Play a key role in sterilization validation at Halden Pharma

Play a key role in sterilization validation at Halden Pharma

At Halden Pharma, we manufacture sterile pharmaceutical products for patients around the world. To support growing customer demand and exciting development projects, we are looking for a Validation Engineer - Sterilization to join our Validation & Qualification team.

In this role, you will play a key part in ensuring that our sterilization processes remain compliant, robust, and effective throughout their lifecycle. You will work closely with Production, QA, QC, Engineering, Regulatory Affairs, Supply Chain and customer project teams to support both ongoing operations and future investments.

This is an exciting opportunity for a validation professional who enjoys hands-on technical work, cross-functional collaboration, and working in a highly regulated GMP environment.

Your responsibilities:

• Lead and execute sterilization validation studies and report validated status
• Qualify new sterilization recipes and support implementation into manufacturing
• Perform periodic revalidation of sterilization processes
• Conduct periodic reviews of autoclaves and associated control systems
• Investigate and support deviation handling related to sterilization activities
• Plan, coordinate and execute validation activities in accordance with GMP requirements
• Prepare and review validation protocols, reports, risk assessments and other technical documentation
• Establish and maintain SOPs, templates and Validation Master Plans
• Coordinate FAT, SAT and commissioning activities for new systems and equipment
• Perform empty chamber mapping activities in new and existing autoclaves
• Support calibration activities for validation instrumentation
• Participate in customer audits and regulatory inspections
• Drive continuous improvement initiatives related to sterilization and validation processes