Validation Engineer - Drive Excellence in Pharma Validation

Halden Pharma is seeking a skilled and motivated Validation Engineer to join our Technical Department. In this role, you will be an integral part of a cross-functional team, ensuring that our validation and qualification processes meet the highest industry standards. You will work in a fast-paced, dynamic environment where your expertise will help drive key projects and improve processes across multiple departments, including QC, Production, Supply Chain, Engineering, and Regulatory Affairs.

Purpose of the Role:
As a Validation Engineer, you will focus on process and equipment validation, ensuring that Halden Pharma meets regulatory and customer requirements. You will collaborate closely with project teams and stakeholders, managing tasks related to qualification, process validation studies, and equipment qualification. Additionally, you will help harmonize activities across departments and actively contribute to continuous improvement initiatives.

Key Responsibilities:

• Conduct process validation studies and provide validation status reports.
• Qualify equipment and report the validated status.
• Approve validation activities for various projects and tasks.
• Author and/or lead studies for process validation and equipment qualification.
• Prepare validation plans and protocols, including the definition of acceptance criteria.
• Perform testing and participate in inspections and audits with government and customers.
• Ensure that all activities adhere to company policies, regulatory requirements, and customer agreements.
• Assist with preparation for audits and regulatory inspections.

Main Tasks:

• Manage validation activities for production equipment, utilities, and cleanroom environments.
• Ensure all qualification activities comply with company policies, procedures, and legal/regulatory standards.
• Develop SOPs, templates, and update Validation Master Plans.
• Coordinate and execute all qualification phases, including FMEA, DQ, IQ, OQ, PQ, and qualification protocols.
• Collaborate with internal teams and external partners to execute FAT, SAT, and commissioning of new manufacturing systems.
• Support audits and inspections to ensure compliance with regulations.

Qualifications:

• Master's degree or equivalent in Engineering, Chemistry, Biology, Pharmacy, or a related field.
• Previous experience in a similar role within a regulated industry (preferably medical device or pharma), or in other industries with relevant legislative regulations.
• Experience with EU or FDA cGMPs (21 CFR Part 211, 21 CFR Part 820), ICH Q7, EU GMPs, or ISO 13485 is preferred.
• Strong analytical and problem-solving skills with the ability to assess complex systems.
• Excellent communication and interpersonal skills, with fluency in English (Norwegian proficiency is a plus).
• Ability to work independently and collaborate effectively with cross-functional teams.

What We Offer:

• Career Development: Opportunities for continuous professional growth and development in an international environment.
• Meaningful Work: A role that plays a crucial part in ensuring safe and effective pharmaceutical products for global markets.
• Inclusive Environment: A collaborative and supportive work culture with an international team.
• Employee Perks: Access to corporate cabins for leisure, as well as participation in a company sports team and wellness initiatives.

If you are ready to be part of a dynamic, innovative company that places high value on quality and professional growth, we would love to hear from you!

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

Applicants will be considered on an ongoing basis.