning and qualification experience within secondary packaging operations.
• Ability to work independently and remotely with minimum direct supervision (a plus).
• Ability to anticipate, evaluate and resolve multiple, simultaneous project issues, delays and problems by utilizing technical and business expertise (a plus).

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Seniority level

• Associate

Employment type

• Full-time

Job function

• Biotechnology Research and Pharmaceutical Manufacturing