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.
POSITION SUMMARY: Represent the Validation team as a Technical Lead and Lead position for Validation projects.
You will plan and implement Validation strategies for major capital projects and represent Validation at technical forums including external and internal audits.
You'll write, review and execute Validation Plans, Protocols, and Reports for the new GWWO ensuring compliance with all relevant global and local quality and validation procedures/standards.
Initial requirements will focus on the areas of Equipment, Utilities, CSV, and Cleanroom Validation.
KEY RESPONSIBILITIES: Write, review and execute Validation Protocols and Reports (for Equipment, Utilities, Processes, Cleaning, Temperature Mapping, and Equipment Software) ensuring compliance with all relevant global and local quality and validation procedures/standards.Review change controls and assess the 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.Generate and review project documentation (User Requirement Specifications, validation protocols, reports, etc.)
and Standard Operating Procedures.Support 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 VMPs, defining the validation approach associated with each piece of equipment, system, process, and the requalification requirements including study requirements and frequency.
Execute/Coordinate Re-Validation activities as required.Complete risk assessments, closure of corrective and preventive actions.Investigate and troubleshoot problems and determine solutions or recommendations for changes and/or improvements.Perform other validation-associated activities as defined by Manager or Director.KEY COMPETENCIES Packaging EquipmentComputer System ValidationClean UtilitiesCalibrationAutoclave / Thermal MappingProcess and Cleaning ValidationCommissioning and QualificationDocumentation (Writing SOPs, Protocols, Reports)Clean Room QualificationAuditingPERSON SPECIFICATION Project Management ExperienceHands-on knowledge of execution of ValidationExperience in a Quality or Validation Role within the Pharma sectorExperience with Software validation for manufacturingExcellent 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 experienceExperience in representing client companies during internal (Corporate) audits and external (FDA and HPRA) auditsWorking knowledge of HTM 01 (Part C, Steam Sterilization) AutoclavesFamiliarity with ISO-14644 (Cleanrooms and Associated Environments)Familiarity with Annex 1 (Manufacture of Sterile Medicinal Products)Experience within aseptic manufacturing environmentOur Benefits Include: Highly competitive salaryGroup pension scheme - Contribution rates are 5% employer and 5% employeePrivate Medical Insurance for the employeeOngoing opportunities for career development in a rapidly expanding work environmentSuccession planning and internal promotionsWellness activities - Social activities e.g.
Padel, Summer EventWe understand that self-doubt can hold talented individuals back from applying for opportunities.
We encourage everyone who meets the qualifications to apply – we're excited to hear from you.
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