Process Validation Manager

Grifols, S.A; Dublin; On-site; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Competitive salary package

Group pension scheme

Private medical insurance

Education & development allowance

Wellness and social initiatives

Job summary

Grifols, S.A. is seeking a senior validation professional to lead and manage the process validation staff and consultants.

You will coordinate new validation projects, tech transfers and equipment validation to ensure compliance with global and local standards. Responsibilities include developing the team, planning complex validation efforts, writing validation protocols and reports, and contributing to control strategy documentation.

Qualifications

• Formal degree in Science or Engineering; minimum 5 years Validation experience.
• Experience in pharma validation, aseptic manufacturing, and quality systems.
• Familiarity with HTM 01 Autoclaves and ISO-14644 helpful.

Responsibilities

• Develop and educate the process validation team and continuously improve processes.
• Resource projects and plan complex validation schedules.
• Write, review and execute Validation Protocols/Reports for aseptic processes.
• Generate and review tech transfer documentation and CCS input.
• Contribute to site SOPs for CPV, VHP, SIP and autoclave validation.
• Perform risk assessments and drive CAPA closures.
• Troubleshoot issues and propose changes or improvements.

Skills

Project Management

Tech transfer documentation

Process validation

Aseptic environment

CPP / CQA char.

Cleaning validation

PPQ studies

cGMP knowledge

Cross-department coordination

Education

Degree in Science/Engineering

Min 5 years Validation experience

Tools

Word

Excel

Access

Job description

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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


• 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

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