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Job Title: Packaging Engineer

Job Description

The Packaging 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

+ Background in packaging, ideally from a smaller company for diversified experience.

+ Aptitude in technical validation skills and operational communication/management.

+ Leadership skills and qualities.

+ Understanding of Quality Assurance and Validation technical skills.

+ Ability to serve as a liaison with internal QA and business operations.

+ Experience in documentation with reference to internal formats.

Additional Skills & Qualifications

+ Ability to work independently and as part of a team.

+ Exceptional communication (written and verbal) and interpersonal skills.

+ High level of multi-tasking ability and proven organizational skills.

+ Computer (PC), data collection, and analysis skills.

+ Comprehension of packaging equipment concepts for validation purposes.

+ Detail-oriented.

+ Minimum 3-4 years pharmaceutical/packaging experience or equivalent.

+ Proficiency in English, both written and verbal.

+ Proven abilities in the development, execution, and final review of IQ/OQ and PQ/PV validation protocols.

+ Experience in calibration, testing, and documentation requirements.

+ Ability to communicate effectively with customers regarding all aspects of validation and calibration.

+ Bachelor of Science Degree in Engineering required.

+ Ability to lead people and execute department objectives on time and on budget.

+ Physical ability to move about office areas and production floors, lift up to 25 pounds, and travel for audits.

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 $70000.00 - $90000.00/yr.

Will follow up with HR to receive these!

Workplace Type

This is a fully onsite position in Wayne,NJ.

Application Deadline

This position is anticipated to close on Jun 20, 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 [email protected] (%[email protected]) for other accommodation options.