Training Specialist (Pharmaceutical / cGMP)

The International Society for Pharmaceutical Engineering, Inc.; Greenfield (IN); On-site; USD 70,000 - 100,000; Full time

Job summary

The International Society for Pharmaceutical Engineering, Inc. is seeking a Training Specialist to lead advanced training design for a regulated laboratory and warehouse environment.

You will develop training matrices, curricula, and qualification programs, aligning with 21 CFR and GMP expectations. Collaboration with Quality, Operations, and client stakeholders will ensure audit readiness, records control, and competency evidence.

Qualifications

• College degree in life sciences or related field strongly preferred.
• 5+ years of progressive experience in training, learning and development, pharmaceutical quality, laboratory operations, clean room operations, regulated warehouse operations.
• Direct experience in pharmaceutical, biotech, laboratory testing, clean room, sampling, quality control or regulated distribution environments.
• Demonstrated experience with 21 CFR, cGMP/GDP, USP, data integrity, laboratory documentation, and audit readiness.
• Experience administering LMS/QMS platforms, assigning and configuring courses, developing curricula, maintaining training matrices, and reporting training status to leadership.
• Experience developing technical training materials, SOPs, job aids, checklists, assessments, and training guides.
• Experience conducting training needs assessments, gap analyses, OJT verification, competency assessments, remediation plans, and training effectiveness checks.
• Experience supporting deviations, corrective actions, change controls, audit responses, regulatory readiness, or continuous improvement projects
• Certifications in clean room gowning, laboratory safety, train-the-trainer, ASQ, GMP, data integrity, OSHA, HazMat, DOT/49 CFR are a plus.

Responsibilities

• Translate requirements into training matrices, curricula, qualification programs, job aids, assessments, and training effectiveness measures.
• Ensure training assignments, records, and competency evidence are accurate, current, controlled, and retrievable for audits.
• Collaborate with Quality, Operations, Laboratory, EHS, and client stakeholders to address 21 CFR and GMP requirements in training materials.
• Support audit readiness and regulatory inspections through robust training governance.

Skills

Advanced training program design

LMS/QMS administration

21 CFR/GDP/USP knowledge

Pharmaceutical & lab testing

Clean room behavior

USP/quality documentation

Excel / data analysis

Change management / escalation

Problem solving / critical thinking

Coaching & mentoring trainees

Education

College degree in life sciences or related field

5+ years progressive training & GxP experience

Tools

LMS platforms

QMS platforms

Job description

Job Title - Training Specialist

Location - Greenfield, IN (no relocation available and no VISA candidates or C2C/C2H or W2)

The Training Coordinator IV is an advanced-level, site-focused training role responsible for establishing, maintaining, and continuously improving the training program for a regulated warehouse operation that stores pharmaceutical products and performs sampling and testing activities in a clean room and/or laboratory environment This role is responsible for all applicable Training Coordinator III responsibilities, with increased emphasis on pharmaceutical cGMP/GDP expectations, laboratory controls, clean room behavior, contamination control, sample handling, data integrity, and competency-based qualification.

The Training Coordinator IV partners closely with Quality, Operations, Laboratory/Sampling personnel, EHS, site leadership, Corporate Quality, and client stakeholders to translate 21 CFR, USP, client, SOP, and site-specific requirements into effective training matrices, curricula, qualification programs, job aids, assessments, and training effectiveness measures. This role supports audit and regulatory inspection readiness by ensuring training assignments, records, and competency evidence are accurate, current, controlled, and readily retrievable.

Experience & Education -

• College degree in life sciences, microbiology, chemistry, pharmaceutical sciences, laboratory science, quality, education/training, or related field strongly preferred.
• 5+ years of progressive experience in training, learning and development, pharmaceutical quality, laboratory operations, clean room operations, regulated warehouse operations, or a related GxP environment preferred.
• Direct experience supporting or working in pharmaceutical, biotech, laboratory testing, clean room, sampling, quality control, quality assurance, or regulated distribution environments.
• Demonstrated experience with 21 CFR, cGMP/GDP, USP, data integrity, laboratory documentation, controlled documents, training records, audit readiness, or client/regulatory inspection.
• Experience administering LMS/QMS platforms, assigning and configuring courses, developing curricula, maintaining training matrices, monitoring completion, and reporting training status to leadership.
• Experience developing technical training materials, job aids, SOPs, work instructions, qualification checklists, assessments, resource guides, workshops, or role-based learning content
• Experience conducting training needs assessments, training gap analyses, OJT verification, competency assessments, training remediation plans, and training effectiveness checks.
• Experience supporting deviations, corrective actions, change controls, audit responses, client requests, regulatory readiness, or continuous improvement projects.
• Clean room gowning qualification, laboratory safety, train-the-trainer, ASQ, GMP, data integrity, OSHA, HazMat, DOT/49 CFR, PIT trainer, or similar certifications preferred.

Critical Skills

• Advanced knowledge of training program design, facilitation, onboarding, adult learning, competency-based qualification, LMS/QMS administration, training reporting, and training effectiveness evaluation.
• Strong working knowledge of pharmaceutical cGMP/GDP expectations, 21 CFR requirements, USP concepts, data integrity principles, controlled documentation, quality records, laboratory documentation, and audit-readiness practices.
• Pharmaceutical and laboratory testing background with the ability to understand and translate sampling, clean room, laboratory, and testing requirements into practical training and qualification programs.
• Knowledge of clean room behavior, gowning practices, contamination control, sample handling, chain of custody, laboratory testing support, laboratory equipment use, Good Documentation Practices, and ALCOA+ data integrity expectations.
• Ability to support training related to applicable 21 CFR expectations, including cGMP, electronic records/electronic signatures, drug storage/distribution, documentation controls, laboratory controls, and regulated quality system processes.
• Ability to interpret and incorporate applicable USP chapters, client requirements, SOPs, specifications, test methods, sampling procedures, and quality requirements into training materials and competency assessments.
• Strong technical writing capability for SOPs, work instructions, job aids, checklists, training guides, qualification records, assessments, audit tools, and resource materials.
• Advanced Excel, Microsoft Office, reporting, data analysis, dashboard development, and training metric tracking skills.
• Ability to lead stakeholders through change, communicate effectively with all levels of the organization, influence without direct authority, and **escalate** compliance risks appropriately.
• Strong problem-solving, critical thinking, prioritization, follow-up, decision-making, project management, and continuous improvement skills.
• Ability to coach, mentor, and support Training Coordinators, designated trainers, SMEs, site training contacts, supervisors, and employees working in regulated areas.