Engineer (35278)

Orion Group Life Sciences are looking for an Engineer (CQV Engineer) for our Multinational Pharmaceutical/Biotechnology client based in Breda. Initial 12-month contract, with high possibility of extension. This is a fully onsite position. When the work allows it, could be 3 days onsite.

Role Summary

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.

Main Responsibilities of the role

• Documentation:
  • Develop and Update several Validation documents.
    • g. System Level Criticality Assessments.
    • Validation Plans.
    • Commissioning Plans.
    • 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, so the implement technical solution follows the validation plan in order to achieve meeting internal customer requirements, and accordance with the SOPS of our client.

Required Qualifications

• Experienced with Secondary Packaging Systems, including experience with 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 industries.
• Experienced in Computerized Systems Validation.
• Hands on commissioning and qualification experience within Secondary Packaging Operations.
• Good understanding of the role of a single document within the bigger picture.
• Internal and /or external reporting relationships.
• Ability to work independently and remotely with minimum direct supervision.
• Good English Technical Writing.
• Excellent communication skills.
• Customer relationship management skills.
• Critical thinking skills.
• Able to set clear priorities and escalate to ensure timely delivery of the project phases including design, development, implementation, testing, construction, commissioning, and validation.
• Experience within a GMP compliance environment regarding practices, policies, procedures, legal requirements and goals of project, develop supporting documentation and monitor activity timeliness / scheduling.
• Ability to anticipate, evaluate and resolve multiple, simultaneous project issues, delays and problems by utilizing technical and business expertise.

If you would like to have a confidential conversation regarding this opportunity please reach out to Tim Browaeys, tim.browaeys@orion-jobs.com or contact Tim on 0044 7593448607

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