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:

As our Validation Engineer - Sterilization, you will:

• 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

What we are looking for:

• A BSc or MSc in Engineering, Pharmaceutical Sciences, Chemistry, Biology or a related scientific discipline

• Experience working with validation in a regulated industry

• Experience from pharmaceutical, medical device, biotechnology or other highly regulated manufacturing environments

• Knowledge of sterilization processes and validation methodologies

• Familiarity with EU GMP, FDA cGMP, ICH or ISO 13485 requirements

• Strong analytical and problem-solving skills

• The ability to work independently and collaboratively across departments

• Excellent written and verbal communication skills in both Norwegian and English

Why join Halden Pharma?

Halden Pharma is one of Northern Europe's largest and most advanced sterile manufacturing facilities. Our site combines a strong pharmaceutical heritage with a growing CDMO business, providing employees with the opportunity to work on diverse customer projects and advanced manufacturing technologies.

We offer:

• A challenging and meaningful role in an international pharmaceutical environment

• Opportunities for professional growth and development

• Collaboration with highly skilled colleagues across multiple disciplines

• Flexible working arrangements

• Excellent pension and health insurance schemes

• Access to company sports club activities and employee benefits

Ready to make an impact?

If you are passionate about validation, compliance, and ensuring the highest standards of patient safety, we would love to hear from you.

Apply through our career portal and become part of the team shaping the future of sterile pharmaceutical manufacturing at Halden Pharma.

Please contact department manager Anushya Gopal if you have any questions related to the position: Anushya.Gopal@halden-pharma.com