Key responsibilities.  

• Leadership & Organizational Development 

• Lead, mentor, and develop a multidisciplinary engineering team. 

• Establish departmental objectives, priorities, and performance metrics. 

• Develop engineering succession plans and organizational capability. 

• Allocate engineering resources across manufacturing support, capital projects, validation activities, and continuous improvement initiatives. 

• Serve as the engineering representative on site leadership teams. 

• Provide engineering leadership for process safety, containment systems, and mechanical integrity programs supporting HPAPI and API manufacturing operations. 

• Conduct performance management, coaching, development planning, and talent assessment activities for engineering personnel 

• Facilities, Utilities & Infrastructure 

• Provide technical ownership of site facilities and utility systems. 

• Ensure facility and utility systems are maintained in a compliant and reliable state. 

• Support facility expansion, renovation, and infrastructure improvement projects. 

• Maintain long-range plans for facility and utility capacity to support business growth. 

• Ensure utility systems are capable of supporting current and future manufacturing requirements. 

• Equipment Reliability & Asset Management 

• Establish and maintain equipment reliability programs. 

• Develop maintenance strategies that maximize equipment uptime and performance. 

• Ensure preventive and predictive maintenance programs are effective and risk based. 

• Lead investigations and root cause analyses for significant equipment failures. 

• Develop life-cycle plans for critical manufacturing assets. 

• Ensure appropriate spare parts and obsolescence management strategies are maintained. 

• Engineering Project Management 

• Develop and maintain the site capital investment plan. 

• Prepare project justifications, scope documents, budgets, and capital requests. 

• Manage engineering projects from concept through commissioning and qualification. 

• Ensure projects are executed safely, on schedule, within budget, and in compliance with site requirements. 

• Coordinate engineering activities with manufacturing, quality, validation, and supply chain organizations. 

• Own the engineering operating budget and capital expenditure budget, ensuring effective allocation of resources and achievement of financial objectives. 

• Develop and maintain the site facilities master plan to support current operations and future business growth. 

• Validation & Engineering Compliance 

• Ensure engineering systems, equipment, and utilities are appropriately qualified and maintained in a validated state. 

• Review and approve engineering-related validation documentation. 

• Support deviation investigations, CAPAs, change controls, risk assessments, and quality systems. 

• Ensure engineering documentation and equipment records are accurate, complete, and inspection-ready. 

• Instrumentation & Controls 

• Provide oversight of instrumentation, automation, PLC, SCADA, and building management systems. 

• Ensure control systems remain reliable, secure, and compliant with applicable requirements. 

• Support automation improvements that enhance reliability, safety, and operational efficiency. 

• Manufacturing Support 

• Provide engineering support for manufacturing operations. 

• Troubleshoot facility, utility, equipment, and process-related issues. 

• Support production continuity through timely resolution of engineering issues. 

• Partner with manufacturing teams to improve safety, quality, compliance, and productivity. 

• New Project & Technology Transfer Support 

• Assess facility readiness for new customer projects and technology transfers. 

• Evaluate utility capacity, equipment capability, containment requirements, and materials of construction. 

• Identify facility modifications or capital investments required to support new programs. 

• Support commissioning, qualification, and startup activities associated with new equipment and facility modifications. 

• Regulatory, Quality Customer Audit & Inspection Support 

• Serve as engineering subject matter expert during customer audits and regulatory inspections. 

• Support responses to engineering-related observations and commitments. 

• Ensure engineering systems are maintained in an inspection-ready state. 

• CAPA and Deviation resolution 

• Operational Excellence 

• Identify and implement continuous improvement initiatives. 

• Support equipment reliability, energy reduction, cost savings, and productivity improvement programs. 

• Utilize Lean, Six Sigma, and problem-solving methodologies to improve engineering performance. 

• Develop and monitor engineering KPIs related to reliability, maintenance, project execution, compliance, and cost performance. 

• Contractor & Vendor Management 

• Manage engineering contractors, consultants, and service providers. 

• Lead technical evaluations and selection of engineering equipment and services. 

• Ensure contractor activities are performed safely and in accordance with GMP and site requirements. 

• Other duties as assigned 

Education & Experience 

• Required 

• Bachelor's Degree or Higher in Chemical Engineering, 

• Minimum eight (8) years of experience in pharmaceutical, biotechnology, chemical, or other regulated manufacturing environments. 

• Experience leading engineering teams and technical professionals. 

• Experience supporting GMP manufacturing facilities, utilities, and process equipment. 

• Experience managing capital projects and engineering budgets. 

• Strong knowledge of FDA, cGMP, OSHA, EPA, and applicable industry regulations. 

• Experience with equipment qualification and validation programs. 

• Strong technical troubleshooting and problem-solving skills. 

• Preferred 

• Advanced degree in Engineering, or additional degree Science, or Business. 

• Project Management Professional (PMP) certification. 

• Lean Six Sigma certification. 

• Experience supporting HPAPI, API, or pharmaceutical manufacturing facilities. 

• Experience with automation, controls, and digital manufacturing technologies. 

• Core Competencies 

• Engineering Leadership 

• Strategic Planning 

• Capital Project Management 

• Facilities & Utility Systems Management 

• Reliability Engineering & Asset Management 

• GMP Compliance & Validation 

• Process Safety & Mechanical Integrity 

• Operational Excellence (Lean Six Sigma) 

• Root Cause Analysis & Problem Solving 

• Budget & Resource Management 

• Change Management 

• Cross-Functional Leadership 

• Communication & Influence 

• Contractor & Vendor Management 

• Regulatory Inspection & Customer Audit Support