Senior CQV Validation Lead - Aseptic Systems & Compliance

Catapult; Princeton (FL); On-site; USD 120,000 - 180,000; Full time

Job summary

Erytech in Princeton, NJ, seeks a Senior Validation Manager to lead the site validation program, covering facility, equipment, laboratory instruments, and computerized systems in an aseptic environment.

You will define, implement, and maintain the validation program, ensuring compliance with FDA, ICH, ISO, and cGMP standards while collaborating with Engineering and Quality teams on multiple projects.

Qualifications

• Bachelor's degree in Engineering, Science, or related technical field.
• Minimum 10 years CQV in a cGMP manufacturing environment and aseptic processes.
• Expert in Quality Risk Management and risk-based test strategy development.
• Familiar with ISPE/PDA guidelines and FDA/ICH/ISO/cGMP requirements.

Responsibilities

• Lead validation activities in a hands-on, cross-functional setting with engineering and Quality teams.
• Develop and maintain validation master plans and risk-based test strategies.
• Prepare, review and coordinate URS, risk assessments, and validation documentation.
• Oversee periodic system reviews and requalification activities.
• Investigate deviations and assess impact on validated status for new or changed systems.
• Represent site during inspections and audits; address regulatory observations when required.

Skills

Quality Risk Management

cGMP manufacturing

Validation planning

Documentation writing

Team collaboration

Education

Bachelor's degree in Engineering, Science, or related technical field

Tools

Kaye Validator

Statistical tools

Job description

Erytech in Princeton, NJ, seeks a Senior Validation Manager to lead the site validation program, covering facility, equipment, laboratory instruments, and computerized systems in an aseptic environment.

You will define, implement, and maintain the validation program, ensuring compliance with FDA, ICH, ISO, and cGMP standards while collaborating with Engineering and Quality teams on multiple projects.