Validation Training Specialist

Location: Clayton

Job Title:

Validation Training Specialist

Job Description

The Validation Training Specialist designs, delivers, and maintains Good Manufacturing Practice (GMP) training programs that support a fully validated manufacturing facility, including an automated warehouse and production lines. This role focuses on developing structured classroom and hands-on sandbox coaching sessions for various systems, ensuring training content is compliant, engaging, and aligned with established quality and validation standards. The specialist collaborates closely with cross-functional teams to build effective training programs for key stakeholders and plays a visible role on a large greenfield project.

Responsibilities

+ Develop and deliver GMP-focused training classes that support the proprietary approach to validating the entire facility, including automated warehouse and manufacturing lines.

+ Design and facilitate coaching and sandbox training sessions for different systems used in warehouse automation and on manufacturing lines.

+ Ensure all training-related documentation is accurately recorded and maintained in the Quality Management System (QMS), including ISOtrain records and proper filing of materials.

+ Establish, implement, and drive the use of training tracking and escalation processes to ensure timely completion and follow-up of required training.

+ Create, maintain, and continuously improve training materials and job training plans (JTPs), ensuring they are current, effective, and aligned with GMP and validation requirements.

+ Produce multimedia training content, such as audio, video, and simulator-based materials, and collaborate with instructional designers as needed to enhance learning effectiveness.

+ Participate in the creation, editing, coaching, and implementation of training program content and materials in line with established training processes.

+ Serve as a subject matter expert in the application of established training processes and lead or participate in local and global training development workshops.

+ Conduct and/or coordinate training sessions for assigned areas, including classroom and on-the-job training, and ensure the effectiveness of shop floor trainers.

+ Communicate and coordinate training activities and requirements with key stakeholders, including Quality Assurance, shift leadership teams, and training workshop members.

+ Support validation- and systems-related training, ensuring that learners understand how to apply validation principles and use relevant systems correctly.

+ Contribute to building out new training programs for key stakeholders and maintain strong relationships with site leadership to align training with business needs.

Essential Skills

+ Proven experience working in a GMP-regulated environment, such as pharmaceutical or other life sciences manufacturing.

+ Demonstrated experience delivering training in a classroom setting, with a focus on teaching adults GMP-related content.

+ Hands-on experience with validation activities and/or IT or systems-related work in a regulated environment.

+ Familiarity with enterprise and quality systems such as SAP, Veeva, Smartsheet, SRV, and TIMS, or similar platforms used in GMP operations.

+ Ability to create, manage, and document training records within a Quality Management System (QMS), including the use of ISOtrain or comparable training management tools.

+ Strong skills in designing and using training materials, including job training plans (JTPs), to support effective learning and competency development.

+ Capability to develop multimedia training content, including audio, video, and simulator-based materials, to enhance learner engagement and retention.

+ Strong communication and collaboration skills to coordinate effectively with Quality Assurance, operations, and other stakeholder groups.

+ Comfort and confidence presenting in front of groups and facilitating discussions in a classroom or workshop environment.

Additional

Skills & Qualifications

+ Experience supporting validation training programs or initiatives in a large-scale or greenfield project environment.

+ Working knowledge of SAP for manufacturing or warehouse operations.

+ Exposure to or experience with Pas-X or similar Manufacturing Execution Systems (MES).

+ Experience working with Veeva, Smartsheet, SRV, and TIMS or comparable systems used in GMP and validation contexts.

+ Experience in developing or refining training processes, including tracking, escalation, and effectiveness measurement.

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