Validation Technical Engineer Lead

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 forum include external and internal audits.  You'll  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.  

KEY RESPONSIBILITIES:

• 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 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

• 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. 

PERSON SPECIFICATION

• 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

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
• Succession planning and internal promotions
• Education allowance
• Wellness activities - Social activities eg. Padel, Summer Event

We 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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Location: Grange Castle (Dublin) 

 Location: Grange Castle (Dublin) 

Learn more about Grifols