Validation Manager, Sterilisation

Job Overview

Reporting to the Head of Validations, the Validation Manager - Sterilisation leads the Sterilisation and Aseptic Processing Validation function, ensuring validation activities comply with GMP requirements, regulatory expectations, and company quality standards. You will provide technical leadership for sterilisation, aseptic processing, and contamination control validation, maintaining the validated state through lifecycle management, change control, periodic review, continuous improvement, and inspection readiness

Main Activities/Tasks

• Provide leadership, guidance, and performance management to the Sterilisation and Aseptic Process Validation team.
• Ensure validation activities are planned, prioritised, and completed on time, with company and departmental communications effectively shared.
• Drive timely completion of deviations, change controls, risk assessments, OOS investigations, and CAPAs related to validation activities.
• Ensure validation protocols, reports, SOPs, Validation Master Plans, and technical documentation are prepared, reviewed, and approved in line with GMP and regulatory requirements.
• Communicate validation project status to support effective cross-functional collaboration and integration of validation requirements into business projects.
• Identify training needs and maintain team competency in GMP, sterilisation technologies, and regulatory expectations.
• Support the introduction of new equipment, facilities, and products requiring sterilisation or aseptic validation.
• Mentor direct reports, ensuring they are trained, competent, and performing effectively.
• Attend organisational and project meetings to promote validation requirements and timelines.
• Ensure compliance with Health & Safety procedures.
• Provide technical support and participate in internal, external, and regulatory audits and inspections.
• Support company compliance and continuous improvement initiatives.

Essential Criteria:

• Degree in Pharmaceutical Sciences, Engineering, Microbiology, Biotechnology, Chemistry or a related discipline, OR at least 5 years relevant industry experience
• Proven experience and knowledge of sterile manufacturing, including sterilisation & aseptic processing
• Comprehensive Knowledge of GMP, specifically in relation to sterile manufacturing and sterilisation processes
• Excellent organisational and planning skills, with the ability to communicate effectively across all organisational levels.
• Previous experience in leading staff in a laboratory or manufacturing setting.
• Demonstrated understanding of sterilisation and aseptic validation standards for both EU and US

Desirable Criteria:

• Understanding of criteria to achieve successful porous load sterilisation, fluid load sterilisation, dry heat sterilisation,depyrogenation and sterilisation by radiation
• Pervious experience in achieving on-time-in-full validation schedule compliance

Duration: Permanent
Location: Newry

Additional Information:

• Applicants must have the right to work in the UK for this role. Norbrook does not provide visa sponsorship for this position. Where an applicant's current right to work is time-limited, they must be able to maintain their right to work without employer sponsorship.
• We regret that applications received after the closing date and time will not be accepted.
• This role is based on a site that produces penicillin and as such, would not be suitable for those with a penicillin allergy.

Benefits:

• Free life assurance
• Pension salary sacrifice scheme with 5% employer contribution
• Healthcare cash plan
• 32 days annual leave (increasing with length of service)
• Wedding leave
• Enhanced Maternity / Paternity Pay
• Company Sick Pay
• Subsidised Canteen Facilities
• FREE On-site parking
• Cycle to Work Scheme
• Tech Purchase Scheme
• Free Will-Writing Service
• Employee perks/discounts scheme
• Employee Assistance Programme (EAP)
• Employee well-being initiatives
• Employee recognition scheme
• Career development opportunities