Senior Bioprocess Validation Lead
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We are seeking an experienced and skilled Senior Bioprocess Validation Lead to oversee the lifecycle of process equipment and validation at our site. This key member of our Engineering Leadership Team will ensure activities meet global regulatory requirements, corporate standards, and GMP.
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Key Responsibilities:
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* Oversight of process equipment and validation lifecycle management;
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* Leadership of cross-functional teams for project delivery, audit/inspection management, and technical programme execution;
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* Development and implementation of compliance-first culture, customer-focused delivery, and integrated engineering deliverables into commercial manufacturing operations;
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* Technical governance for validated systems, including process equipment, cleanrooms, utilities, laboratory systems, cleaning validation, thermal mapping, and computerised systems;
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* Partnership with Operations, Quality, and Project Management for timely, budget-friendly, and compliant project delivery;
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* Investigation and resolution of deviations, non-conformances, validation issues, and process equipment failures;
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* Collaboration with Quality, Manufacturing, and Global Engineering teams for consistent delivery and customer satisfaction;
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* Leadership, mentorship, and development of a high-performing Process Engineering and Validation team, promoting accountability, technical excellence, and continuous learning;
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* Acting as a role model for our company values and PROUD culture, ensuring staff engagement, development, and recognition.
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Requirements:
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* Proven experience establishing, developing, and scaling Process Engineering/Validation functions in greenfield or large-scale biotech environments;
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* Expertise in process equipment and validation lifecycle management within a cGMP-regulated biotech/biologics environment;
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* Knowledge of biotechnology manufacturing operations, large-scale unit operations, validation standards, and global regulatory requirements;
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* Proven ability to lead project delivery, validation strategy, and audit/inspection management;
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* Experience delivering projects while ensuring compliance, cost-effectiveness, and business continuity;
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* Hands-on experience with large-scale biotech unit operations and bioprocess development;
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* Leadership & Behavioural Competencies: strategic thinking, effective communication, stakeholder engagement, and strong execution skills, collaborative leadership, inclusive, adaptable, ethical, proactive, and committed to continuous improvement and team development;
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* Degree in Life Sciences, Chemical/Biological Engineering, or related discipline;
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* 10+ years in cGMP manufacturing or biologics process development, with significant leadership experience;
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* Track record of leading cross-functional teams, capital projects, regulatory inspections, and delivering complex technical programmes.
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Benefits:
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* Bonus
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* Life Assurance
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* Pension
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* VHI
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