Senior QC Validation Engineer - Analytical Methods & GMP Compliance

Are you an experienced validation professional looking to work in a highly regulated and advanced pharmaceutical environment?

At Halden Pharma, we are strengthening our QC Validation and Compliance team and are now looking for a Senior Validation Engineer / Specialist to play a key role in ensuring quality, compliance, and robustness of our analytical methods.

This is a unique opportunity to join a specialized pharmaceutical manufacturing company where you will work closely with experts across QC, QA and production - and contribute directly to delivering medicines to patients.

About the role:

In this position, you will support the team within analytical method validation and play a central role in method transfers, implementation and lifecycle management.

You will work in a dynamic environment with a high level of cross-functional collaboration and exposure to both internal stakeholders and external partners.

Key responsibilities:

• Lead method transfer, validation, verification and implementation within the QC Chemistry Laboratory

• Author, review and approve analytical methods and related documentation

• Review and approve specifications for raw materials and packaging materials in line with pharmacopeial and GMP requirements

• Collaborate with external laboratories, including contract setup and approval of transfer protocols and reports

• Prepare and approve key quality documentation (SOPs, protocols, reports, risk assessments, specifications)

• Ensure timely implementation of pharmacopeia updates and verification of compendial methods

• Support organization within analytical validation field providing scientific and regulatory expertise

• Execute change control, handle deviations and drive CAPA processes in line with the Quality Management System

• Represent the department in audits and interactions with customers and regulatory authorities

Who we are looking for:

We are looking for someone who combines strong technical expertise with a pragmatic and collaborative mindset.

Qualifications:

• Master's degree (or equivalent) in Chemistry, Pharmacy, Biotechnology, Microbiology or other related field

• Experience from Quality Control in the pharmaceutical industry

• Knowledge of USP and Ph. Eur. is an advantage

• Experience with multiple analytical techniques

• Familiarity with regulatory guidelines such as ICH Q2 (R2), ICH Q14 and EU GMP Annex 1 is beneficial

Personal qualities:

• Structured and quality-focused, with the ability to manage complex tasks

• Proactive and solution-oriented, with a drive to deliver results

• Strong collaboration skills and ability to work across functions and cultures

• Clear and confident communicator in English (written and verbal)

• Takes ownership and demonstrates sound judgment within area of expertise

Why join Halden Pharma?

• Work in a highly competent and collaborative environment

• Be part of a company with advanced manufacturing technologies and strong growth ambitions

• Opportunity to influence and shape validation practices in a regulated setting

• International work environment with exposure to global customers and partners

HP Halden Pharma AS, strategisk plassert ved Norges største innfartsåre, er en av de største og mest avanserte sterile produksjonsfasiliteter i Nord Europa.

Dette «state-of-the-art» anlegget produserer IV poser, plastampuller og vials ved hjelp av en «blow-fill-seal» teknologi og andre farmasøytiske doseringsformer.

Anlegget var ikke bare en hjørnesteinsbedrift for den tidligere eieren Fresenius Kabi i Norden, men henvender seg allerede til andre fremtredende farmasøytiske kunder som kontraktsprodusent.

I Norge, har vi nå et anlegg i Halden med rett over 650 medarbeidere.

For mer informasjon, vennligst se vår hjemmeside: halden-pharma.com