Join Our Team as a Validation Engineer - 18-Month Temporary Position

Halden Pharma is seeking a skilled and motivated Validation Engineer to join our QC Validation and Compliance Department for a temporary 18-month assignment. In this role, you will play a key part in ensuring compliance with regulatory standards by validating analytical methods, qualifying laboratory instruments, and supporting quality control processes.

If you have a background in analytical method validation, chromatography systems, and GMP regulations, and thrive in a structured and dynamic environment, we encourage you to apply.

Purpose of Position:
Analytical method validation, verification, co-validation, method transfer.
Qualification and implementation of analytical instrument into QC laboratory.

Responsibilities / Duties

• Validation, verification, co-validation, method transfer and implementation of analytical methods for new and existing finish products / raw materials.
• Creation and review of all relevant quality documents in compliance with current pharmacopeias and GMP regulation (SOPs, protocols, reports and specifications and etc.)
• Qualification and implementation of the new analytical instruments.
• Training of laboratory personnel in new analysis methods or instruments.
• Change control execution, event handling and CAPA/ action management processes in compliance with the global QM.
• Representation of department during external audits.

Qualifications

• Education from university in Chemistry/ Biotech/ Pharmacy equivalent to Bachelor/Master or/and experience from equivalent position.
• Experience within chromatography systems and different analytical techniques is an advantage.
• Knowledge and experience in Quality Control, Validation, Pharmaceutical industry, regulatory guidelines and regulations, Good Manufacturing Practice/21CFR part 11/Annex 1/GAMP5 is an advantage.
• Fluency in English, both written and spoken, is required; proficiency in Norwegian is an advantage.

Personal characteristics

• Organized and quality oriented.
• Proactive and goal oriented.
• Positive mind-set and an including attitude.
• Ability to work in a structured, systematic and dynamic environment.
• Good communication- and cooperation skills.
• Ability to work independantly.

What We Offer:

• An opportunity to be part of an innovative and growing organization.
• A supportive and inclusive work environment.
• Professional development opportunities.

Join us in shaping the future of pharmaceutical quality standards!

Please contact Laima Kasiulis if you have any questions related to the position.

Applicants will be considered on an ongoing basis.