Site Process and Cleaning Validation Lead

About the Company:

Innopharma Technical Services, part of Innopharma Group, specialises in the training and recruitment of highly skilled, project-ready, Engineers & Scientists to the (Bio) Pharmaceutical and MedTech Manufacturing Sector.

We are supporting a global life sciences client in Co. Mayo with the appointment of a senior validation leader to take ownership of site validation strategy, master planning and NPI support.

Location: West of Ireland

About the position:

This is a permanent, strategic role offering real influence across new product introduction, tech transfer and lifecycle validation, within a complex, multi-product manufacturing environment in compliance with regulatory standards and internal quality requirements.

The role will suit someone with significant experience in Process and/or Cleaning Validation who is motivated by building and shaping validation systems, not just maintaining them.

This position reports to the Director of Technical Centre.

Job Type: Permanent Role

Key Responsibilities:

• Develop and execute site validation master plans for process and cleaning validation.
• Lead the design, planning, and implementation of validation protocols (PPQ), including risk assessments and data analysis during tech transfer.
• Oversee the review and approval of validation documentation, reports, and change controls.
• Collaborate with manufacturing, engineering, and quality assurance teams to drive continuous improvement.
• Ensure compliance with global regulatory requirements (FDA, EMA, etc.) and company policies.
• Manage validation investigations, deviation reports, and corrective/preventive actions (CAPAs).
• Train site personnel on validation procedures and best practices.
• Represent the validation function in audits and regulatory inspections.
• Participate in the risk assessment process for all business units & Participate in the design review process for all business units.
• Tracking and generation of weekly metrics (GTW QMS, EHS, Compliance Wire, etc.)
• Provide support for audit preparation, direct audit interaction and involvement in audit response. Participation in the site’s internal and external audit program (to include periodic review).
• Manage revalidation schedule, regulatory affairs response, laboratory validation documentation review and APR report in conjunction with Business Unit Owner.
• Coach and Develop (including upskilling as required) direct reports to ensure provision of technical support/leadership to the site.
• Manage and motivate the employees in the function through effective communication to the management positions and their reports.
• Hold performance review meetings according to company policy, including individual development plans.
• Maintain staffing in line with business needs, including selection and recruitment.
• Develop and manage the functional budgets to meet company objectives.
• Manage non-conforming KPIs as required by putting in place robust preventative action plans

Preferred Experience:

• 9+ Years (Bachelor’s) or 7+ years (Master’s) or 5+ years (PhD) degree in a scientific or engineering discipline (Chemistry, Microbiology, Pharmacy, Chemical Engineering, or related field).
• 7+ years of experience in pharmaceutical validation (process and/or cleaning).
• In-depth knowledge of regulatory guidelines for validation (cGMP, FDA, EMA, ICH Q7/Q8/Q9/Q10).
• Strong project management, problem-solving, and organisational skills.
• Ability to work collaboratively in a cross-functional environment and manage multiple projects simultaneously.
• Excellent conflict handling skills.
• Expertise in the relevant subject matter areas –example cleaning, CSV, Aseptic, process, CPV
• Understanding of Process Validation, Computer system Validation, SCADA systems, CPV, Sterilisation, Packaging systems and related technologies.
• A strong understanding of current data integrity expectations would be a distinct advantage.
• Excellent communication and presentation skills, both written and oral, ability to present data in a clear and concise manner to team members and, where required, to management.

Note:

• Due to the nature of the business, additional duties may be required/assigned from time to time.
• All applicants must be eligible to work in Ireland.

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If you’re passionate about manufacturing excellence and eager to grow in a fast-paced, regulated environment, we want to hear from you.

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