Validation Engineer

Validation Engineer

Job Description

The Validation Engineer ensures operational compliance with cGMP's and customer-required protocols during packaging processes. This role is responsible for facilitating and coordinating all activities of the Validation Department, ensuring continuous compliance with regulatory and company rules.

Responsibilities

• Develop and implement updates to the Master Validation Plan for the packaging facility alongside 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 and documents.
• 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 schedules with customers in collaboration with Business Operations, Scheduling, Engineering, and QA.
• Interact with Engineering, Technical Service, QA, Operations, Sales, and Business Ops to fulfill job responsibilities.
• Review change controls for equipment and validation impact.
• Review and approve calibration, qualification, and validation documentation for accuracy, completeness, and compliance.
• Assist in the preparation and execution of deviations, complaints, and non-conformance investigations.
• Assist with Annual Product Reviews.

Essential Skills

Additional Skills & Qualifications

Work Environment

This position requires working fully onsite five days a week. The work involves moving about the office and production floor, interacting with employees at all levels, and traveling for supplier audits and factory acceptance tests. The role necessitates staying stationary up to 80% of the time and lifting up to 25 pounds.

Pay and Benefits

The pay range for this position is $70,000.00 - $90,000.00 / yr.

Workplace Type

This is a fully onsite position in Wayne, NJ.

Application Deadline

This position is anticipated to close on May 23, 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.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Seniority level : Mid-Senior level

Employment type : Full-time

Job function : Quality Assurance

Industries : Business Consulting and Services

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