Associate Manager, Validation

Your New Role

We’re seeking an Associate Manager to lead a team of validation professionals from entry-level to specialist and expert, supporting a regulated biopharma manufacturing environment. Your focus will be on enabling the team to do their best work. This will include team building; personal development; aligning on priorities, allocating resources, and providing day-to-day guidance across various validation activities. You’ll translate standards and policy into clear, right-sized practices, ensuring timely, compliant execution that keeps production on-schedule and inspection-ready.

Main responsibilities

• Lead, coach, and develop a diverse validation team; delegate responsibilites, review deliverables, and provide technical mentorship.
• Plan and oversee validation lifecycle activities: commissioning and qualification (CQV), cleaning validation and ongoing periodic reviews.
• Own validation schedules aligned to site plans; ensure protocols/reports (URS, risk assessments, FAT/SAT, IQ/OQ/PQ) are delivered on time and to standard.
• Manage deviations, investigations, CAPAs, and change controls related to validated systems in partnership with QA, Engineering, MSAT, and Manufacturing.
• Standardize templates, tools, and risk-based approaches.
• Prepare the team and documentation for regulatory inspections; represent Validation in cross-functional forums.
• Track and report KPIs and drive continuous improvement.

Your impact

You will help make Validation a preferred stakeholder across the organization by ensuring timely completion of all deliverables by building robust structures to enable your team to excel. Through pragmatic, risk-based interpretation of standards, you’ll reduce rework and cycle times while strengthening compliance and inspection readiness. Your leadership will raise team capability, harmonize practices, and enhance cross-functional trust, resulting in predictable distribution of workload, smoother tech transfers, and confident inspection outcomes.

Skills & Knowledge we hope you possess

• Education: Bachelor’s or Master’s in engineering, life sciences, or a related field.
• Experience:
  • 6+ years in validation/CQV within GMP biopharma or pharma, including hands-on protocol/report authorship and execution.
  • 2+ years mentoring or leading others; direct people management experience preferred.
  • Background working in a changing, project-driven environment with tight schedules.
  • Exposure to regulatory inspections, investigations, and change management.
• Technical:
  • Strong grasp of validation lifecycle and risk-based approaches (e.g., ASTM E2500, GAMP 5, ICH Q8–Q10, EU Annex 15, 21 CFR Parts 11/210/211).
  • Experience with cleaning validation and PPQs.
  • Competence with quality systems (deviations, CAPA, CC), and document control; familiarity with CMMS/EMS/BMS/SCADA is a plus.
• Strengths:
  • Clear prioritization, stakeholder management, and concise technical communication.
  • Analytical, detail-oriented, and comfortable making judgment calls within policy.
  • Committed to safety, quality, and continuous improvement.

We hope you are

• A servant leader who develops people and sets clear expectations.
• Structured and data-driven, yet pragmatic in applying standards.
• Collaborative, with the ability to influence peers and partners to meet shared goals.
• Calm under pressure, with a bias for right-first-time and on-time delivery.

Your New Department & Team

You’ll join a collaborative Validation organization working closely with Engineering, MSAT, Manufacturing, and QA to enable compliant, efficient operations. The culture emphasizes accountability, psychological safety, and learning while balancing speed with rigor to support new products, improvements, and site expansion.

Questions

If you have questions, please contact our recruitment team. Please submit your CV and a brief cover letter. We review applications on a rolling basis and will close the posting once the right candidate is identified.

How to Apply

Submit your CV highlighting your equipment/process validation experience, deviation investigations, audit representation, and cross-functional leadership. We look forward to seeing how you’ll elevate our compliance and delivery excellence.

FUJIFILM Biotechnologys is a global leader in biologics contract development and manufacturing (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://fujifilmdiosynth.com/

FUJIFILM Biotechnologys Denmark (FDBD) 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 identity, 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 any form/method will be deemed the sole property of FUJIFILM, unless such firms were engaged by FUJIFILM for this requisition and a valid agreement is in place. In the event a candidate submitted outside of the FUJIFILM agency engagement process is hired, no fee will be paid.