SME Critical Utilities
HP Halden Pharma AS
- Frist 21.9.2025
- Ansettelsesform Fast
Join Halden Pharma as SME for Critical Utilities!
Halden Pharma is now looking for a SME Critical Utilities - a senior role combining deep technical expertise with project leadership in a growing international CMO.
This is a key position with significant impact, where you will be responsible for maintaining and developing our critical utility systems.
About the role
As SME for Critical Utilities, you will have a dual focus:
Act as the company's subject matter expert, ensuring that our critical utility systems (water, steam, gases, compressed air, etc.) are reliable, compliant and future-ready
Lead and support strategic projects, driving improvement, technology transfer and new system implementations
Your main responsibilities will include:
Following up on GAP assessments and implementing new regulatory requirements
Establishing and maintaining control strategies for critical clean utilities
Keeping risk assessments up to date and ensuring mitigating actions are implemented
Supporting change control with impact and risk assessments
Leading or supporting technical projects related to development and technology transfer
Representing Halden Pharma in internal and external audits within your field of expertise
Who are we looking for?
We are looking for an experienced engineer who enjoys combining deep technical knowledge with hands-on project execution. You likely bring:
MEng or equivalent degree in engineering - mechanical, chemical, or process discipline
Minimum 5 years of experience in an engineering role within pharma, food, process, or other regulated industries
Solid knowledge of GMP requirements, regulatory frameworks and relevant standards (e.g. ISO)
Strong analytical skills, structured mindset, and ability to translate complexity into clarity
Excellent communication skills in English - our working language. Proficiency in a Scandinavian language is an advantage
In addition, we value:
Clear and confident communication - both operationally and strategically
Proven project leadership - with the ability to plan, coordinate and deliver
Change management experience - helping modernize and improve established functions
A digital mindset - with interest in monitoring systems, data analytics and automation
Sustainability awareness - contributing to energy optimization and reduction of water use and emissions
Mentoring skills - supporting knowledge transfer to younger engineers
You thrive in a dynamic environment where collaboration, compliance and innovation go hand in hand. You are confident in your expertise, yet curious and open to continuous improvement.
What we offer:
A strategic specialist role in a fast-growing international CMO
The opportunity to further develop a function that is critical to our operations
A diverse and international workplace with colleagues from over 40 nationalities
A culture built on collaboration, high standards and strong professional pride
Opportunities for both personal and professional growth
Please contact John David Wall if you have any questions related to the position: John.Wall@halden-pharma.com
Applicants will be considered on an ongoing basis.
FerdigheterAI-generert
- Endringshåndtering
- Gap analysis
- GMP (Good Manufacturing Practice)
- Ingeniørarbeid
- Kjennskap til kvalitetsmessige myndighets- / produktkrav
- Regulatory compliance
- Risikostyring
JobbMatch
BetaEr du kvalifisert for jobben?
Nysgjerrig på om du kvalifiserer til denne jobben? Med JobbMatch får du umiddelbar tilbakemelding på hvor godt din profil matcher stillingsutlysningen.
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 «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
- Sektor: Privat
- Sted: Svinesundsveien 80, 1788 Halden
- Bransje: Drift og vedlikeholdstjenester, Farmasi og legemiddel, Industri og produksjon
- Stillingsfunksjon: Ingeniør, Ledelse
Nøkkelord
pharma, GMP, project lead, production
(1/2)
Annonseinformasjon
- FINN-kode 425405249
- Sist endret