Process validation and change control manager

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:

Responsible for the daily management of the process validation staff and consultants .Ensures Capex projects and change control projects are resourced ,and delivered to schedule .

Responsible for the co-ordination and delivery of  :

• New cleaning validation projects / optimisations
• New steaming validation projects / optimisations
• Product qualification and technical transfers to the site
• New process equipment / updates , including CSV elements
• Data integrity assessments for new process equipment and software

What you will be doing?  

• Develop and educate  the process validation team , and continuously improve process validation processes.
• Responsible of 2-3 direct reports and consultants
• Ability to resource projects and plan and schedule complex validation projects
• Write, review and execute Validation Protocols and Reports (for, Aseptic Processes,  steaming and cleaning validation ) ensuring compliance to all relevant global and local quality and validation procedures/standards
• Generation and review of tech transfer documentation , and development /input into control strategy documentation (CCS) 
• Development and input into site based validation SOPS to latest regulations for CPV , VHP and  SIP and autoclave validation .
• 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 validation director.
• Project Management skills
• Experience of tech transfer documentation creation ,and knowledge of process design documentation ( CPP /CQA characterisation)
• Autoclave / Thermal Mapping
• Process validation experience in aseptic filling and or drug substance processes
• Strong communication  / presentation skills during internal/external audits.
• Some knowledge of cleaning validation preferable 

Who we are looking for 

• Project Management Experience
• Direct people management experience ( preferably at least 2 years
• Hands-on knowledge of execution of Process Validation in drug substance and or aseptic environments 
• Experience with cleaning /steaming and PPQ studies
• Understanding of technical transfer process ,and CQA’s /CPP’s
• Strong FUE qualification experience (4+ years)
• Experience in a Quality or Validation Role within Pharma sector
• Experience with Software validation for manufacturing
• Good communication and co-ordination skills set
• 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 (1.5% / 3%/ 5%/ 7%) and company will match
• 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 Events
   

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 International Business Park, Grange, Co. Dublin, D22 K2R3  

Learn more about Grifols