GMP Training Specialist

agcbio; København; On-site; DKK 520,000 - 760,000; Full time

Job summary

AGC Biologics Denmark is seeking a GMP Training Specialist to elevate our training delivery, onboarding, and documentation within a fast-paced GMP environment. You will lead classroom and practical training, develop GMP materials, and collaborate with cross‑functional teams to strengthen competency frameworks.

The role emphasizes continuous improvement of training systems using LEAN and TWI, with strong emphasis on accuracy, ALCOA+ and Good Documentation Practices.

Qualifications

• GMP manufacturing experience or education.

Responsibilities

• Provide first class service support to 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 audits and inspections.
• Facilitate onboarding programs for newcomers, ensuring a smooth, engaging introduction to Manufacturing & Engineering processes.
• Create and revise GMP training material, eLearnings, job aids, and other training content.
• Collaborate with Managers, Supervisors, SMEs, and training colleagues to identify GMP training needs and streamline processes.
• 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 and improved on‑the‑job training.

Skills

GMP training delivery

Adult learning principles

LEAN methodology

TWI (Training Within Industry)

Office 365 (Super User)

Articulate 360

English communication

Danish (bonus)

Tools

Articulate 360

LMS systems

Job description

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.

We only consider candidates who are already based in Denmark or Greater Malmø Area, as relocation support is not available for this position.

Application deadline: 31 August 2026.

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.