Copenhagen, Capital Region of Denmark, Denmark · On-site
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…
Skills: GMP, Training Delivery, Onboarding, LMS, Technical Writing
Town of Lynn, Wisconsin, United States · Remote OK
$164k–$267k/yr
Join Us in Bringing Hope to Life Our purpose is to bring hope to life by enabling life‑changing therapies for patients around the globe, creating a healthier and happier tomorrow. To advance this purpose, we rely on team…
Skills: Business Development, Strategic Planning, Relationship Building, Sales Territory Management, Contract Negotiation
Copenhagen, Capital Region of Denmark, Denmark · On-site
Help strengthen commercial downstream processes for complex biologics At AGC Biologics, you will help support the manufacturing of commercial biotechnological products where operational efficiency, regulatory compliance,…
Skills: Downstream processing, Chromatography, Bioprocessing, GMP, Technical documentation
Bothell, Washington, United States · On-site
$94k–$129k/yr
Join Us in Bringing Hope to Life Our purpose is to bring hope to life by enabling life‑changing therapies for patients around the globe, creating a healthier and happier tomorrow. To advance this purpose, we rely on team…
Skills: Project management, Biologics development, GMP manufacturing, Technology transfer, Cross-functional leadership
Bothell, Washington, United States · On-site
$21/hr–$27/hr
Join Us in Bringing Hope to Life Our purpose is to bring hope to life by enabling life‑changing therapies for patients around the globe, creating a healthier and happier tomorrow. To advance this purpose, we rely on team…
Skills: Media preparation, Buffer preparation, GMP compliance, Documentation accuracy, Logbook management
Copenhagen, Capital Region of Denmark, Denmark · On-site
Do you want to be part of a company helping customers bring new advanced biological products to market? Are you passionate about providing innovative solutions to complex challenges? Then join a dynamic and international…
Skills: Microbial Upstream Manufacturing, cGMP, API Production, Fermentation, Harvesting
Copenhagen, Capital Region of Denmark, Denmark · On-site
Working hours: The current working hours are 06:00–17:00. 08:00–19:00 shift may be introduced in the future, depending on business needs and employee preferences. Help bring life-changing therapies to patients worldwide …
Skills: Buffer Preparation, GMP Compliance, Manufacturing Operations, Documentation, Equipment Sterilization
Copenhagen, Capital Region of Denmark, Denmark · On-site
About the job Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe. Our mission is to work side by side with our customers to improve patients’ lives by bringing new biop…
Skills: Maintenance Engineering, Reliability Engineering, FMECA, Risk Assessment, Life Cycle Asset Management
Bothell, Washington, United States · On-site
$67k–$92k/yr
Join Us in Bringing Hope to Life Our purpose is to bring hope to life by enabling life‑changing therapies for patients around the globe, creating a healthier and happier tomorrow. To advance this purpose, we rely on team…
Skills: CMMS Administration, Maintenance Planning, Asset Management, Data Governance, Reporting
Copenhagen, Capital Region of Denmark, Denmark · On-site
As a CDMO, AGC Biologics manufactures drugs for a variety of different customers. Depending on the customer needs, this can be for drugs ranging from development to clinical and commercial production. Right now, you have…
Skills: Downstream processing, cGMP, Manufacturing support, Root cause investigation, Batch documentation
Copenhagen, Capital Region of Denmark, Denmark · On-site
Do you want to help customers bring life-saving biological products to market? Do you thrive in a role where you can learn and grow? Do you value teamwork and love being part of a cross-functional team? If so, this posit…
Skills: Downstream process development, Mammalian cell lines, Microbial cell lines, Process characterization, Robustness studies
Copenhagen, Capital Region of Denmark, Denmark · On-site
AGC Biologics is a contract manufacturing organization within the biotech industry. We work with the development of biopharmaceutical production processes as well as GMP manufacturing of biopharmaceutical proteins for bo…
Skills: Laboratory techniques, Buffer preparation, GDocP, Documentation, Data entry
Copenhagen, Capital Region of Denmark, Denmark · On-site
As a Production Cleaning Lead, you'll play a key role in ensuring our GMP manufacturing facilities remain clean, compliant and ready to support the production of medicines for patients around the world. Acting as the lin…
Skills: GMP Compliance, Facility Management, Vendor Management, Cleaning Operations, Stakeholder Management
Copenhagen, Capital Region of Denmark, Denmark · On-site
At AGC Biologics, we are committed to a high standard of quality and execution - because we recognize that meeting the needs of our customers contributes to meeting the needs of providers and patients. As a global CDMO, …
Skills: Regulatory inspections, Internal auditing, Customer audits, Inspection readiness, cGMP
Copenhagen, Capital Region of Denmark, Denmark · On-site
Would you like to help secure the quality of our production facilities in Copenhagen, where the purpose is to bring hope to life by enabling life-changing therapies for patients around the globe? As our next Manager, Fac…
Skills: People Leadership, GMP Compliance, Facility Qualification, Cleanroom Management, Clean Utilities Management
Copenhagen, Capital Region of Denmark, Denmark · On-site
Are you an experienced leader with a passion for compliance, operational excellence, and digital transformation? As our new Compliance & Support Manager in Supply Chain Management (SCM) you will get the chance to lead an…
Skills: Compliance Management, Supply Chain Management, People Leadership, GxP Compliance, Warehouse Management Systems
Copenhagen, Capital Region of Denmark, Denmark · On-site
Every improvement you make to an automation platform has the potential to help life-changing therapies reach patients around the world. At AGC Biologics, automation is much more than technology, it is a key enabler of sa…
Skills: People Leadership, Digital Transformation, GMP Compliance, GAMP 5, EU Annex 11
Heidelberg, Baden-Württemberg, Germany · On-site
$60k–$80k/yr
Über AGC Biologics AGC Biologics ist eines der weltweit führenden Unternehmen im Bereich der biopharmazeutischen Auftragsentwicklung und -produktion (CDMO). Unser globales Netzwerk umfasst Standorte in den USA, Europa un…
Skills: OT Security Architecture, IEC 62443, Purdue Model, Network Segmentation, PAM (Privileged Access Management)
Bresso, Lombardy, Italy · On-site
$34k–$38k/yr
Attività principali: Gestione deviazioni relative agli aspetti di processo produttivo e metodi analitici;Eseguire le attività di batch record review;Redigere product specification file/similari;Partecipare attivamente al…
Skills: Deviation Management, Batch Record Review, Product Specification Filing, Regulatory Inspections, Lot Release Documentation
Heidelberg, Baden-Württemberg, Germany · On-site
AGC Biologics sucht ab sofort unbefristete Unterstützung für das Produktionsteam am Standort Heidelberg: Ihre Aufgaben: Arbeiten in Reinräumen der Klassen C und BChromatographische Aufreinigung von Proteinen und pDNAAbfü…
Skills: Chromatographic Purification, Aseptic Processing, Cleanroom Operations, In-process Controls, GMP Documentation
Sign up with Clera and we'll reach out the moment a role actually fits you — no more spraying applications into the void.
The GMP Training Specialist will lead classroom training, manage onboarding programs, and ensure all training documentation and LMS records are compliant with GMP standards. They will also collaborate with cross-functional teams to create technical training materials and optimize training workflows using LEAN methodologies.
Candidates should have 3-5 years of experience in a GMP manufacturing or training-related role with a strong understanding of biopharmaceutical processes. Proficiency in adult learning principles, GDocP, and digital learning tools like Articulate 360 is required.
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.
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.
We work side by side with our customers to improve patients’ lives by bringing new biopharmaceutical products to market.
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 to provide friendly and expert services. We provide world-class development and manufacturing of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cell therapies. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba and Yokohama, Japan. Visit www.agcbio.com to learn more.
Offices: 22021 20th Avenue SE, Bothell, WA 98021, US · VANDTAARNSVEJ 83B, DK-2860 SOEBORG, Copenhagen CVR: 25950941, DK · CZERNYRING 22, Heidelberg, Heidelberg 69115, DE · 10, GOIKAIGAN, Chiba, ICHIHARA CITY 290-8566, JP · 4000 Nelson Rd, Longmont, Colorado 80503, US
We work side by side with our customers to improve patients’ lives by bringing new biopharmaceutical products to market.
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 to provide friendly and expert services. We provide world-class development and manufacturing of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cell therapies. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba and Yokohama, Japan. Visit www.agcbio.com to learn more.
Offices: 22021 20th Avenue SE, Bothell, WA 98021, US · VANDTAARNSVEJ 83B, DK-2860 SOEBORG, Copenhagen CVR: 25950941, DK · CZERNYRING 22, Heidelberg, Heidelberg 69115, DE · 10, GOIKAIGAN, Chiba, ICHIHARA CITY 290-8566, JP · 4000 Nelson Rd, Longmont, Colorado 80503, US
