QA Validation Professional for Drug Substance

Are you ready to play a key role in a newly established QA Validation Team?

Do you excel in quality assurance and thrive in challenging environments?

Then we hope that you will be our new colleague!

Your New Role

As a QA Validation Professional in our Drug Substance (DS) QA Validation Team, you will help ensure compliance and quality excellence. Your primary tasks will include:

• Review and approve validation documentation, including IQ, OQ, PQ & PV protocols for equipment, instruments and utilities
• Provide quality oversight for validation processes
• Represent QA during risk assessments
• Ensure systems, equipment, and processes comply with FDA, EU, and site-specific requirements
• Collaborate as a key QA contact for the Validation Department
• Review and approve change controls, deviations and SOP updates
• Participate in audits and inspections, serving as a subject matter expert
• Train and align colleagues within the QA framework
• Drive continuous improvement initiatives within the team and with stakeholders

Skills & Knowledge

We’re keen to meet someone with:

• A university degree in life sciences or a related field
• Experience in quality assurance and validation
• Understanding of Good Documentation Practices, GMP, Quality Systems, and pharmaceutical legislation
• Strong collaborative and communication skills
• Attention to detail and commitment to excellence

We appreciate unique talents, so even if you don’t tick every box above, we’d love to read your application!

We Hope You are

A detail-oriented team player thriving in a changing environment who sees the bigger picture and is eager to help shape the direction of the team and our collaboration within the new team.

Your New Team & Department

Our department is experiencing growth and currently consists of approximately 50 people. We put teams over hierarchy by structuring the department into Upstream-, Downstream- and Validation-teams where daily interactions and support foster professional and personal development across the Teams.

We encourage you to bring your full self to work every day, as we value everyone’s unique talents and strengths. So just be you!

Our international and informal environment maintains a high pace and focus on life balance while fostering fun and engagement.

Application

Has this sparked your interest? Then please upload your CV and cover letter as soon as possible.

FUJIFILM Biotechnologies is a global leader in biologics contract development and manufacturing Organization (CDMO), partnering with innovative biotech and biopharma companies to transform healthcare. With locations in Denmark, the UK, and the USA, we support every stage of our customers’ product lifecycle, from breakthrough cures to life-saving vaccines.

Our success starts with our people—their passion drives progress, innovation, and impact. Join a diverse, inclusive workplace that values collaboration, fosters growth, and empowers future generations. Together, we’re enriching communities, protecting the environment, and reimagining healthcare’s potential.

Shape the future with us—your drive meets boundless opportunity here https://fujifilmbiotechnologies.fujifilm.com/

FUJIFILM Biotechnologies Denmark is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, sexual orientation, gender identify or any other protected class.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.