GMP Training Specialist

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients lives by bringing new biopharmaceuticals to market.

GMP Training Specialist

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 were 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 35 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 and digital learning tools such as Articulate 360.

Who are you as a person

• You are 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 thats okay. If this sounds like your kind of challenge we look forward to hearing from you.

Our culture at AGC Biologics is defined by the six core values: Knowledge Trust Quality Ingenuity Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe.

AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins plasmid DNA (pDNA) messenger RNA (mRNA) viral vectors and genetically engineered cells. Our global network spans the U.S. Europe and Asia with cGMP-compliant facilities in Seattle Washington; Boulder and Longmont Colorado; Copenhagen Denmark; Heidelberg Germany; Milan Italy; and Chiba Japan. We currently employ more than 2500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients most complex challenges including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more visit.Want to keep posted about our growth and learn more about our company Follow us on LinkedIn and give us a quick Like on Facebook!

AGC Biologics offers a highly competitive compensation package and a friendly collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age ancestry color family or medical care leave gender identity or expression genetic information marital status medical condition national origin physical or mental disability political affiliation protected veteran status race religion sexual orientation or any other characteristic protected by applicable laws regulations and ordinances.