Job description:
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.
Leadership & Behavioural Competencies
* 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.
* In the Associate Director's absence, delegate responsibilities to an equivalent-level lead within the department, as appropriate.
WuXi Biologics is an equal opportunites employer.