Project Lead - Mechanical (Supervisor)

About the role

The Project Lead - Mechanical (Supervisor) position is open exclusively to local applicants. Applicants must not apply for a global assignment or for roles outside of Cipla's U.S. subsidiaries or affiliates.

Duties And Responsibilities

• Design, review and approve protocols for equipment and processes to produce pharmaceutical drug products meeting internal, external and regulatory guidelines.
• Maintain facility as per cGMP and regulatory requirement.
• Introduce new SOP’s, equipment and instruments to improve the work environment by safety and quality point of view by working closely with Quality Assurance team.
• Compile and maintain records of validation documentation and electrical schematics, installed equipment, installation or operational problems, corrective, and preventive actions.
• Review the Design, Installation, Operational and Product qualification of operations machinery.
• Project planning, design, monitoring and project execution.
• Co-ordination with project contractor for procurement and installation for projects work.
• Preparation of revised Layouts whenever modification system is done for plant or facility.
• Modification / Changes of machine/process of facility as per requirement.
• To raise the change controls, whenever required changes are to be made to facilities and equipment.
• Co-ordinate with other departments such as Mechanical, Site Services, Quality Assurance, Production etc. for various day-to-day activities.
• Lead mechanical engineering projects from concept through completion, including planning, execution, and close-out.
• Develop and manage detailed project plans, schedules, budgets, and resource allocations.
• Track project milestones and deliverables, ensuring timely and cost-effective execution.
• Provide technical expertise for mechanical equipment selection, installation, and optimization.
• Oversee HVAC, cleanroom systems, compressed air, chilled water, steam, and other utility systems.
• Ensure mechanical designs and installations comply with cGMP, FDA, and other regulatory standards.
• Collaborate with Validation and Quality teams to ensure mechanical systems meet performance and compliance requirements.
• Support change control and risk assessments related to mechanical installations.
• Prepare and maintain documentation to support internal and external audits.
• Ensure mechanical engineering activities align with quality and regulatory requirements.
• Collaborate with Quality teams to address audit findings and implement corrective actions.
• Work with Finance and Procurement teams to manage project budgets and capital expenditures.
• Review and approve vendor quotes, purchase orders, and invoices.
• Monitor financial performance and report variances to management.
• Prepare and submit Capital Expenditure (CapEx) requests with detailed scope, and justification.
• Track approval status and ensure alignment with corporate financial planning.
• Support CapEx forecasting and reporting for mechanical engineering initiatives.
• Ensure accurate and timely data entry and reporting within SAP modules relevant to mechanical engineering and finance.
• Partner with Manufacturing, Quality Assurance, Validation, Regulatory Affairs, and external vendors.
• Facilitate effective communication and coordination across departments.
• Identify potential risks and implement mitigation strategies.
• Ensure mechanical projects meet quality, safety, and environmental standards.
• Implementation of various projects pre-requirement.
• To maintain the safety norms as per the Health Safety & Environment guidelines.
• To monitor project activity for the in Unit IV, Scheduling, monitoring and keeping track on CAPEX project activities.
• Detailing with respect to design, manufacture of tooling and methods, supervision of large onsite project.
• Work closely with external electrical/instrumentation service agencies on upgrading existing systems and troubleshoot errors and breakdowns.
• Ensure all process improvement projects are completed on time and within budget.
• Diagnose, test and analyze the performance of electrical components, assemblies, or systems.
• Troubleshoot the existing systems for any issues which hampers the operations in any manner.
• Ensure that the plant is maintained at all Time for audit readiness.
• Perform any other Job or responsibilities assigned by the reporting manager. Any other job allocated by Department Head.

Education And Experience

• Bachelor’s degree in Engineering (Mechanical, Electrical, or related field); Master’s preferred.
• Minimum 5 years of experience in pharmaceutical or biotech engineering and validation project management.
• Strong knowledge of sterile manufacturing processes (vials, PFS, IV bags).
• Experience with validation lifecycle documentation and execution.
• Familiarity with project management tools (e.g., MS Project, Primavera).
• Experience with SAP systems for engineering and financial operations.
• PMP certification is a plus.
• Experience with audit preparation, financial oversight, and CapEx processes.
• Excellent communication, leadership, and problem-solving skills.