PEV Associate Director

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As the Associate Director, Process Equipment & Validation, you will oversee the lifecycle of process equipment and validation at the Dundalk site, including project delivery, qualification/validation, ongoing requalification/revalidation, and system retirement. As a key member of the Engineering Leadership Team, you will ensure activities meet GMP, GDP, data integrity (ALCOA+), corporate standards, and global regulatory requirements.
The role is accountable for customer delivery, audit readiness, and compliance excellence while building a high-performing team to support WuXi Biologics Ireland’s strategic and operational goals. This senior leadership role reports to the Senior Engineering Director.
Responsibilities Serve on the Engineering Leadership Team, contributing to site strategy, operational planning, and cross-functional decision-making.
Define and execute the Process Equipment & Validation strategy, aligned with corporate and global engineering standards.
Provide leadership to embed a compliance-first, customer-focused, delivery-driven culture and integrate engineering deliverables into commercial manufacturing operations.
Own the lifecycle of process equipment and validation activities from project initiation to commissioning, qualification, requalification, revalidation, and retirement.
Ensure technical and compliance governance for validated systems including process equipment, cleanrooms, utilities, laboratory systems, cleaning validation, thermal mapping, and computerised systems.
Lead design, specification, procurement, commissioning, qualification, and validation of GMP laboratory, utilities, computerised, manufacturing systems, and cleanroom environments for capital projects and new products.
Partner with Operations, Quality, and Project Management to deliver projects on time, within budget, and compliant with cGMP, corporate, and regulatory requirements (ISPE, ASME BPE, EHS).
Lead investigations into deviations, non-conformances, validation issues, and process equipment failures, implementing science-based, risk-focused CAPAs.
Maintain inspection readiness for process equipment and validation systems and act as SME for audits and regulatory inspections (HPRA, EMA, FDA, client audits), ensuring documentation, systems, and practices are audit-ready.
Uphold standards of Good Documentation Practice (GDP) and ALCOA+ compliance.
Provide technical support to Operations (QC, Utilities, Warehouse, Cell Culture, Purification) to ensure compliant operations.
Drive continuous improvement initiatives to enhance process reliability, reduce revalidation burden, improve efficiency, and support technical innovation.
Collaborate with Quality, Manufacturing, and Global Engineering teams for consistent delivery and customer satisfaction.
Lead, mentor, and develop a high-performing Process Engineering and Validation team, promoting accountability, technical excellence, and continuous learning.
Act as a role model for WuXi Biologics’ values and PROUD culture, ensuring staff engagement, development, and recognition.
Person Specification Proven experience establishing, developing, and scaling Process Engineering/Validation functions in greenfield or large-scale biotech environments.
Expertise in process equipment and validation lifecycle management within a cGMP-regulated biotech/biologics environment.
Knowledge of biotechnology manufacturing operations, large-scale unit operations, validation standards, and global regulatory requirements (HPRA, EMA, FDA).
Proven ability to lead project delivery, validation strategy, and audit/inspection management.
Familiarity with ASME BPE, ISPE, EHS standards, and Quality Systems.
Experience & Qualifications Degree in Life Sciences, Chemical/Biological Engineering, or related discipline.
10+ years in cGMP manufacturing or biologics process development, with significant leadership experience.
Track record of leading cross-functional teams, capital projects, regulatory inspections, and delivering complex technical programmes.
Experience delivering projects while ensuring compliance, cost-effectiveness, and business continuity.
Hands-on experience with large-scale biotech unit operations and bioprocess development.
Knowledge In-depth understanding of biochemical engineering principles, process data analysis, and GMP systems.
Familiarity with global standards including ASME BPE, ISPE, and EHS frameworks.
Strategic thinker with effective communication, stakeholder engagement, and strong execution skills.
Collaborative, inclusive, and adaptable leader who drives performance and innovation.
Ethical, proactive, and committed to continuous improvement and team development.
Inspires and develops high-performing teams through coaching and mentoring.
Strong communicator and influencer, able to build trust across functions and with senior leadership.
Acts with integrity, accountability, and a customer-first mindset.
Champions continuous improvement and compliance excellence.
Additional Requirements
Support international sites and global engineering initiatives, including audits, as needed.
Perform other duties as assigned by the Engineering Director.
WuXi Biologics is an equal opportunities employer.

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