CCRM Nordic AB (svb)
Sweden, Mölndal
ABOUT CCRM NORDIC
CCRM Nordic exists to accelerate the development and manufacture of life-changing advanced therapies. Based at GoCo Health Innovation City in Mölndal, we support ATMP innovators across the Nordics and Europe with GMP manufacturing expertise, process development and scalable manufacturing solutions.
As part of our continued growth, we are establishing a brand-new, state-of-the-art GMP manufacturing facility at GoCo House, purpose-built for advanced therapy medicinal products and next-generation bioprocessing. The facility includes multiple dedicated processing rooms, modern cleanroom environments and cutting-edge manufacturing technologies supporting a growing portfolio of clinical-stage programmes.
Joining CCRM Nordic at this stage means becoming part of an expanding GMP manufacturing team within a newly established facility focused on advanced therapy manufacturing.
THE OPPORTUNITY
We are looking for an experienced and hands-on Senior Process Engineer to support GMP manufacturing activities within our new state-of-the-art manufacturing facility.
In this role, you will work closely with Manufacturing, MSAT, Validation and Quality teams to support clinical manufacturing, technology transfer and continuous improvement activities for advanced therapy products.
This role is ideal for someone who enjoys hands-on GMP manufacturing in a fast-paced ATMP environment and is motivated by technical problem-solving, collaboration and continuous improvement.
KEY RESPONSIBILITIES
GMP Manufacturing & Process Support
Support day-to-day GMP manufacturing activities for Phase I and II clinical materials, performing operations within Grade B/C cleanrooms and Grade A isolators while maintaining strict aseptic standards.
Perform hands-on cell culture and bioprocessing activities, including operation and troubleshooting of manufacturing equipment such as bioreactors, centrifuges, incubators, TFF and chromatography systems.
Support technology transfer activities and the introduction of new products and processes into the GMP manufacturing suite.
Quality, Compliance & Continuous Improvement
Ensure manufacturing activities are performed in accordance with GMP requirements, approved SOPs and batch documentation. Support deviation investigations, CAPAs, change controls and audit readiness activities.
Contribute to process optimisation and technical lifecycle management initiatives aimed at improving manufacturing performance and operational efficiency.
Support equipment qualification and validation activities, including authoring technical documentation such as SOPs, batch records, logbooks and User Requirement Specifications (URSs).
Collaboration & Team Development
Train and mentor junior colleagues in GMP operations, aseptic techniques and cleanroom behaviour. Work closely with colleagues across Manufacturing, Quality, Validation and Process Development to support efficient and compliant GMP manufacturing operations.
WHAT WE ARE LOOKING FOR
Essential
Minimum 3 years’ experience working in GMP manufacturing within the pharmaceutical or biotech industry
Hands-on experience in bioproduction, ATMPs or cell therapy manufacturing
Experience working in GMP cleanroom environments, ideally Grade B
Strong knowledge of GMP compliance and quality systems
Experience with cell culture techniques
Scientific, pharmaceutical or related life science degree
Strong communication skills and the ability to collaborate across functions
Desirable
Experience with aseptic process simulations or aseptic filling
Experience working with isolators
Experience supporting technology transfer or validation activities
THE PERSON
We are looking for someone who is collaborative, adaptable and motivated by building something new. You are hands-on, quality-focused and comfortable working in a dynamic GMP environment where priorities can evolve quickly.
You are:
A strong team player with a proactive mindset
Calm and solution-oriented under pressure
Organised and able to manage multiple priorities simultaneously
Detail-oriented, with high standards for quality and compliance
Motivated by continuous improvement and operational excellence
WHY JOIN CCRM NORDIC?
Joining CCRM Nordic means becoming part of an innovation-led organisation at the forefront of ATMP development and manufacturing. This is an exciting opportunity to work within a newly established GMP manufacturing facility supporting the production of advanced therapies for clinical programmes.
Ready to help build the future of advanced therapy manufacturing? We’d love to hear from you.
Zamieszczone 1 tygodni/e temu