Warehouse Validation Engineer

Title: Warehouse Validation Engineer
Duration: 06 Months with possible extension ON-SITE
Location: Ridgefield Park, NJ 07660

POSITION DESCRIPTION:
Work Scope:
Detail oriented individual must be able to work alone and complete tasks without requiring much supervision. Must be able to meet deadlines and produce quality work consistently.
Engages in the day-to-day activities of the Validation function, ensuring the successful management of related activities and large projects. Supports Validation objectives, whilst adhering to regulatory compliance and achieving commercial success. This is a site-based position supporting the facility and will require gowning into the manufacturing and Warehouse suites. Bring equipment in/out of the cleanrooms as per procedure.
CQV experience is a must and good understand Commissioning, Qualification, and Validation protocols and final reports. Able to write final reports and technical deviations, if needed during CQV execution.
Ensures the Validation function supports operational needs and ensures regulatory compliance requirements are met.
Job Description:

Essential Functions of the job:

Develop and approve cGMP documents including, but not limited to: Equipment and instrument Qualification, Commissioning, Master Validation Plans, SOP's, Comparability reports, Aseptic Process simulation protocols and reports; process validation (PPQ), and cleaning/sterilization validation.
Lead validation activities for project activities including review of validation documentation and attendance at validation activities (FAT, SAT, IQ, OQ, PQ) etc.
Ensuring that the Validation department meets or improves key performance indicators (KPIs). Works to ensure all validation projects are on time and on budget. Ensures adequate validation resources. May manage validation consultants on a large project basis, as needed.
Leading and Managing projects for the validation of equipment, processes, and products to meet all safety, quality, regulatory and operational requirements.
Review of equipment specification/design/procurement/installation and validation. Participate in any hands on activities for commissioning of equipment.
Project planning and execution including scheduling, task management, milestone planning and reporting.
Generation, review, and approval of project documentation (User Requirement Specifications, validation protocols, reports) and Standard Operating Procedures
Lead validation activities for project activities including review of validation documentation and attendance at validation activities (FAT, IQ, OQ, PQ, etc.).
Employee will be required to work closely with both manufacturing, quality, warehouse and engineer associates.
Maintaining the validation sample management, assessing the requirements for data acquisition, and coordinating validation projects.
Ensuring appropriate investigation of validation discrepancies, errors, protocol failures, or validation testing errors requiring documented review and action to reconcile deviations.
Undertaking any other duties for any department within the business, which may be requested by the Line Manager, for which training and/or an explanation has been provided and understood.
Employment Type: Contractor
Salary: $ 55.00 Per Hour