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Validation Engineer

Location: 

Dublin, IE

Contract Type:  Regular Full-Time
Area:  Manufacturing
Req Id:  232828

Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.

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 two years hands-on validation experience preferred.

 

 

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.

 

  • 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

 

 

REQUIREMENTS

 

 

  • Strong communication / presentation skills during internal/external audits
  • 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

 

  • Experience in representing client companies during internal (Corporate) audits and external (FDA and HPRA) audits an advantage
  • Working knowledge of HTM 01 (Part C, Steam Sterilization) Autoclaves an advantage
  • Familiarity with ISO-14644 (Cleanrooms and Associated Environments) an advantage
  • Familiarity with Annex 1 (Manufacture of Sterile Medicinal Products) an advantage
  • Experience within aseptic manufacturing environment an advantage

 

 

 

 

Location: EMEA : Ireland : Dublin:Grange Castle (Dublin) 

 

Learn more about Grifols