Computer System Validation Manager Jobs in Somerset, MA

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.
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
GLOBAL COMPANY
Cipla is a leading global pharmaceutical company, dedicated to high-quality, branded and generic medicines. We are trusted by healthcare professionals and patients across geographies. Over the last eight decades, we have strengthened our leadership in India's pharmaceutical industry and fortified our promise of strengthening our global focus by consolidating and deepening our presence in the key markets of India, South Africa, the U.S., and other economies of the emerging world.
Cipla employs handpicked professionals not just for their knowledge and experience but for their zeal to make a difference to the world of healthcare. The company believes that our biggest assets are the employees who lead us to prosperity and growth in the future. Driven by the vision, none shall be denied, Cipla's focus has always been on making affordable, world-class medicines with a reputation for uncompromising quality standards across the world.
CIPLA NEW YORK (INVAGEN PHARMACEUTICALS, INC.)
About InvaGen Pharmaceuticals, a Cipla subsidiary InvaGen Pharmaceuticals, Inc. is engaged in the development, manufacture, marketing, and distribution of generic prescription medicines with focus on a range of therapeutic areas, including cardiovascular, anti-infective, CNS, anti-inflammatory, anti-diabetic, and anti-depressants. The company was founded in 2003 and is based in Central Islip and Hauppauge, New York. As of February 18, 2016, InvaGen Pharmaceuticals, Inc. operates as a subsidiary of Cipla (EU) Limited.
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.