Associate Manager, Validation

Job summary

The role involves leading a team of validation professionals in a regulated biopharma manufacturing setting, focusing on team development, resource allocation, and ensuring compliance with validation standards.

Qualifications

• Bachelor’s or Master’s degree in engineering, life sciences, or a related field.
• Over 6 years of experience in validation/CQV within GMP biopharma or pharma, including protocol/report authorship and execution.
• At least 2 years of experience in mentoring or leading teams, with direct people management experience preferred.
• Familiarity with regulatory inspections, investigations, and change management.

Responsibilities

• Lead, coach, and develop a diverse validation team; delegate responsibilities and provide technical mentorship.
• Plan and oversee validation lifecycle activities including commissioning and qualification (CQV) and cleaning validation.
• Manage validation schedules and ensure timely delivery of protocols and reports.
• Handle deviations, investigations, CAPAs, and change controls in collaboration with QA and other departments.
• Standardize templates and tools for validation processes.
• Prepare documentation for regulatory inspections and represent Validation in cross-functional forums.
• Track KPIs and drive continuous improvement initiatives.

Skills

• Strong understanding of validation lifecycle and risk-based approaches (e.g., ASTM E2500, GAMP 5).
• Excellent prioritization, stakeholder management, and technical communication skills.
• Analytical and detail-oriented, with a commitment to safety and quality.

Education

• Bachelor’s or Master’s degree in engineering, life sciences, or a related field.

Tools

• Familiarity with quality systems, document control, and CMMS/EMS/BMS/SCADA is a plus.