Process Engineer

The Company: A global pharmaceutical manufacturing organization focused on delivering high quality healthcare products within a highly regulated GMP environment. The company invests heavily in engineering excellence, validation, compliance, and continuous improvement to support complex manufacturing operations and ensure product quality and patient safety.

About the Role: The Commissioning Qualification Validation Engineer will support engineering and validation projects within a GMP manufacturing environment. This role focuses on developing and executing commissioning, qualification, and validation strategies for secondary packaging systems and computerized systems. The successful candidate will work independently while collaborating with project teams to ensure technical solutions comply with validation requirements, internal procedures, and regulatory standards.

Responsibilities: Develop and update validation documentation; Lead commissioning, qualification, and validation activities for manufacturing systems; Support validation lifecycle activities from design through implementation and qualification; Provide technical validation guidance to project teams; Ensure project deliverables comply with GMP requirements and internal procedures; Drive execution of validation strategies for secondary packaging equipment and computerized systems; Coordinate testing activities and review validation outcomes; Support additional projects and tasks assigned by management.

Requirements: Experience with Assembly and Secondary Packaging equipment qualification; Experience with Print and Inspection Systems such as Systech and Cognex; Minimum 3 years of hands on Commissioning, Qualification and Validation experience within pharmaceutical manufacturing; Experience in Computerized Systems Validation; Experience in CQV and HVAC CSV environments; Strong understanding of validation documentation and document hierarchy; Experience working within GMP regulated environments; Ability to work independently with limited supervision; Strong technical writing skills in English; Excellent communication and stakeholder management skills; Strong problem solving and critical thinking abilities; Ability to prioritize activities and manage multiple project deliverables.

Other Information: If you are interested and want to apply, please submit your application via the apply button below and contact me.