Validation Engineer Supervisor

Validation Engineer Supervisor

The Validation Engineer Supervisor assures operational compliance to cGMP's as well as required protocols during packaging processes. This role is responsible for facilitating and coordinating all activities of the Validation Department to ensure continuous compliance with regulatory and company rules.

Responsibilities :

• Develop and implement updates to the Master Validation Plan for the packaging facility in collaboration with Engineering Staff, QA Director / QA Manager, and Compliance Manager.
• Lead and coordinate activities for all associates in the department.
• Establish, document, and manage the Bioburden Monitoring, Compressed Air Point of Use, and Calibration programs.
• Develop and document change controls, validation plans, qualification protocols, and associated reports.
• Maintain and update a documented Cleaning Validation program.
• Maintain Validation Documentation / Control plan.
• Review and update Standard Operating Procedures applicable to this job function.
• Schedule, conduct, and document external audits.
• Coordinate all validation processes regarding validation programs and schedule with customers, in collaboration with Business Operations, Scheduling, Engineering, and QA.
• Interact with various departments such as Engineering, Technical Service, QA, Operations, Sales, and Business Ops to fulfill job responsibilities.
• Review change controls for equipment and assess validation impact.
• Review and approve calibration, qualification, and validation documentation for accuracy, completeness, and compliance.
• Assist in preparation and execution of Deviations, Complaints, and Non-conformance Investigations.
• Assist with Annual Product Reviews.

Essential Skills :

Additional Skills & Qualifications :

Work Environment :

The position is fully onsite, requiring attendance five days a week. The role involves moving about the office and production floor, communicating effectively with employees at all levels, and occasionally traveling for supplier audits and factory acceptance tests. The ability to stay stationary for up to 80% of the time and to lift and transport boxes or totes up to 25 pounds is required.

Job Type & Location :

This is a Permanent position based out of Wayne, New Jersey.

Pay and Benefits :

The pay range for this position is $70000.00 - $90000.00 / yr.

Workplace Type :

This is a fully onsite position in Wayne, NJ.

Application Deadline :

This position is anticipated to close on Nov 4, 2025.

About Actalent :

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.