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. Whether at a single site or across multiple sites (cluster) 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 facilities (site or cluster).
- 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./ in Mechanical Electrical Instrumentation or Chemical Engineering.
- 15–20 years of experience in engineering leadership within sterile formulations manufacturing.
- Strong expertise in sterile utilities cleanroom operations and aseptic equipment.
- Proven track record in handling audits regulatory inspections and large-scale projects.
- Experience in multi-site (cluster) engineering management preferred for cluster head 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.
About the Company- Top 10 Pharma company in India having Global business in Formulations API and Biologics.About the RoleWe are seeking a senior engineering leader to oversee engineering operations for sterile formulations manufacturing. Whether at a single site or across multiple sites (cluster) th...
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. Whether at a single site or across multiple sites (cluster) 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 facilities (site or cluster).
- 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./ in Mechanical Electrical Instrumentation or Chemical Engineering.
- 15–20 years of experience in engineering leadership within sterile formulations manufacturing.
- Strong expertise in sterile utilities cleanroom operations and aseptic equipment.
- Proven track record in handling audits regulatory inspections and large-scale projects.
- Experience in multi-site (cluster) engineering management preferred for cluster head 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.
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