Job Description

About the Company- Top 10 Pharma company in India having Global business in Formulations, API and Biologics.
About the Role
We are seeking a senior engineering leader to oversee engineering operations for sterile formulations manufacturing. This role is critical in ensuring uninterrupted production, compliance with global standards, and continuous improvement of engineering systems. You will lead teams, manage infrastructure, and drive strategic projects that support the delivery of high-quality sterile products.
Key Responsibilities
Engineering Leadership
Lead engineering operations for sterile formulation site.
Ensure reliable performance of utilities, HVAC, cleanrooms, water systems (PW/WFI), and process equipment.
Oversee preventive, predictive, and corrective maintenance programs.
Compliance & Quality
Ensure adherence to USFDA, EMA, MHRA, and other regulatory requirements.
Maintain audit readiness and support inspections with complete documentation.
Drive data integrity and compliance across engineering systems.
Collaborate with global teams for standardization and best practices.
Ensure energy efficiency, sustainability, and cost optimization in engineering operations.
Team & Vendor Management
Lead and mentor engineering teams, fostering a culture of safety, accountability, and innovation.
Manage vendor relationships for AMC, spare parts, and technical services.
Drive training programs for engineering staff on sterile manufacturing requirements.
Strategic Contribution
Align engineering strategies with business goals and production targets.
Provide inputs for long-term capacity planning and risk management.
Champion digitalization, automation, and lean practices in engineering.
Qualifications
B.E./B.Tech in Mechanical, Electrical, Instrumentation.
15-20 years of experience in engineering leadership within sterile formulations manufacturing.
Strong expertise in sterile utilities, cleanroom operations, and aseptic equipment like Vial washing, Vial filling, autoclave, PFS, isolator, lyophillizer, tunnel etc.
Proven track record in handling audits, regulatory inspections, and large-scale projects.
Experience in handling multi product and atleast 12-15 sterile formulation lines on site will be suitable for this role.
Skills & Competencies
Strategic leadership and decision-making.
Deep technical knowledge of sterile manufacturing engineering systems.
Strong compliance orientation and documentation accuracy.
Excellent stakeholder management and communication skills.
Ability to drive innovation and continuous improvement.

Skills Required