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

equal opportunity employer