Commissioning Engineer

Panda International; Breda; On-site; EUR 55,000 - 75,000; Full time

Job summary

The CQV Engineer role at Panda International will support technical projects under minimal supervision and report to the Sr Manager Validation & Compliance within the site Engineering organization. You will develop, implement and report test strategies for technical solutions in accordance with internal customer requirements and standard CQV procedures.

Responsibilities include leading commissioning, qualification and validation activities; delivering guidance to the project group to ensure

Qualifications

• 3+ years in Commissioning, Qualification and Validation in pharma manufacturing.
• Experience with secondary packaging systems and printing/inspection equipment.
• Hands-on commissioning/qualification experience and validation documentation.

Responsibilities

• Develop and update validation documents and test protocols.
• Lead commissioning, qualification and validation activities.
• Provide guidance to project groups to align with validation plans and SOPs.

Skills

CQV experience

System commissioning

Documentation

Reporting

Tools

Systech

Cognex

Job description

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:

• o Develop and Update several Validation documents.
• E.g. System Level Criticality Assessments,
• Test Protocols,
• Requirement traceability matrixes
• Commissioning, Qualification and Validation summary reports
• o Lead Commissioning, Qualification and Validation activities
• o 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 Amgen SOPS

Basic Qualifications & Experience:

• 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.

Preferred Qualifications & Experience:

• 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.