Lead Validation Engineer — Projects & Compliance

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.

Project Lead - Validation (Supervisor)

Full‑time, exempt/salary professional

Fall River, MA

General shift: 8:30 AM–5:00 PM (may vary based on business needs)

Site Engineering Manager

$76,000–$103,000

• 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.

• 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…