cGMP Validation Engineer IV Expert

YOGESH SRAVAN

Groton, CT 401-***-**** ******.*****@*****.***

PROFESSIONAL SUMMARY

Senior QA Validation Specialist with 7+ years of cGMP pharmaceutical validation experience, applying as Validation Engineer IV at PCI Pharma Services' Bedford facility. Strengths in equipment, facility, and process validation: DQ/IQ/OQ/PQ protocol authorship and execution, FAT/SAT, requalification, cleaning and process validation, and validation-impact assessment of change controls. Experienced in deviations/CAPA, OOS/OOT investigations, FMEA-based risk assessments, and maintaining inspection readiness under 21 CFR 210/211 and EU GMP in CDMO-style multi-product environments.

CORE SKILLS

Validation & Qualification: DQ/IQ/OQ/PQ, FAT/SAT, Equipment Qualification, Facility Qualification, Process Validation, Cleaning Validation, Requalification Quality Systems: Deviations, CAPA, Change Control, OOS/OOT Investigations, Non- conformances, Root Cause Analysis, Inspection Readiness Compliance & Regulations: cGMP, GxP, 21 CFR Parts 210/211, 21 CFR Part 11, EU GMP, ICH Q8/Q9/Q10, Data Integrity, ALCOA+

Risk Management: FMEA, Risk Assessments, Impact Assessments, Trend Analysis, Minitab Statistical Analysis

Manufacturing Operations: CDMO Multi-product Manufacturing Support, Batch Production Records (BPR/MBR), SOPs, Work Instructions, Validation Plans Systems & Tools: MES, SAP PP/MM, LIMS, Waters Empower, TrackWise, MasterControl, Microsoft Office

WORK EXPERIENCE

Senior QA Validation Specialist Pfizer, Groton, CT Jan 2026 – Present

Provide technical oversight for pharmaceutical manufacturing equipment, utilities, and GMP systems to ensure reliable and compliant operations.

Lead execution and review of DQ/IQ/OQ/PQ, FAT/SAT protocols for manufacturing and laboratory equipment.

Lead investigations for Deviations, CAPA, OOS/OOT, Change Controls, and Non- conformances, performing root cause analysis, impact assessment, and effectiveness checks.

Apply FMEA, HAZOP, and technical risk assessments to evaluate equipment, process, and system risks.

Partner with Manufacturing, QA, QC, Engineering, Validation, and Regulatory Affairs to resolve technical and compliance issues.

Author and review SOPs, validation protocols/reports, risk assessments, and investigation records ensuring GMP compliance.

Support validation of computerized systems (MES, SAP, LIMS, Empower) including functionality assessment, audit trail review, and data integrity review per 21 CFR Part 11 / ALCOA+.

Support FDA/regulatory inspection and audit readiness, ensuring validation and manufacturing documentation is complete and inspection-ready. QA Validation Specialist MAK Pharma, NJ

Jan 2025 – Dec 2025

Supported day-to-day qualification and validation of manufacturing processes, utilities, equipment, and GMP systems.

Executed DQ/IQ/OQ/PQ, FAT/SAT, process validation, cleaning validation, and analytical method validation activities.

Reviewed equipment performance data to identify discrepancies, qualification gaps, and potential manufacturing impacts.

Contributed to Deviation, CAPA, OOS/OOT investigations with root cause analysis and impact assessments.

Developed and maintained URS, FS, CS, requirements traceability matrices (RTM), risk assessments, validation plans, protocols, and final reports.

Supported process and technology transfer including technical documentation and manufacturing readiness.

Applied cGMP, ALCOA+, and data integrity principles across validation lifecycle documentation.

Quality Assurance Specialist TCS, NJ

May 2021 – Oct 2023

Managed QMS elements including Deviations, CAPA, Change Controls, OOS/OOT, Non-conformances, and Customer Complaints.

Reviewed and approved GMP documentation, SOPs, specifications, and controlled documents.

Performed supplier and raw material qualification reviews to ensure manufacturing suitability.

Supported investigations through root cause analysis, impact assessment, and corrective action follow-up.

Collaborated cross-functionally to resolve documentation, quality, and operational issues impacting manufacturing.

Supported internal, client, and regulatory audits and inspection readiness activities.

Supported batch shipment/release through documentation review and verification. Senior Quality Assurance Executive Aurobindo Pharma Ltd, India Jan 2019 – Apr 2021

Executed process validation, cleaning validation, analytical method validation, and equipment qualification (DQ/IQ/OQ/PQ).

Maintained equipment lifecycle documentation for GMP manufacturing systems.

Participated in Deviation, CAPA, OOS/OOT investigations with root cause analysis and impact assessment.

Performed technical assessments of equipment and processes to identify risks and operational impacts.

Authored URS, FS, CS, risk assessments, validation plans, protocols, and reports.

Supported technology transfer projects and associated manufacturing documentation.

Drove continuous improvement initiatives for manufacturing and validation processes.

CERTIFICATIONS

Lean Six Sigma White Belt

Pharmaceutical GMP Professional

ISO 45001:2018 Occupational Health and Safety Management Systems

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