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.