GMP Training Specialist

Reposted Yesterday
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Hiring Remotely in Copenhagen, Capital, DNK
Remote
Mid level
Biotech
The Role
Deliver and design GMP training, onboarding, and eLearning for Manufacturing & Engineering. Maintain compliant LMS records and training documentation, run classroom and practical sessions (aseptic behavior, gowning, train‑the‑trainer), apply TWI/LEAN for continuous improvement, and collaborate with SMEs to assess training needs and competency.
Summary Generated by Built In

BRINGING HOPE TO LIFE
Join our Manufacturing & Engineering Training Team, where high standards and strong teamwork ensure our employees are trained, inspection-ready, and committed to protecting the safety and quality of our products.

Are you passionate about elevating GMP training standards, shaping onboarding experiences, and guiding Manufacturing & Engineering employees toward excellence in a GMP environment? Do you excel at leading classroom training while also enjoying the strategic and documentation work required in a GMP environment? If so, you might be the GMP Training Specialist we’re looking for.

What will you do?

As our new GMP Training Specialist, you will play a central role in empowering our Manufacturing & Engineering teams through impactful training delivery, structured onboarding, and continuous improvement of our training systems & materials.

  • Provide first class service support to all employees regarding training systems, documentation, and onboarding activities while collaborating with the CPH Training Community.

  • Ensure all training documentation and LMS records are precise, current, and fully compliant with GMP standards, ready for any audit & inspections.

  • Facilitate onboarding programs for newcomers, ensuring a smooth, engaging, and compliant introduction to our Manufacturing & Engineering processes.

  • Create and revise GMP technical training material, eLearnings, job aids, and other training content.

  • Collaborate closely with Managers, Supervisors, SMEs, and training colleagues to identify GMP training needs, streamline processes, and strengthen competency frameworks.

  • Deliver dynamic classroom and practical training sessions, including GMP fundamentals, Aseptic Behavior, Gowning, and Train-the-Trainer programs.

  • Apply TWI methodology to support consistent standards, improved skills, and effective on-the-job training.

What do you need to succeed?

  • Relevant experience or education within GMP manufacturing, ideally 3–5 years in a technician, scientist, or GMP training-related role.

  • Strong understanding of biopharmaceutical GMP processes and GMP training requirements.

  • Exceptional organizational skills and a keen eye for detail, ensuring documentation consistently complies with Good Documentation Practices (GDocP) and ALCOA+ principles.

  • Demonstrated understanding of adult learning principles and the ability to apply them effectively in training design and delivery.

  • Knowledge of TWI (Training Within Industry) and LEAN methodology, or a strong willingness to learn and apply them.

  • Comfortable with applying LEAN practices to optimize training workflows and enhance the effectiveness of our learning solutions.

  • Solid communication skills in English; Danish is a bonus but not required.

  • Comfort using Office 365 (Super User) and digital learning tools such as Articulate 360.

Who are you as a person?

  • You are drive change, self driven, proactive, structured, and service-minded, bringing energy, curiosity, and a good sense of humour to create a positive team atmosphere.

  • You thrive in a fast-paced environment and maintain high-quality standards.

  • You appreciate a workplace where diversity and teamwork are part of everyday life.

  • You identify with our core values: TRUST, INGENUITY, QUALITY, KNOWLEDGE, TEAMWORK & ACCOUNTABILITY.
    You may not meet every single requirement, and that’s okay. If this sounds like your kind of challenge, we look forward to hearing from you.

Ready to join us?

Please submit your application no later than 31 August 2026.
 

Please note that we only accept applications submitted through our online recruitment system. Applications sent by email cannot be considered.
 

We review applications on an ongoing basis and look forward to receiving your application.
 

To support an inclusive recruitment process and ensure an unbiased assessment of all candidates, please do not include a photo in your application.
 

Please note that we are only able to consider candidates who are already based in Denmark or Greater Malmø Area, as relocation support is not available for this position.

Who We Are 
AGC Biologics is a global Contract Development and Manufacturing Organization with a strong presence in Denmark. From our Søborg site, we develop and manufacture life‑changing advanced biologics for some of the world’s most innovative pharmaceutical companies. Together with our team members across Europe, the U.S., and Japan, we deliver development and manufacturing of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells therapies. Across our global network, we are united by one mission: To work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.  

Skills Required

  • 3-5 years relevant experience or education in GMP manufacturing, technician, scientist, or training-related role.
  • Strong understanding of biopharmaceutical GMP processes and GMP training requirements.
  • Experience maintaining training documentation and LMS records in compliance with Good Documentation Practices (GDocP) and ALCOA+.
  • Designing and delivering classroom and practical GMP training, including GMP fundamentals, aseptic behavior, gowning, and Train‑the‑Trainer.
  • Demonstrated understanding and application of adult learning principles in training design and delivery.
  • Comfortable using Office 365 at an advanced (Super User) level and digital learning tools such as Articulate 360; eLearning development experience and LMS proficiency.
  • Knowledge of TWI (Training Within Industry) and LEAN methodology, or strong willingness to learn and apply them.
  • Exceptional organizational skills, attention to detail, and commitment to quality.
  • Solid communication skills in English (Danish is a bonus).
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The Company
HQ: Bothell, WA
2,241 Employees

What We Do

AGC Biologics offers deep industry expertise and uniquely customized services for the scale-up and cGMP manufacture of protein-based therapeutics (using mammalian and microbial systems), mRNA, pDNA, viral vector and cell therapy products, from pre-clinical to commercial production, including our proprietary CHEF1TM Expression System for efficient protein production with CHO cells. Our company DNA drives us to provide innovative solutions to partner with our customers in helping them reach their goals and accelerate their projects at our cGMP-compliant facilities in the US, Europe and Japan, as well as to facilitate approval and manage spending during the product lifecycle. We forge exceptionally strong partnerships with our customers and we never lose sight of our commitment to deliver reliable and compliant drug substance. Visit www.agcbio.com to learn more.

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