- Draft and implement Quality System documentation designed to establish good validation practices within the organization.
- 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, 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 pro-actively telegraph delays and other issues to validation manager and other relevant stakeholders.
- Comply with all regulatory, corporate, and Quality System policies
- 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 familiarization 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.