Job Summary
The Process Engineering Leader will oversee the lifecycle of process equipment and validation at our site. Key responsibilities include ensuring activities meet GMP, GDP, data integrity, corporate standards, and global regulatory requirements.
Key Responsibilities:
* Serve on the cross-functional team contributing to site strategy, operational planning, and decision-making.
* Define and execute the process equipment and 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 computerized systems.
* Lead design, specification, procurement, commissioning, qualification, and validation of GMP laboratory, utilities, computerized, 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), 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.