PEV Associate Director
PEV Associate Director
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Job Description
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 Directors absence delegate responsibilities to an equivalent-level lead within the department as appropriate.
WuXi Biologics is an equal opportunities employer.
Required Experience:
Director
Employment Type
Full Time
