Validation Engineer

  • Dublin
  • Grifols
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. At Grifols, we believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunities that foster an inclusive environment. Position Summary : Represent the Validation team as a Validation Engineer position for Validation projects Plan and implement Validation strategies for major capital projects Represent Validation at technical forum include external and internal audits. Write, review and execute Validation Plans ,Protocols and Reports for the new GWWO 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. What your responsibilities will be: Write, review and execute Validation Protocols and Reports (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 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. What you will bring to the role: Project Management Experience 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 and/or Min 4 years Validation experience Experience in representing client companies during internal (Corporate) audits and external (FDA and HPRA) audits Working knowledge of HTM 01 (Part C, Steam Sterilization) Autoclaves Familiarity with ISO-14644 (Cleanrooms and Associated Environments) Familiarity with Annex 1 (Manufacture of Sterile Medicinal Products) Experience within aseptic manufacturing environment Key Competencies: (if applicable) Packaging Equipment Project Management skills 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. Our Benefits Include: Highly competitive salary Group pension scheme - Contribution rates are 5% employer and 5% employee Private Medical Insurance for the employee Ongoing opportunities for career development in a rapidly expanding work environment Education allowance Wellness activities - Social activities eg. Golf, Padel, Summer Event If you’re interested in joining our company and you have what it takes, then don’t hesitate to apply.We look forward to receiving your application. Location: