Validation Manager

Overview Validation Manager role at WhiteCrow Research. Our client is a global injectables company headquartered in Bengaluru, India, expanding into new markets. The company focuses on sterile injectables that address gaps in healthcare delivery. As a Validation Manager, you will be responsible for leading validation activities, ensuring compliance with regulatory expectations, and maintaining the site's validation lifecycle program. Responsibilities Serve as the site Validation SME, overseeing all validation activities, including process, cleaning, equipment, utility, and computer system validation. Own and maintain the Validation Master Plan (VMP), ensuring alignment with regulatory expectations, site activities, and company objectives. Develop, implement, and maintain the site validation lifecycle program, including process validation, performance qualification (PQ), and CPV. Lead validation planning and coordination for new equipment, systems, and process changes with Engineering, Manufacturing, and Quality. Manage validation project timelines and resources to support commercial readiness and ongoing operations. Review and approve validation protocols, reports, and risk assessments in compliance with FDA, EMA, ICH Q8-Q10, EU Annex 15, and company standards. Participate in cross-functional risk assessments (e.g., FMEA) related to qualification and validation efforts. Ensure validation documentation is complete, accurate, and audit-ready. Provide guidance during regulatory inspections, audits, and customer assessments. Develop and maintain the site’s CPV program to monitor validated state and process performance over time. Define and monitor KPIs for validation program effectiveness and drive improvements in efficiency and compliance. Train and mentor staff on validation principles and procedures to build internal capability. Ensure change control, deviation management, and CAPA processes integrate with validation and qualification requirements. Qualifications / Experience Bachelor’s degree in engineering, Life Sciences, Pharmacy, or related discipline; Master’s preferred. Minimum 10-12 years of experience in pharmaceutical or biotechnology validation, with at least 3 years in a leadership or SME role. Validation of sterile injectable equipment expertise required. Strong knowledge of FDA cGMPs, ICH Q8–Q10, EU Annex 15, and validation best practices. Experience with sterile injectable manufacturing, aseptic processes, utilities, and equipment qualification. Experience with controlled substances and high-potency compounds preferred. Proven experience supporting regulatory inspections and third-party audits. Experience with commissioning, qualification, and validation in a startup (greenfield) or expansion environment preferred. Strong technical writing and documentation review skills. Ability to manage multiple projects and priorities in a fast-paced environment. Expertise in sterile systems, process validation, cleaning validation, and computer system validation. Excellent cross-functional communication, influencing, and collaboration skills. Strong analytical, risk-based decision-making, and problem-solving skills. Leadership presence with the ability to coach and mentor others in validation principles. Commitment to data integrity, patient safety, and product quality. Seniorities & Employment Seniority level: Mid-Senior level Employment type: Full-time Job function: Other Industry: Pharmaceutical Manufacturing Location: Perth Amboy, NJ and other locations; salary range posted as examples elsewhere on the page not applicable to this role. Referrals increase your chances of interviewing at WhiteCrow Research. Sign in to set job alerts for “Validation Manager” roles. #J-18808-Ljbffr