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
Om arbeidsgiveren:
HP Halden Pharma AS, strategisk plassert ved Norges største innfartsåre, er en av de største og mest avanserte sterile produksjonsfasiliteter i Nord Europa.
Dette <> anlegget produserer IV poser, plastampuller og vials ved hjelp av en <> 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 over 650 medarbeidere.