Sr. Validation Specialist

PCI Pharma Services

3+ years quality experience
2+ years validation experience
Equipment qualification iq oq pq
The Senior Validation Specialist implements operational support for product launches, facility development, and equipment qualification at PCI Pharma Services sites

Job Summary

  • The Senior Validation Specialist implements operational support for product launches, facility development, and equipment qualification at PCI Pharma Services sites.
  • This role ensures all validation activities meet strict regulatory requirements from the HPRA and FDA while managing documentation for instruments, utilities, and manufacturing processes.
  • Candidates must drive root cause analysis for quality issues and coordinate periodic reviews, revalidations, and continued process verifications with minimal supervision.

Matching Summary

The Senior Validation Specialist implements operational support for product launches, facility development, and equipment qualification at PCI Pharma Services sites.

Skills & Requirements

Must-have

  • 3+ years Quality experience
  • 2+ years Validation experience
  • Equipment Qualification IQ OQ PQ
  • Process Validation PV experience
  • New Product Introduction NPI execution
  • Deviation and CAPA process management

Nice-to-have

  • Packaging validation expertise
  • Risk-based project strategy presentation
  • High speed automated line knowledge
  • Cleaning Validation CV experience
  • Computer Systems Validation CSV
  • Temperature mapping FAT SAT

Key Requirements

  • Minimum 3 years Quality experience
  • Minimum 2 years Validation experience
  • Hands-on Equipment Qualification (IQ, OQ, PQ)
  • Experience with deviation and CAPA processes

Work Rights

Not specified

Tailored Resume

Cover Letter