Aseptic Cleanroom Training & Excellence Specialist
Geleen, Netherlands | Fully on site | 5-shift rotation
About the role
Our client is a leading global manufacturer of cell and gene therapies, and they are looking for several Aseptic Cleanroom Training & Excellence Specialists for their site in Geleen. Senior positions are also available for experienced candidates.
You will be the go-to expert for aseptic behavior on site. You make sure everyone working in the aseptic manufacturing areas has the knowledge, skills and habits to keep the highest standards of aseptic practice. You'll deliver hands-on training, coach people inside the classified areas and help keep improving training standards and procedures.
This is a chance to move from the cleanroom floor into a specialist role where you set the standard for the whole site.
What you will do
- Deliver and coordinate onboarding and GMP training on aseptic behavior and keeping the manufacturing environment aseptic
- Coach employees and contractors hands-on as they enter aseptic and classified areas, and support the aseptic behavior certification program
- Monitor aseptic practice, gowning technique and manufacturing activities to spot training needs, then coach or retrain where needed
- Analyse trends and develop training materials and improvement actions
- Support smoke studies, cleanroom management, and the training and monitoring of cleaning staff
- Produce reports and trend analyses for the Manufacturing and Quality Assurance teams
- Support deviation investigations, CAPAs, risk assessments and audits linked to microbial contamination and aseptic procedures
- Review equipment changes, process changes and new tools from an aseptic perspective, and support the procedure updates that follow
Must-haves (non-negotiable)
- Willing to work shifts
- Eligible to work in the Netherlands without sponsorship (visa sponsorship is not available)
What we are also looking for
- A BSc or equivalent in science or a related field
- Experience in a pharmaceutical, GMP or similarly regulated manufacturing environment
- Solid knowledge of aseptic behavior, sterile manufacturing practices and the relevant regulations (e.g. EU GMP Annex 1)
- Experience with electronic GxP training platforms (LMS), and with creating and delivering effective training materials
- Strong communication and coordination skills, and comfortable working with operators, contractors, Manufacturing and QA
- A self-starter with strong attention to detail, able to handle changing priorities
- Able to analyse trends and turn findings into practical improvements
What we offer
- A permanent contract
- A competitive salary based on experience, plus an attractive benefits package
- A dynamic, international and inclusive working environment
- Career development at a world-leading life sciences company
Interested?
Referrals are very welcome. We offer a referral bonus for every successfully placed candidate.