Lead Validation Manager – Sterile Injectables

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

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.