Pharma Training Architect: cGMP & Compliance Lead

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

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.