The Validation Engineer/Manager reports to the VP, Quality Systems & Regulatory Affairs and is responsible for providing comprehensive support for production quality and continuous improvement initiatives and leading equipment/facility commissioning, installation and performance qualifications, and process/product validations. He/she will have overall responsibility for Unilife"s Master Validation program and will be responsible for & SIXFIGURE
Minimum Required Skills:Engineering Technician, Product Development, Medical, Pharmaceutical, FDA, GMP, LEAN, MS ProjectProduct Development TechnicianDirect Hire/PermHarrisburg, PA We are currently...? Experience in medical device or pharmaceutical manufacturing requirements (i.e. FDA. GMP, ISO) of class DICE
testing ensuring FDA and other regulatory compliance Develop and execute software validation... applicable electronic systems, including hardware, software, networks, etc. meet all FDA other regulatory...) and database Experience with electronic document management systems in FDA regulated medical device JOBCIRCLE