PEV Associate Director

As the Associate Director, Process Equipment & Validation you will be responsible for the end-to-end lifecycle of process equipment and validation activities at the Dundalk site. This includes project delivery, qualification/validation, sustaining requalification/revalidation, and eventual system retirement.

As a key member of the Engineering leadership team, the role ensures that all validation and process equipment activities are executed to the highest standards of GMP, GDP, data integrity (ALCOA+), corporate requirements, and global regulatory expectations.

The role also carries critical accountability for customer delivery, audit readiness, and compliance excellence, while building and developing a high-performing team that enables WuXi Biologics Ireland to meet strategic business and operational objectives.

This is a senior leadership role within the Engineering function reporting to the Senior Engineering Director.

Responsibilities

Leadership & Strategy

• Act as a core member of the Engineering Leadership Team, contributing to site strategy, operational planning, and cross-functional decision making.
• Define and execute the Process Equipment & Validation strategy, ensuring alignment with corporate and global engineering standards.
• Provide visible leadership to embed a compliance-first, customer-focused, and delivery-driven culture.
• Ensure seamless integration of engineering deliverables into commercial manufacturing operations.

Full Lifecycle Accountability

• Own the full lifecycle of process equipment and validation activities, from project initiation through to commissioning, qualification, routine requalification, revalidation, and retirement.
• Ensure robust technical and compliance governance of all validated systems, including process equipment, cleanrooms, clean utilities, laboratory systems, cleaning validation, thermal mapping, and computerised systems.
• Maintain validated state of control across clean utilities, cleaning validation, laboratory systems, thermal mapping, and computerized systems.

Project Delivery & Execution

• Lead the design, specification, procurement, commissioning, qualification, and validation of GMP laboratory, utilities, computerised systems, manufacturing systems etc and cleanroom environments in support of capital projects and new product introductions.
• Partner with Operations, Quality, and Project Management to ensure projects are delivered on time, within budget, and fully compliant with GMP and regulatory expectations.

Compliance, Audit & Inspection Readiness

• Ensure all engineering and validation activities meet cGMP, corporate, and regulatory requirements (e.g., ISPE, ASME BPE, EHS).
• Lead investigations and resolution of deviations, non-conformances, and technical issues using science-based approaches.
• Ensure inspection readiness at all times for process equipment and validation systems.
• Act as Subject Matter Expert (SME) and ensure SMEs within the PEV team for audits and regulatory inspections (HPRA, EMA, FDA, client audits), ensuring documentation, systems, and practices are audit-ready, and any follow up / corrective actions are timely, robust, and sustainable.
• Maintain world-class standards of Good Documentation Practice (GDP) and compliance with ALCOA+ principles.

Operational Support & Continuous Improvement

• Provide expert technical support to Operations (QC, Utilities, Warehouse, Cell Culture, Purification etc) to ensure robust, validated, and compliant operations.
• Lead investigations into deviations, validation issues, and process equipment failures, driving science-based, risk-focused resolutions and CAPA implementation.
• Drive continuous improvement initiatives to enhance process reliability, reduce revalidation burden, and improve efficiency.

Technical Excellence & Customer Focus

• Provide expert support to manufacturing operations, particularly in cell culture and purification processes.
• Drive technical innovation and continuous improvement initiatives to enhance equipment reliability, process robustness, and product quality.
• Collaborate with Quality, Manufacturing, and Global Engineering teams to ensure consistent delivery and customer satisfaction.

Team Development & Management

• Lead and mentor a high-performing team of Process Engineers and Validation professionals.
• Promote a culture of accountability, technical excellence, and continuous learning.
• Act as a role model for WuXi Biologics’ core values and PROUD culture, ensuring staff are engaged, developed, and recognised.

Person Specification

Technical Competencies

• Proven experience establishing, development of and scaling Process Engineering/Validation functions in greenfield or large-scale biotech environments.
• Demonstrated expertise in process equipment and validation lifecycle management within a cGMP-regulated biotech/biologics environment.
• Strong knowledge of biotechnology manufacturing operations, large-scale unit operations, validation standards, and global regulatory requirements (HPRA, EMA, FDA).
• Proven ability to lead in 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.
• Demonstrated track record of leading cross-functional teams, capital projects, regulatory inspections and delivering complex technical programs.
• Proven ability to deliver complex projects while ensuring compliance, cost-effectiveness, and business continuity.
• Hands-on experience with large-scale biotech unit operations and bio-process 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.
• Leadership & Behavioural Competencies
• Strategic thinker with effective communication and stakeholder engagement skills and strong execution capability.
• 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.
• In the Associate Director’s absence, delegate responsibilities to an equivalent-level lead within the department, as appropriate.

WuXi Biologics is an equal opportunities employer.