Competencies of Automation Compliance Specialist
By John Kehoe, Technical & OEE Partners
Regulatory Compliance Specialist
21 CFR Part 11 | GAMP5 | EU GMP Annex 1 | Computer Systems Validation
Senior Regulatory Compliance Specialists should have extensive experience supporting pharmaceutical and biotech manufacturing operations within EU and FDA-regulated environments. They should be a recognised subject matter expert in computerised systems compliance, data integrity, and validation of automated manufacturing and packaging systems. Proven ability to translate regulatory requirements into practical, inspection-ready engineering and automation solutions.
Core Competencies
- 21 CFR Part 11 & EU GMP Annex 11 Compliance
- GAMP5 Risk-Based Validation Lifecycle
- EU GMP Annex 1 (Sterile Manufacturing & CCS considerations)
- Computer Systems Validation (CSV)
- Data Integrity (ALCOA+)
- Automation & Packaging Equipment Validation
- Regulatory Inspection Readiness & Audit Support
Professional Experience & Expertise
- 10–20+ years' experience in regulated pharmaceutical manufacturing, including sterile and non-sterile operations.
- Extensive hands-on involvement in automation and packaging system validation, covering PLC, HMI, SCADA, vision systems, and serialisation solutions.
- Acts as independent SME supporting pharmaceutical manufacturers, OEM machine suppliers, and system integrators across Ireland and Europe.
- Regularly engaged during project lifecycle phases including URS development, vendor assessment, FAT/SAT execution, and site commissioning.
Validation & Documentation
- Author and reviewer of regulated documentation, including:
- Validation Master Plans (VMP)
- User Requirement Specifications (URS)
- Functional, Hardware, and Software Design Specifications (FS/HDS/SDS)
- GAMP Category and Risk Assessments
- Data Integrity and Cybersecurity Risk Assessments
- IQ, OQ, and PQ protocols and reports
- Expert in defining and assessing:
- Audit trail functionality
- Role-based access control
- Electronic signatures
- Time synchronisation and record retention strategies
Regulatory Inspection Support
- Direct experience supporting inspections
- Performs compliance gap assessments and remediation planning.
- Acts as technical SME during inspections and regulatory audits.
- Strong capability in aligning engineering design decisions with regulatory expectations.
Industry & Commercial Experience
- Experienced in reviewing and de-risking OEM and system integrator proposals.
- Identifies regulatory and commercial risks related to:
- Scope ambiguity
- Validation responsibility splits
- Data integrity and system ownership
- Trusted advisor to project teams for compliance-driven decision-making.
John Kehoe
Founder & Principal – Board-Level Technical Advisor
John Kehoe advises Boards and Executive Teams on GMP automation, regulatory compliance, and digital manufacturing risk. He is a recognised subject matter expert.