Process Validation Manager

Grifols Shared Services North America, Inc; Dublin; On-site; EUR 90,000 - 130,000; Full time

Benefits offered by this job

Group pension scheme

Private medical insurance

Education allowance

Wellness and social events

Job summary

Grifols requires an experienced process validation leader to manage the validation staff and consultants, delivering New process validation, tech transfer, and qualification projects in aseptic environments at Grange Castle, Dublin.

The role demands strong project management, QA/CFD knowledge, and hands-on execution of CPV/SIP/Autoclave validation, with a focus on risk assessments, CAPA closure, and cross-functional collaboration with audits.

Qualifications

• Degree in Science/Engineering or equivalent.
• Experience in process validation and aseptic environments.
• Strong QA and regulatory awareness (FDA/HPRA).

Responsibilities

• Develop and educate the process validation team and continuously improve processes.
• Direct reports and consultants management.
• Resource, plan and schedule complex validation projects.
• Write, review and execute Validation Protocols and Reports for aseptic processes.
• Generate and review tech transfer docs and CCS input.
• Develop site validation SOPs per CPV, VHP and SIP guidance.
• Complete risk assessments and close CAPAs.
• Investigate issues and recommend improvements.
• Perform other validation activities as directed by validation director.

Skills

Project Management

Tech Transfer Docs

Process Validation

Aseptic Processes

Quality Audits

cGMP knowledge

Team Leadership

Analytical Writing

Education

Science/Engineering degree

Tools

Word

Excel

Access

Job description

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 process and change control projects are resourced and delivered to schedule. Responsible for the co-ordination and delivery of: New process validation and Technical Transfer 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 Do:

• Develop and educate the process validation team and continuously improve process validation processes.
• Responsible of 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) 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.

What You’ll Bring

• Project Management
• Experience of tech transfer documentation creation, and knowledge of process design documentation (CPP /CQA characterisation) Process validation experience in aseptic filling and or drug substance processes
• Strong communication / presentation skills during internal/external audits.
• Some knowledge of cleaning validation and SIP preferable
• Direct people management experience (preferably at least 3 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 5 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:

• A highly competitive salary package
• Group pension scheme - Contribution rates are (3%/ 5%/ 7%) and company will match
• Private medical insurance for the employee
• Ongoing career development opportunities within a rapidly growing organisation
• Strong focus on succession planning and internal promotion
• Dedicated education and professional development allowance
• Wellness and social initiatives, including activities such as padel and summer events

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Location:

Grange Castle International Business Park, Grange, Co. Dublin, D22 K2R3 ( more about Grifols

Type:

Regular Full-Time