Project Lead - Validation (Supervisor)

· Cipla•Fall River, MA

2d•$76,000 - $103,000•Onsite

About The Position

NOTICE: The posting for local applicants only - is not for those applying for a global assignment and/or for employees working outside of Cipla's U.S. Subsidiaries or Affiliates. Job Title : Project Lead - Validation (Supervisor) FLSA Classification : Full-Time, Exempt/Salary Professional Work Location : Fall River, MA Work Hours: General Shift: 8:30AM – 5:00PM (May very 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 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. 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. To raise the change controls, whenever required changes are to be made to facilities and equipment. Co-ordinate with other departments such as Civil, Mechanical, Admin, Quality Assurance, Production etc. for various day-to-day activities. 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.

Requirements

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.
Excellent communication, leadership, and problem-solving skills.

Nice To Haves

PMP certification is a plus.
Experience with audit preparation, financial oversight, and CapEx processes.

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.
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.
To raise the change controls, whenever required changes are to be made to facilities and equipment.
Co-ordinate with other departments such as Civil, Mechanical, Admin, Quality Assurance, Production etc. for various day-to-day activities.
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.