Validation Engineer, Remote- GC/ USC ONLY

Equipment Qualification (Validation) Engineer    

Remote

GC/ USC ONLY

Responsibilities:  

·         Draft and implement Quality System documentation designed to establish good validation practises within the organisation.  

·         Author URS, IQ, OQ and PQ protocols and execute them in compliance with GDP guidelines and internal quality standards.  

·         Design validation approaches, supported by appropriate statistical analyses, perform and/or coordinate all validation activities, analyse and assemble results, and draft validation reports.   

·         Provide input on user and/or functional requirements of current and future processing equipment, and draft appropriate documentation. Additionally, interface with Contract Manufacturers to ensure all relevant user and functional requirements are met.  

·         Provide support to non-engineering Staff, including those from R&D and Manufacturing, to ensure successful technology transfer and continuous improvement.  

·         Execute assigned duties on time and pro-actively telegraph delays and other issues to validation managers and other relevant stakeholders.  

·         Comply with all regulatory, corporate, and Quality System policies   

  

   

Qualifications:   

·         B.S. / M.S. in engineering or another relevant discipline.   

·         Minimum of 5+ years of experience working within a medical device environment or other FDA regulated environments. Experience with device-biologic combination products is highly desirable.  

·         Experience in the areas of Design Documentation (URS, FRS, DS, and other engineering specifications), Validation (IQ, OQ, PQ, PV, CSV, MVP, etc.), Quality Systems (Change Control, Non-Conformances, Requalification, etc.)  

·         Understanding of c.G.x.P principles and familiarisation with ISO 13485, ISO 14971, and 21C.F.R.820  

·         Working knowledge of Computer Systems Validation lifecycle and documentation.  

·         Proficient in Microsoft Word, Excel, PowerPoint.  

·         Must be able to work independently with adequate supervision, multi-task, and support several projects simultaneously.   

·         Must demonstrate strong communication, interpersonal and teamwork skills.  

·         A strong understanding of  technical writing and presentation skills is required. 

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