Validation Engineer in West Point, PA at JLL

Date Posted: 4/30/2018

Job Snapshot

Job Description

We are currently seeking a Validation Engineer to be responsible for conducting and delivering analytical and engineering studies to support cleaning validation, cleaning verification, thermal sterilization, thermal sanitization, and controlled temperature unit mapping for major GMP clinical and commercial equipment and facilities. 

Write, approve, execute, and close-out validation reports. 

Maintain GMP status of assigned suite areas and facilities.  

Responsible for project management to set and meet lead times for cleaning and sterile validation testing, elevate need for additional resources, and ensure equipment periodic revalidations stay on schedule. 

This position is on a client account within the pharmaceutical industry. 

Responsibilities:

Responsible for periodic revalidation of major process equipment in Clinical Pilot Plants and in Commercial Facilities.

Conduct field cleaning validation testing including performance of visual inspection, and the collection of rinse water samples, swab samples, and/or extraction samples.  Equipment will include: bioreactors, fixed tanks, transfer lines, chromatography skids, filtration skids, portable vessels, centrifuges, homogenizers, ultrasonic washers, glasswashers, lyophilizers, vial washers, chromatography columns, filter carts, and filter housings.

Conduct thermal validation testing using thermocouple sensors and data collection instruments on equipment including GMP autoclaves, decon autoclaves, waste inactivation systems, dry heat ovens, lyo cabinets, bioreactors, holding tanks, portable tanks, transfer lines, and controlled temperature units (CTUs).

All work includes protocol write-up, sampling plan generation, scheduling, Lock Out/ Tag Out, testing, report write-up, review, approval, and closeout.  

Lock Out/ Tag Out participation is to ensure zero energy of equipment and permit safely breaking into lines for testing.

Practice highest regard for Safety:  Work with potentially dangerous systems, some which utilize high pressures and temperatures.  Perform validation review and support for pilot plant campaign and master cell bank readiness plans.

Act as Subject Matter Expert (SME) on periodic re-validation of commercial product equipment and manufacturing. 

Possess ability to answer validation questions and interact with various regulatory agencies. 

Act as validation reviewer for operation's SOP's with validation cycle parameters and possess ability to quickly address operations’ issues with equipment validated cycles.

B.S. / B.A. in Engineering or Science.

1 to 3 years relevant experience in pharmaceutical validation testing discipline.

Strong interpersonal skills and problem solving ability.

Demonstrated leadership and teamwork skills, excellent analytical abilities, excellent written and verbal communication skills.

Proven record of providing excellent internal and external customer service.

Weekend and off shift work required as needed.


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