Validation Manager - Sterilisation TLNT1_NI in Newry

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.
• Conduct 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.
• 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.
• Previous experience in achieving on-time-in-full validation schedule compliance.

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.

To Apply

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