This job has expired

Validation Engineer

Employer
Grifols
Location
Dublin, Dublin West
Salary
Negotiable
Closing date
5 Dec 2022

View more

Sector
Engineering
Job Type
Permanent
Hours
Full-time

Job Details

Validation Engineer

Grifols a Global Healthcare Company in Grange Castle in Dublin 22 is recruiting for a 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

Company

Grifols is a global company that since 1909 has enhanced the health and well-being of people around the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative solutions and services in more than 100 countries.

Grifols Worldwide Operations Ltd. was established in 2013 in Dublin, Ireland. It serves as the management center for the global Bioscience Division overseeing treasury, risk management, supply and demand planning, regulatory, R&D and commercial functions.

It also serves as a hub for labeling, packing, final conditioning and distribution of finished plasma products to Grifols' worldwide network of commercial subsidiaries and distributors, with the exception of Spain and the United States. The site will also host an Albumin purification plant which is now under construction. www.grifols.com

Grifols Plant

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