Validation Supervisor

Notice: The posting is for local applicants only and is not for those applying for a global assignment or for employees working outside of Cipla's U.S. subsidiaries or affiliates. Job Title Project Lead - Validation (Supervisor) Classification Full‑time, exempt/salary professional Location Fall River, MA Work Hours General shift: 8:30 AM–5:00 PM (may vary based on business needs) Reports to Site Engineering Manager Salary Range $76,000–$103,000 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 requirements; introduce new SOPs, equipment and instruments to improve safety and quality in collaboration with the Quality Assurance team. Compile and maintain records of validation documentation, electrical schematics, installed equipment, and issues related to corrective and preventive actions. Review the Design, Installation, Operational and Product qualification of operating machinery. Plan, design, monitor and execute projects; coordinate with project contractors for procurement and installation. Prepare revised layouts when system modifications are made for the plant or facility. Implement modifications or changes to machines/processes as required. Lead engineering and validation 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 engineering expertise for equipment design, facility upgrades, and process improvements. Lead validation efforts, including preparation and execution of protocols (IQ/OQ/PQ), risk assessments, and change controls. Ensure all engineering and validation work complies with cGMP, FDA, and other regulatory standards. Prepare and maintain documentation to support internal and external audits. Ensure engineering and validation activities align with quality and regulatory requirements. Collaborate with Quality and Compliance 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. Track approval status and ensure alignment with corporate financial planning. 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 projects meet quality, safety, and environmental standards. Raise change controls when required changes are made to facilities and equipment. Coordinate with other departments such as Civil, Mechanical, Admin, Quality Assurance, Production, etc. for day‑to‑day activities. Implement pre‑requisite projects. Maintain safety norms as per Health Safety & Environment guidelines. Monitor project activity for CAPEX projects, detailing design, manufacture of tooling and methods, and supervision of large on‑site projects. 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 existing systems for any issues that hamper operations. Ensure that the plant is maintained at all times for audit readiness. Perform any other job or responsibilities assigned by the reporting manager. Any other job allocated by the 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 such as MS Project or 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. Working Conditions This role works in a cGMP office environment but will frequently be present in a laboratory and manufacturing environment. Personal protective equipment may be required, including uniforms, lab coats, safety glasses, respiratory protection, hearing protection, etc. Work with or around solvents, powders, or other materials commonly found in a pharmaceutical laboratory or manufacturing facility may be required. Physical Requirements Unassisted lifting up to 10 kg may be required. Standing/walking for 80 % or greater of an 8‑hour period. Use of appropriate personal protective equipment when required. EEO Statement Cipla is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, sex, sexual orientation, gender identity, religion, national origin, genetic information, disability, or protected veteran status. #J-18808-Ljbffr Merck & Co.