Planning, execution, reporting and tracking of facility Validation/Qualification projects. Validation/Qualification activities are inclusive of facility, equipment, software, cleaning, test method, and process validation. The position also supports design of experiment, feasibility, and commissioning activities with cross-functional collaboration to achieve project timeline and company targets.

Program Metrics & ObjectivesSupport the establishment, reporting, and achievement of performance metrics and objectives representative of an industry leading Validation Program.Training & MentorshipPursue opportunities develop further expertise on facility, equipment, software, cleaning, test method, and process validation. Train and mentor contractors and other Validation staff in areas of expertise, including peer review and/or approval of related documents.Project ManagementEnsure assigned projects are completed within approved timelines and budgets. Support the establishment of project priorities and effectively adapt to changes in direction based upon business needs. Maintain consistent communication with internal customers and stakeholders on changes in priority, status, and timeline.Validation PlanningDevelop and implement validation strategies, plans, and protocols for assigned projects, including new product development, new process development and improvements, product and process transfers, and base business compliance and change controls.ComplianceRemain up-to-date and ensure compliance with current industry trends as well as Quality Systems, IS013485, cGMP and other relevant regulatory protocols. Provide support for internal and external audits and Quality System investigations.Document ManagementCreate and revise SOPs supporting Validation Program functions and activities. Write documents and process through company systems.

- Develop and execute qualification and validation protocols and prepare subsequent reports per user requirements, policies and procedures and industry standards. - Assist in product transfers through preparation of required production documents. Provide input at development stage to ensure requirements for validation testing are considered in the design. - Provide input for the purchase of COTS equipment to ensure successful and compliant qualification and/or validation. - Work with contractors and internal personnel to ensure effective communication, interpretation and implementation of specifications. - Interact cooperatively to coordinate the implementation or scheduling of validation testing with affected departments and personnel.

- Perform testing of biological raw materials and finished goods; release acceptable product in compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations.- Bioburden: Water Systems & Environmental Monitoring. Aseptically collect and process samples requiring analysis. Perform microbial analysis of USP Purified water samples. Perform Environmental- Monitoring including viable and non-viable particulates of production air.- Handle diluent formulation development, optimization, and process development. Scientific review and specification of raw materials, preparation of Master Batch Records.- Development of product/process validation on existing products. Perform testing as required for validations and publish data accordingly. Document existing product/process validation test results and maintains validation test results (including electronic records).- Work alongside QC coordinators in order to maintain proper laboratory housekeeping; ensure optimal supply levels and equipment in the QC laboratory so that it is equipped to handle routinely scheduled testing and anticipated increases in test schedule.- File documentation of all test results and maintenance of product release records (including electronic records). Maintain product testing database and perform relevant statistical analyses associated with product specifications- Write and review documentation, including SOPs, reports and work instructions. Investigate deviations and write exception documents and OOS reports.- Supervise and provide guidance and direction to assigned technicians- Laboratory Techniques/ Equipment: Aseptic Transfer, Microbial Plating/Millipore Milliflex Pump System, Pipette, Centrifuge.