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Validation Engineer in Ireland

Manpower Ireland

Validation Engineer

Write, review and execute Validation Protocols and Reports for the new GWWO Albumin Purification and Aseptic Filling Plant ensuring compliance to all relevant global and local quality and validation procedures /standard. Initial requirements to focus on the areas of Equipment, Utilities, CSV and Cleanroom Validation.

Minimum four years hands-on validation experience preferred. Previous experience in setting up cleaning strategies , including determining maximum carry over limits.

Advantage of previous process validation experience in sterile manufacturing.

Understanding Annex 1 requirement for Filter Validation and Extractable and Leachable studies .

Key Responsibilities

  • Write, review and execute Validation Protocols and Reports for the new Albumin Plant (for Equipment, Utilities, Processes, Cleaning, Temperature Mapping and Equipment Software) ensuring compliance to all relevant global and local quality and validation procedures/standards
  • Review change controls and assess impact of changes that affect validated systems and define validation requirements
  • Represent Validation at both internal and external audits by regulatory agencies, including HPRA and FDA.
  • Generation and review of project documentation (User Requirement Specifications, validation protocols, reports etc.) and Standard Operating Procedures.
  • Supporting validation activities including review of documentation and hands-on execution of validation activities (FAT, SAT, IQ, OQ, PQ etc) to ensure equipment meets current GMP requirements and industry standards.
  • Maintain the Site Validation Master Plan (VMP) and associated Project VMP’s, defining the validation approach associated with each piece of equipment, system, process and the requalification requirements including study requirements and frequency. Execute/Co-ordinate Re-Validation activities as required.
  • Completion of risk assessments, closure of corrective and preventive actions.
  • Investigates and troubleshoots problems and determines solutions or recommendations for changes and/or improvements.
  • Performs other validation associated activities as defined by Manager or Director

Key Competencies:

  • Computer System Validation
  • Clean Utilities
  • Calibration
  • Autoclave / Thermal Mapping
  • Process and Cleaning Validation
  • Commissioning and Qualification
  • Documentation (Writing SOPs, Protocols, Reports)
  • Clean Room Qualification
  • Auditing
  • Strong communication / presentation skills during internal/external audits.

Key Skills & Knowledge:

  • Hands on knowledge of execution of Validation
  • Experience in a Quality or Validation Role within Pharma sector
  • Experience with Software validation for manufacturing
  • Excellent Technical Writing and analytical skills.
  • Familiarity with cGMPs and industry and federal guidelines required.
  • Experience with Word, Excel and Access computer applications.
  • Strong interpersonal skills for interactions with other departments.
  • Degree in Science/Engineering

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