Cytiva

Biotechnology

QualityEngineer

€58–82k ~AI est. Medemblik, North Holland, Netherlands FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Mid candidates.

The Brief

“Quality Engineer at Cytiva. Skills: Quality Engineering, Validation, Regulatory compliance. Support/lead ME/PE to implement/maintain Process flow charts. Support/lead ME/PE to implement/maintain Process Control Plans”

Industry & Context.

Biotechnology
Problems you'll solve

Data analysis; Root cause analysis

What They're Looking For.

Must Have

Master's in scientific field, 3+ years experience, English (written & spoken), Dutch language proficiency, Analytical mind, Data analysis, ISO 9001 knowledge, ISO 13485 knowledge

Nice to Have

Root Cause analysis experience, QMS experience, Validation processes experience

What You'll Do.

Support/lead ME/PE to implement/maintain Process flow charts

Support/lead ME/PE to implement/maintain Process Control Plans

Support/lead ME/PE to implement/maintain Process FMEA

Support/lead ME/PE to implement/maintain validations

Issue validation documents

Review validation documents

Approve validation documents

Coordinate validation activities

Coordinate development of analysis methods

Support responses to customer questionnaires

Support responses to certification requests

Prepare standard responses for Customer Service

Maintain standard responses for Customer Service

Update standard responses for Customer Service

Act as Quality Lead in plant wide projects

Engage in R&D projects as quality lead

How You'll Work.

Team & Collaboration

Quality Department; R&D projects; Laboratory contractors

Communication Scope

Customer questionnaires; Certification requests

Full Job Description

**Be part of something altogether life-changing!** Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies. At Cytiva you will be able to continuously improve yourself and us – working on challenges that truly matter with people that care for each other, our customers, and their patients. With associates across 40+ countries, Cytiva is a place where every day is a learning opportunity – so you can grow your career and expand your skills in the long term. Forming part of the Biotechnology segment at Danaher, we bring together dedicated technical expertise and talent to develop the next generation of life-changing therapeutics. The _Quality Engineer_ for Cytiva is responsible _for_ maintaining the overview of the validated state of products, processes, methods and equipment. The employee will be handling deviations of any kind. The Quality Engineer is the Quality Lead in plant wide projects. The Quality Engineer will be closely engaged in R&D projects towards introduction of new products as quality lead. This position is part of the _Quality Department_ located in _Medemblik, the Netherlands_ and will be on-site. At Cytiva, our vision is, to advance future therapeutics from discovery to delivery. **In this role, you will have the opportunity to:** * _The Quality Engineer_ Support/lead ME/PE to implement/maintain, as a team member, Process flow charts, Process Control Plans, Process FMEA, validations. * The Quality engineer is responsible for issuing or reviewing and approving validation documents related to gamma irradiation and product sterility claims * Coordinate validation activities & development of analysis methods with laboratory contractors * _The Quality Engineer_ Support responses to customer questionnaires, certification requests and s

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