Lead Sterilisation Validation - GMP & Compliance

Next Phase Recruitment; Northern Ireland; On-site; GBP 70,000 - 90,000; Full time

Job summary

Next Phase Recruitment is seeking an experienced Validation Manager – Sterilisation to lead sterilisation and aseptic processing validation activities in a GMP-regulated manufacturing environment. The role focuses on ownership of validation strategy, audit readiness and continuous improvement within a complex operation.

The ideal candidate has strong leadership experience in sterile pharmaceutical manufacturing, with proven knowledge of sterilisation processes and GMP requirements, and the

Qualifications

• Degree in Pharmaceutical Sciences, Engineering, Microbiology, Biotechnology, Chemistry or related discipline, or minimum of 5 years' relevant industry experience.
• Strong experience within a sterile pharmaceutical manufacturing environment.
• Proven knowledge of sterilisation processes and aseptic manufacturing.
• Strong understanding of GMP requirements relating to sterile manufacturing and validation.
• Previous experience leading or supervising teams within a laboratory or manufacturing environment.

Responsibilities

• Lead and manage the Sterilisation and Aseptic Processing Validation team.
• Plan, coordinate and prioritise validation activities to ensure timely project delivery.
• Drive the completion of deviations, investigations, CAPAs, risk assessments and change controls.
• Review and approve validation protocols, reports, validation master plans and SOPs.
• Partner with cross-functional teams to embed validation requirements into business and capital projects.
• Provide technical expertise across sterilisation, aseptic processing and validation best practice.
• Support the introduction of new equipment, facilities and processes requiring sterilisation or aseptic validation.
• Mentor, coach and develop team members to strengthen technical capability.
• Promote validation standards across the wider organisation through effective stakeholder engagement.
• Support internal, customer and regulatory audits and inspections.
• Contribute to compliance, continuous improvement and operational excellence initiatives.
• Ensure all activities are conducted in line with health and safety requirements.

Skills

Sterilisation

Aseptic processing

Validation

GMP knowledge

Leadership

Stakeholder engagement

Education

Pharmaceutical Sciences or related

Job description

Next Phase Recruitment is seeking an experienced Validation Manager – Sterilisation to lead sterilisation and aseptic processing validation activities in a GMP-regulated manufacturing environment. The role focuses on ownership of validation strategy, audit readiness and continuous improvement within a complex operation.

The ideal candidate has strong leadership experience in sterile pharmaceutical manufacturing, with proven knowledge of sterilisation processes and GMP requirements, and the