Validation Manager

WhiteCrow Research; Branchburg Township (NJ); On-site; USD 100,000 - 130,000; Full time

Job summary

A global injectables company is seeking a Validation Manager in New Jersey to lead validation activities, ensure compliance with regulatory expectations, and manage the validation lifecycle program. Candidates should have a Bachelor's degree in engineering or related fields, with 10-12 years of experience in pharmaceutical validation. The role includes responsibilities for managing projects, documentation, and staff training.

Qualifications

• Minimum 10-12 years of experience in pharmaceutical or biotechnology validation.
• At least 3 years in a leadership or SME role.
• Validation of sterile injectable equipment expertise required.

Responsibilities

• Oversee all validation activities including process and equipment validation.
• Maintain the Validation Master Plan to align with regulatory expectations.
• Develop and implement the site validation lifecycle program.

Skills

Leadership presence

Technical writing

Analytical skills

Communication skills

Risk-based decision-making

Aseptic processes

Education

Bachelor’s degree in engineering, Life Sciences, or Pharmacy

Master’s degree

Job description

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.

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