Job Title

Technical Training Lead

Requisition

JR000015996 Technical Training Lead (Open)

Location

College Park, Dublin

Additional Locations

Job Description Summary

The Technical Training Lead is responsible for the design, coordination, and delivery of training programs to support pharmaceutical manufacturing operations, with particular focus on manufacturing operations, ramp-up activities, and ongoing compliance with GMP and regulatory requirements.
The role ensures that personnel are trained, qualified, and competent to safely and effectively perform their roles in support of manufacturing operations, capital projects, and continuous improvement initiatives.
The Technical Training Lad will work cross-functionally with Manufacturing, Quality, Engineering, EHS, and Project Teams to enable timely and compliant training delivery, particularly during periods of increased operational demand, new equipment introduction, or process changes.

Job Description

Roles and Responsibilities

1.     Operational Support

·       Act as a qualified and competent manufacturing resource during start-up and ramp-up phases, performing manufacturing activities in accordance with approved procedures until sufficient personnel are trained and deemed competent.

·       Support manufacturing operations as required to maintain continuity of operations during periods of training, onboarding, or increased operational demand.

·       Gradually transition from direct manufacturing activities as training coverage is established and operational competency is embedded across the team.

·       Provide hands-on operational support by partnering closely with operations, quality, engineering, TechOps and other stakeholders to ensure training initiatives align with shop-floor realities and operational priorities.

·       The role supports daily manufacturing activities by identifying skill gaps, coordinating training interventions, and facilitating effective knowledge transfer to operators, leads, and support staff, ensuring safe, efficient, and compliant execution of manufacturing processes.

 

2.     Training Program Development and Delivery

·       Design, plan, and deliver comprehensive training programs  for the manufacturing processes, equipment, systems, and behaviors, using a blended approach that includes classroom instruction, hands-on demonstrations, and on-floor coaching.

·       Working collaboratively with all functions, the Lead will ensure training content is practical, role-specific, and aligned with operational needs, while effectively engaging learners at different experience levels.

·       Apply practical and hands-on training approaches to ensure effective knowledge transfer and competency development

·       Support the creation, development, and maintenance of onboarding and role-based training curricula and materials, aligned with role requirements and site training matrices, to ensure effective and consistent readiness of new and existing team members.

 

3.     Manufacturing Readiness and Ramp-Up Support

·       Play a critical role in manufacturing readiness and ramp-up activities for new processes, products, equipment, or facilities, including start-up and scale-up phases. Develop and execute readiness plans, coordinate pre-launch and ramp-up training, support process validation readiness, and ensure manufacturing teams are trained, confident, and capable of meeting production, safety, quality, and performance targets.

·       Ensure training plans and execution are aligned with production schedules, ramp-up strategies, and project milestones.

·       Partner cross-functionally with Manufacturing, Engineering, Quality, and Project teams to define and support training requirements for new or modified processes, equipment, systems, and facilities.

·       Proactively identify, assess, and address training gaps or risks that could impact operational performance, compliance, or ramp-up timelines.

 

4.     Content Development and Documentation

·       Collaborate with Subject Matter Experts (SMEs) to develop and maintain training materials, including SOPs, work instructions, presentations, assessments, and practical evaluations

·       Ensure training materials are accurate, current, and aligned with approved procedures and quality systems

·       Support preparation of technical documentation, including validation protocols, risk assessments, and project reports, as required

5.     Compliance, Quality, and Training Administration

·       Ensure all training activities comply with GMP, regulatory requirements, and internal quality systems

·       Maintain accurate and up-to-date training records, qualifications, and training matrices within the site Learning Management System (LMS)

·       Assess training effectiveness and individual competency through evaluations, observations, and feedback

·       Participate in internal audits, regulatory inspections, and quality reviews related to training and competency management

6.     Continuous Improvement and Change Management

·       Support change management initiatives by assessing training impacts associated with process, equipment, or system changes

·       Identify opportunities to improve training processes, delivery methods, and operational effectiveness

·       Drive continuous improvement initiatives based on operational feedback, deviations, audit findings, and performance metric

·       Develop reporting mechanisms and dashboards to track manufacturing and training readiness, risks, timeline progress, and training effectiveness, leveraging data and stakeholder feedback to continuously improve outcomes

 

 

Experience, Qualifications and Education Requirements

·       Bachelor’s degree in science, Engineering, Education, or a related discipline (or equivalent experience) - Desired

·       Experience working in a regulated pharmaceutical, biotech, or medical device manufacturing environment – Essential

·       Proven experience delivering training in a GMP environment (manufacturing, quality, or technical training preferred)

·       Working knowledge of GMP, regulatory expectations, and training compliance requirements

·       Experience supporting manufacturing start-ups, ramp-ups, or major change initiatives is highly desirable

·       Familiarity with Learning Management Systems (LMS) and electronic training records

·       Train-the-Trainer certification or equivalent experience is an advantage

·       Excellent technical writing and documentation skills, including preparation of validation protocols, risk assessments, and project reports.

Competencies / Preferred Skills

• Facilitation and presentation skills: Strong ability to engage and influence diverse audiences.
• Communication and interpersonal skills: Excellent verbal and written communication, with proven ability to collaborate effectively across cross-functional teams.
• Training methodology expertise: Solid understanding of effective, competency-based workplace training methodologies.
• Organisation and time management: Strong ability to manage multiple priorities and deadlines in a dynamic environment.
• Attention to detail and compliance focus: High level of accuracy with a strong emphasis on GMP compliance and documentation standards.
• Technical translation capability: Ability to translate complex technical, operational, or regulatory requirements into clear, practical, and role-relevant training.
• Operational agility: Comfortable operating in fast-paced, project-driven manufacturing environments.
• Problem-solving and continuous improvement: Demonstrated capability to identify issues and drive process optimization and operational improvements.
• Digital and systems proficiency: Proficient in Microsoft Office applications and digital training platforms, including Learning Management Systems.
• Adaptability and initiative: Proactive and self-directed, with the ability to anticipate challenges and drive effective solutions independently
• Collaboration and knowledge sharing: Strong team-oriented approach, with the ability to share best practices, support knowledge transfer, and provide mentorship

At Keenova, we believe that no one should be alone in their pursuit of better health. This purpose drives us as we pair quality therapeutics with human support—showing up in big moments and small to help patients find comfort and confidence.

 

We bring deep expertise and resolve to every therapeutic area we serve, including immunology, urology, men’s health, orthopedics, critical care, and pediatric endocrinology. We work with patients, care partners, and physicians to help them navigate healthcare system complexity and access therapies that make a meaningful difference.

 

We are Keenova—keen to solve, keen to serve. Learn more at www.keenova.com.