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

• Background in packaging, ideally from a smaller company for diversified experience.
• Aptitude in technical validation skills and operational communication/management.
• Leadership skills, with potential mentoring for career progression.
• Understanding of Quality Assurance and Validation technical skills.
• Ability to act as a liaison between internal QA and business operations teams.
• Proficiency in documentation with internal formats.
• Minimum 10 years of pharmaceutical experience or equivalent.
• Bachelor of Science Degree in Engineering.

Additional Skills & Qualifications

• Supervisory experience required.
• Ability to work independently and as part of a team.
• Exceptional communication (written and verbal) and interpersonal skills.
• High-level multi-tasking ability with proven organizational skills.
• Computer, data collection, and analysis skills.
• Comprehension of packaging equipment concepts for Validation purposes.
• Detail-oriented.
• Proven abilities in development, execution, and review of IQ/OQ and PQ/PV validation protocols.
• Experience in calibration, testing, and documentation with contracted providers and internal staff.

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.