Site Engineering Head () Sterile Formulations
Share
Job Location:
Monthly Salary:
Posted on:
2 hours ago
Vacancies:
1 Vacancy
Job Summary
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./ 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.
Required Skills:
Engineering Maintenance Vial ampoule Lyophillizer sterile injectable parenteral
Key Skills
- Presentation Skills
- Risk Management
- Financial Services
- IFRS
- Banking
- Pricing
- Analysis Skills
- Securities Law
- Investment Banking
- Relationship Management
- Strategic Planning
- Leadership Experience
