Validation Manager, Sterilisation

NorbrookNewry, DownPermanent

Main Activities/Tasks

Provide leadership, guidance and performance management to the Sterilisation and Aseptic processes validation team with respect to validation at the Norbrook sites.
Conducting meetings with the team of Validation Analysts to ensure validation activities are scheduled, prioritised and completed within agreed timelines, and that company/departmental communications are relayed within the team.
Drive timely completion of deviations, change control actions, risk assessments, OOS investigations and CAPAs associated with Validation Activities.
Ensure Validation Protocols, Reports, Standard Operation Procedures, Validation Master Plans and associated technical documentation are prepared, reviewed and approved in line with current GMP and regulatory requirements.
Communicate status of validation projects to ensure effective cross-functional collaboration ensuring validation requirements are incorporated into business projects.
Provide leadership and guidance to the team with respect to sterilising and aseptic process validation strategy and industry standards.
Identify training requirements and ensure the validation team remain competent in current GMP, sterilisation technologies and regulatory expectations.
Support introduction of new equipment, facilities, products requiring sterilisation or aseptic validation.
Mentor the direct reports as assigned and ensure that they are appropriately trained and performing their functions.
Attend meetings within the organisation to promote the validation requirements and timelines required to achieve validation activities. Such meetings will include specific project meetings.
To ensure that Health and Safety practices and procedures are followed in the incumbent’s area of responsibility.
Provide technical support and participate in internal, external and regulatory audits/inspections.
Participate in company compliance and continuous improvement projects as requested.
Undertake any other duties as deemed necessary by Norbrook line management

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

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

The closing date for applications is Friday the 14th of August 2026

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