Site Engineering Head - API

Sun Pharmaceutical Industries, Inc.; India; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

Sun Pharmaceutical Industries, Inc. seeks a Site Engg. Head (API) with 15-20 years of API plant experience to lead engineering services, utilities and power at the Toansa site. The role focuses on reliable operations, project delivery within budget, and adherence to cGMP and FDA regulations.

Responsibilities include budgeting, CAPA closure, SOP review, risk assessment, energy conservation, and mentoring subordinates to uphold quality and compliance across maintenance and engineering activities.

Qualifications

• B.Tech in Mechanical Engineering
• 15-20 years of API plant experience with strong knowledge of cGMP and FDA regulations

Responsibilities

• Ensure optimum availability of engineering services including utilities and power
• Ensure projects are completed within time frames and approved budgets
• Prepare, monitor and control revenue and capex budgets
• Prepare power and fuel budgets and input for budgeting
• Ensure compliance to preventive maintenance and calibration schedules
• Investigate deviations related to Engineering and record conclusions
• Close CAPAs and CCRs related to engineering on time
• Perform SAP, TrackWise CAPA, LMS & DCM activities related to the role
• Review and approve SOPs as required
• Review risk analyses, risk assessment and risk re‑assessment
• Plan CAPA actions from investigations and regulatory observations
• Initiate and review energy conservation projects
• Liaise with government agencies for statutory requirements
• Maintain compliance with Quality, EHS policy and Code of Conduct
• Maintain timely maintenance of equipment and facilities
• Ensure availability of resources for engineering activities
• Review manpower productivity and training needs
• Ensure compliance with cGMPs and safety procedures

Education

B.Tech (Mechanical)

Job description

Site Engg. Head (API)

Senior Manager-1

Toansa

Key Responsibilities

• Ensure optimum availability of engineering services including Utilities & power.
• Ensure that all projects are completed within the given time frame and within the allocated resources/approved budget.
• Prepare, monitor and control revenue and capex budget.
• Prepare the power, fuel budget and provide input for budgeting process.
• Ensure compliance to preventive Maintenance & Calibration schedules.
• Investigate all deviations related to Engineering departments and record conclusions on time.
• Close CAPA's, CCR's related to engineering on time.
• Perform all SAP, Track wise CAPA, LMS & DCM activities relevant to the job role.
• Review & approve SOPs as per requirement.
• Review risk impact analysis, risk assessment & risk re-assessment.
• Plan & implement CAPA actions arising out of investigations, observations, risk assessments & regulatory observations.
• Initiate and review energy conservation activities and projects.
• Liaise with allied government agencies for statutory requirements.
• Ensure compliance to Quality, EHS Policy and Company's Code of Conduct.
• Maintain timely maintenance of equipment & facility and maintain records.
• Ensure availability of resources for all engineering department activities.
• Review manpower productivity on a regular basis.
• Training and development of subordinates and self-development.
• Ensure compliance to cGMPs, Safety procedures, current SOPs, statutory guidelines and company's code of conduct.
• Ensure availability of annual rate contracts to all engineering contractors.
• Ensure timely completion of billing cycle for every engineering vendor.

Job Requirements

Educational Qualification

B. Tech. (Mechanical)

Experience

15 - 20 Years in API Plant, Strong knowledge of cGMP, FDA regulations, and industry best practices

The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).