Job Description :
Job Title : Validation Engineer
Location : Providence, RI
Duration : Contract


Position Description:

Draft and implement Quality System documentation designed to establish good validation practices within the Organization.
Design validation approaches, supported by appropriate statistical analyses, draft validation protocols, perform and/or coordinate all validation activities, analyze 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 within budget; pro-actively telegraph delays and other issues to relevant stakeholders.
Comply with all regulatory, corporate, and Quality System policies
Complete other projects and/or assignments as required.

Required Skills:

B.S. / M.S. in engineering or another relevant discipline.
Minimum of 5+ years of experience working within a medical device environment. 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 familiarization with ISO 13485, ISO 14971, and 21C.F.R.820
A strong understanding of statistical analyses is required, as are strong technical writing and presentation skills.
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 interpersonal and teamwork skills.
A strong understanding of statistical principles is required, as are strong technical writing and presentation skills.