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Senior Validation Specialist

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PCI Pharma Services

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Location:
Ireland , Stamullen, Co. Meath

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Category:
Quality Control

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

The role of the Senior Validation Specialist is to implement and execute tasks relating to operational support for product launches, Process, Facility and Equipment Development at PCI Pharma Services sites.

Job Responsibility:

  • Support the validation effort for all Strategic Projects on site
  • Ensure all validation activities on site relating to Facility, Equipment and Processes meet the expectations of clients but more specifically meet regulatory requirements (HPRA/ FDA)
  • Prepare, review and or approval of qualification and/or validation documentation (VMPs, specifications, protocols, reports etc.) in relation to instrument, equipment, facilities (including cold stores), utilities, automated systems, manufacturing processes and cleaning processes including FAT, SAT, IQ, OQ, PQ phases in conjunction with program Quality representation
  • Drive solutions, in conjunction with the appropriate department, to ensure customer related validation problems are communicated and corrective actions are in place and closed in a timely manner
  • Thorough investigation of Quality and Validation issues using Root Cause Analysis methodology and implementation of robust corrective and preventative actions to prevent recurrence
  • Support change controls as required
  • Execute validation activities, with minimal supervision, in conjunction with Technical, Production and Engineering functions
  • Ensure the strict implementation of validation procedures plus the timely and accurate completion of all validation documentation
  • Supports the coordination & scheduling of packaging validation activities in alignment with planning & packaging functions
  • Perform Periodic reviews, revalidations, and continued process verifications on a scheduled basis
  • Support all Regulatory Inspections, Customer visits and Customer audits on validation related queries as required

Requirements:

  • Min 3 years' Quality experience
  • Min 2 years' Validation experience
  • Equipment Qualification (IQ, OQ, PQ) – Hands on experience in protocol generations, execution, completion
  • Process Validation (PV) experience
  • New Product Introduction (NPI) - Generation, execution and close out of validation projects
  • Communication Customer/Internal stake holders/Suppliers
  • Experience with deviation, CAPA processes
  • Flexible and able to manage multiple priorities simultaneously
  • Periodic reviews

Nice to have:

  • Experience with packaging - secondary packaging / blister packaging and high speed / automated lines would be a distinctive advantage for this position
  • Ability to present risk-based project validation strategy in a clear and concise manner to the Business Unit Planners, Customers and where required, to senior management
  • Decision Making: Identify and understand issues, problems and opportunities whilst providing a viable solution
  • Passion for Results: high energy, maturity, ability to work under pressure and deliver results
  • get things done (an action-oriented approach)
  • Cleaning Validation (CV)
  • Computer Systems Validation (CSV)
  • Temperature mapping
  • FAT, SAT

Additional Information:

Job Posted:
February 20, 2026

Employment Type:
Fulltime
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