About the Role The position will be accountable for managing utility systems in injectable facilities, ensuring seamless operations, regulatory and statutory compliance, and efficient facility management practices. Responsibilities Project Leadership: Lead end-to-end execution of greenfield/brownfield injectable facility projects, including design, budgeting, procurement, construction, commissioning, and qualification. Utilities Oversight: Ensure uninterrupted and compliant operation of critical utilities—WFI, Pure Steam, RODI, HVAC, Compressed Air, Nitrogen, and chilled water systems. Regulatory Compliance: Ensure all systems and documentation meet cGMP, GEP, and regulatory standards (USFDA, EU-GMP, WHO-GMP). Prepare for and support audits and inspections. Cross-Functional Collaboration: Work closely with QA, Production, Validation, and EHS teams to align project deliverables with operational and compliance needs. Vendor & Contractor Management: Evaluate and manage third-party vendors, consultants, and contractors to ensure timely and quality project execution. Sustainability & Energy Efficiency: Drive initiatives for energy optimization, water conservation, and sustainable engineering practices. Team Development: Mentor and lead a team of project engineers and utility specialists. Foster a culture of accountability, safety, and continuous improvement. Qualifications Bachelor’s or Master’s degree in engineering (Mechanical/Electrical/Chemical/Instrumentation) from a recognized institution Required Skills In-depth knowledge of critical utility systems : WFI, RODI, HVAC, Pure Steam, Compressed Air, Nitrogen, and chilled water systems Strong understanding of cGMP, GEP, and USFDA regulatory guidelines Competence in project budgeting, vendor evaluation, and contract management Expertise in commissioning, qualification (DQ/IQ/OQ/PQ) Proficient in engineering documentation, risk assessments, and audit readiness Excellent interpersonal and leadership skills to manage cross-functional teams Preferred Skills Experience with automation systems , BMS, and SCADA Exposure to sustainability programs and energy conservation initiatives Hands-on experience with engineering tools and design software (AutoCAD, MS Project, etc.) Knowledge of lean engineering and continuous improvement methodologies We are an equal opportunity employer committed to creating an inclusive workplace where diversity is valued and respected. We welcome applications from individuals of all backgrounds and experiences, regardless of race, gender, age, disability, religion, or sexual orientation.
Job Title
Associate Director Engineering