Senior Training Specialist
About The Position
The Senior Training Specialist is responsible for designing, delivering, and maintaining robust training programs that ensure personnel within the CDMO facility are fully qualified to perform their roles in compliance with regulatory, quality, and safety standards. This role supports cross-functional teams—including Manufacturing, Quality, QC, Engineering, Supply Chain, and MSAT—by coordinating onboarding, technical skills development, and ongoing training initiatives aligned with cGMP requirements. The successful candidate will collaborate with subject matter experts to develop learning solutions; develop and maintain training tools (curricula, OJTs, SOPs, e-learning); deliver training; assure site compliance with Quality Standards; roll-out site training initiatives; and achieve compliance and business results through strong partnerships with other site functions.
Requirements
- Bachelor’s degree in Life Sciences, Education, Organizational Development, or related field (or equivalent experience).
- Must have experience working in a highly regulated manufacturing environment.
- Knowledge of cGMP, GxP, and regulatory expectations for training and documentation.
- Experience with electronic Learning Management Systems (LMS/TMS).
- Strong communication, facilitation, and interpersonal skills.
- Ability to collaborate with SMEs across technical functions.
- Demonstrated experience supporting regulatory inspections.
- Familiarity with risk‑based training approaches and quality systems.
- Strong working knowledge of Adult Learning Principles.
Nice To Haves
- 3+ years of experience in a pharmaceutical, biotech, or CDMO environment preferred.
- Experience designing technical training for aseptic processing, biologics manufacturing, packaging and inspection, or sterile fill–finish operations preferred.
- Certification in training, instructional design, or adult learning (e.g., ATD, CPTM) preferred.
Responsibilities
- Develop, implement, and continuously improve training curricula for manufacturing operations, quality systems, and other GxP‑regulated functions.
- Deliver instructor‑led training (ILC) sessions, hands‑on training, and blended learning modules.
- Collaborate with subject matter experts (SMEs) to create clear, accurate SOP-based training materials.
- Ensure training aligns with EU Annex 1, FDA, EMA, ICH, and other applicable regulatory expectations.
- Ensure training content and execution meet internal and external audit expectations.
- Support regulatory inspections by providing training documentation and acting as the training SME.
- Identify gaps in training programs and lead corrective and preventive action (CAPA) activities.
- Manage onboarding programs for new hires in GxP and non‑GxP functions.
- Coordinate cross‑training initiatives to support operational flexibility.
- Facilitate competency assessments and qualification programs for critical job tasks.
- Analyze training effectiveness using feedback, performance data, and error/trend reports.
- Recommend and implement improvements to training delivery, materials, and workflows.
- Champion adult learning principles and modern training methodologies within the organization.
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What This Job Offers
Career Level
Senior
