Validation Engineer

Bull Valley, IL 60098

Posted: 08/28/2019 Industry: Biotech/R&D/Science Job Number: 49461

Brief Project Description: This resource will serve as a primary validation contact for Equipment (Aseptic and packaging), Clean Utilities, cleanroom and other related validation activities. Team Player to work with Engineering, New Product Development, Operations, and other functions with effective communication and problem solving.

Experience Requested: Strong validation background with prior equipment/ utilities/ facilities qualification experience, Experience in Sterility Assurance, Computer System, Process and Cleaning Validation preferred but not required.

Location/Travel: Expected to be physically present at the Woodstock facility on fulltime basis during normal business hours (8 am - 5 pm Monday-Friday). Off shift availability may be required depending on the needs for the project.

Reporting: This position will primarily report to Validation Department Designee. Primary Responsibilities:

Author Installation Qualification, Operation Qualification and Performance Qualification Protocols for the Aseptic and/or Packaging Equipment, Clean Utilities, Cleanrooms.

Execute validation deliverables and summarize results in report format.

Actively provide input and guidance in establishing new processes.

Hands on experience with aseptic and packaging equipment must.

Act as Subject Matter Expert when needed. Provide consultation and input to Change Controls and Documentation (SOPs, Training Documents, Batch Records, BOMs etc.) when needed Other responsibilities as assigned
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Familiarity with Blow-Fill-Seal Equipment, Process Tanks, Honeywell recorders etc.

Familiarity with Laser printers, Leak Detectors (Nikka, Wilco), Pouching Equipment (Doboy), Labelers, Line level serialization equipment, checkweighers, barcode scanners etc.

Sterility Assurance Validation, Process and Cleaning Validation experience preferred. Self Starter, Quick Learner Must Haves Technical aptitude and ability to work in fast pace environment with competing priorities Operate with minimum direction and supervision and be able to manage and track status of each activity Represent validation interests with other functions Identify and help implement solutions to the problems Strong GDP practices and legible handwriting On time task/ project completion Clear and precise communication

Example of Systems Utilities Water Pre-treatment RO/EDI System WFI System Clean steam Compressed gases

Aseptic Support Equipment BFS machines Isolators Chart recorders Tanks Homogenizers Autoclave Formulation Skids

Packaging Equipment Serialization Equipment Checkweighers Pouchers Deflashers Leak Detectors Printers Labelers Barcode Scanners Streamfeeders

Processes SIPs Cleaning Formulation, Purge and Filling Processes

Facilities Cleanrooms Warehouse Incubators Coolers Freezers

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