Actalent
Validation Engineer
The Validation Engineer ensures operational compliance with cGMPs and required protocols during packaging processes. This role is crucial in facilitating and coordinating all activities within 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 department associates. Establish, document, and manage Bioburden Monitoring, Compressed Air Point of Use, and Calibration programs. Develop and document change controls, validation plans, qualification protocols, 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 validation processes 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. Coordinate with all RL departments. Review change controls for equipment and 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. Review and update Standard Operating Procedures as needed. Assist with Annual Product Reviews. Essential Skills: Experience in packaging, preferably from a smaller company for diversified experience. Technical validation skills and operational communication/management abilities. Leadership skills and qualities. Understanding of Quality Assurance and Validation technical skills. Ability to act as a liaison with internal QA and business operations teams. Documentation completion with reference to internal formats. Additional Skills & Qualifications: Ability to work independently and as part of a team. Exceptional written and verbal communication and interpersonal skills. High level of multi-tasking ability and proven organizational skills. Computer skills for data collection and analysis. Comprehension of packaging equipment concepts for Validation purposes. Detail-oriented approach. Minimum 3 years of pharmaceutical experience or equivalent. Bachelor of Science Degree in Engineering required. Proven abilities in the development, execution, and final review of IQ/OQ and PQ/PV validation protocols. Experience in the development, execution, and final review of calibration, testing, and documentation requirements. Effective communication with customers regarding validation and calibration. Work Environment: This position is fully onsite, requiring attendance five days a week. The role requires the ability to lead and execute departmental objectives on time and within budget. The individual must move around office areas and the production floor, communicate effectively across all position levels, travel for supplier audits and factory acceptance tests, and remain stationary up to 80% of the time. Lifting and transporting boxes up to 25 pounds may be 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 Oct 6, 2025.
The Validation Engineer ensures operational compliance with cGMPs and required protocols during packaging processes. This role is crucial in facilitating and coordinating all activities within 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 department associates. Establish, document, and manage Bioburden Monitoring, Compressed Air Point of Use, and Calibration programs. Develop and document change controls, validation plans, qualification protocols, 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 validation processes 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. Coordinate with all RL departments. Review change controls for equipment and 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. Review and update Standard Operating Procedures as needed. Assist with Annual Product Reviews. Essential Skills: Experience in packaging, preferably from a smaller company for diversified experience. Technical validation skills and operational communication/management abilities. Leadership skills and qualities. Understanding of Quality Assurance and Validation technical skills. Ability to act as a liaison with internal QA and business operations teams. Documentation completion with reference to internal formats. Additional Skills & Qualifications: Ability to work independently and as part of a team. Exceptional written and verbal communication and interpersonal skills. High level of multi-tasking ability and proven organizational skills. Computer skills for data collection and analysis. Comprehension of packaging equipment concepts for Validation purposes. Detail-oriented approach. Minimum 3 years of pharmaceutical experience or equivalent. Bachelor of Science Degree in Engineering required. Proven abilities in the development, execution, and final review of IQ/OQ and PQ/PV validation protocols. Experience in the development, execution, and final review of calibration, testing, and documentation requirements. Effective communication with customers regarding validation and calibration. Work Environment: This position is fully onsite, requiring attendance five days a week. The role requires the ability to lead and execute departmental objectives on time and within budget. The individual must move around office areas and the production floor, communicate effectively across all position levels, travel for supplier audits and factory acceptance tests, and remain stationary up to 80% of the time. Lifting and transporting boxes up to 25 pounds may be 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 Oct 6, 2025.