R&D Validation Lead – Equipment Qualification

The Validation Lead – Equipment Qualification will be responsible for planning, Execution and overseeing validation activities related to equipment, instruments, scientific applications and systems used in pharmaceutical R&D operations. The role requires strong knowledge of regulatory guidelines, qualification practices, and documentation standards to ensure compliance with global quality requirements. The candidate will lead the validation team, coordinate with cross-functional stakeholders, and ensure timely completion of all qualification and validation deliverables.

Key Responsibilities :

• Lead the equipment qualification and validation team within the R&D operations.
• Develop and review validation master plans (VMP), user requirement specifications (URS), risk assessments, and validation protocols (IQ/OQ/PQ).
• Oversee qualification of new equipment, instruments, utilities, and lab systems as per regulatory and internal requirements.
• Ensure compliance with cGMP, GAMP 5, FDA, EU, and other applicable regulatory guidelines.
• Review and approve all validation documents including reports, traceability matrices, and deviation records.
• Coordinate with Instrumentation & engineering, QA, R&D, and external vendors for smooth execution of qualification activities.
• Lead investigations and change controls related to equipment and systems.
• Train and guide team members on validation practices and documentation standards.
• Maintain validation status records and ensure periodic requalification as required.
• Provide validation support for eLN enhancement and R&D digitization projects, including QMS, CC, RA, CIA, and the creation and execution of scripts.
• Support regulatory audits and ensure readiness of documentation and processes.
• An added advantage would be having technical expertise in reviewing HPLC/UPLC/ mass spec and all analytical instruments calibration documents.

Required Qualifications & Experience :

• Bachelor’s or master’s degree in engineering or related field.
• 13–14 years of experience in equipment qualification, validation, or related quality functions in the pharmaceutical or biopharmaceutical industry.
• Strong hands-on experience in IQ/OQ/PQ execution, protocol preparation, and validation lifecycle management.
• Good understanding of GMP, GLP, GAMP 5, risk-based validation principles, and data integrity guidelines.
• Experience managing or leading a validation/qualification team.
• Familiarity with qualification of analytical instruments, process equipment, and computerized systems.
• Strong documentation, problem-solving, and communication skills.
• Ability to work cross-functionally and manage multiple validation projects simultaneously.

We are an Equal Opportunity Employer and welcome applicants of all backgrounds. All qualified candidates will receive consideration without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, disability, or veteran status.