Validation and Commissioning Engineer

The Client 
Our client is a leading global biotechnology company that focuses on discovering, developing, manufacturing, and delivering innovative human therapeutics. The company's mission is to use advanced science and technology to address serious diseases, including cancer, cardiovascular conditions, and autoimmune disorders.

The Role

As a Validation and Commissioning Engineer, you will ensure that equipment and systems in pharmaceutical manufacturing are properly tested and meet safety and quality standards. You will create validation documents, lead testing, and support teams in following regulations to ensure compliance with GMP guidelines.

• Create and update validation, commissioning, and qualification documentation.
• Lead and execute commissioning, qualification, and validation activities.
• Perform risk assessments and develop requirement traceability matrices.
• Design and conduct test protocols to validate system performance.
• Provide technical guidance to ensure alignment with validation plans.
• Ensure all activities comply with GMP regulations and internal SOPs.
• Prepare detailed summary reports on commissioning, qualification, and validation outcomes.
• Address technical challenges and ensure timely project completion.
• Collaborate with internal and external teams to meet project goals.

Requirements:

• 3+ years of experience in commissioning, qualification, and validation in pharmaceuticals or manufacturing, including secondary packaging systems (e.g., Systech, Cognex).
• Hands-on experience in computerized systems validation with strong knowledge of GMP compliance and regulations.
• Proficient in creating validation documentation such as risk assessments, test protocols, and plans.
• Excellent technical writing, communication skills, and the ability to work independently with minimal supervision.
• Strong problem-solving, critical thinking abilities, and experience managing multiple projects while collaborating with stakeholders.

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