Associate Director Engineering

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.