Mechanical Supervisor

Job Title:Project Lead - Mechanical (Supervisor)

FLSA Classification: Professional, Exempt

Work Location: Fall River, MA

Work Hours: General: 8:30am - 5:00pm (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 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.

• Coordinate validation activities for mechanical systems including IQ/OQ/PQ documentation and execution.

• 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.

Working conditions:

This role works in a cGMP office environment. However, this role will frequently be present in a laboratory and manufacturing environment, where personal protective equipment may be required, which may include 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 than an 8-hour period.

• Usage of appropriate personal protective equipment when required