Validation Supervisor

Duties & 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.

Qualifications

• 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.