Our Biopharmaceutical Client is seeking a Facilities and Equipment Systems Specialist to join their team in West Point, PA. This individual will ensure effective, timely CAPAs are provided in response to internal audits, regulatory inspections, customer audits, and Divisional audits. They will participate in equipment installation and qualifications, documentation generation as well as establishment of inventory and applicable SOPs, inventory of lab computer systems. They will perform supporting activities for management of analytical instrumentation and compliance oversight, as well as support archive of calibration documents. They will assist in SOP and deviation writing, and make sure the site is Permanent Inspection Read. This individual will design and develop automated workflows using Microsoft Power Automate to stream line processes and create custom applications with Microsoft Power Apps to meet specific business needs to enhance user experience.
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- Technical knowledge with qualification, and computer system validation within a GxP environment
- GMP work experience
- Bachelor's Degree in related field
- 1+ years of industry experience
Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.