Process Validation Manager

Grifols, S.A; Dublin; On-site; EUR 70,000 - 100,000; Full time

Benefits offered by this job

Pension scheme

Private medical insurance

Career development

Succession planning

Education allowance

Wellness & events

Job summary

Grifols in Ireland seeks an experienced Validation Lead to manage the process validation staff and consultants, ensuring projects are resourced and delivered on schedule. You will coordinate new process validation and tech transfer activities across aseptic filling and drug substance processes.

You will develop the team, write and review validation protocols and reports, and ensure compliance with cGMPs and regulatory standards. Strong writing and project management skills are essential.

Qualifications

• Degree in science/engineering required with strong validation background.
• Experience in aseptic filling and drug substance processes.
• Proven knowledge of process validation and tech transfer documentation.

Responsibilities

• Develop and educate the process validation team and continuously improve validation processes.
• Manage direct reports and consultants.
• Resource projects and plan complex validation timelines.
• Write, review and execute Validation Protocols and Reports for aseptic processes.
• Generate and review tech transfer documentation and CCS.
• Contribute to site validation SOPs following CPV, VHP and SIP regulations.
• Complete risk assessments and close CAPAs.
• Investigate issues and implement improvements.
• Lead validation activities across pharmaceutical operations.

Skills

Project Management

Tech transfer docs

CPP/CQA

Process validation

Aseptic filling

Drug substance processes

Cleaning validation

SIP

cGMPs

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
• 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