Validation Engineer
3 weeks ago
Description
Key Duties & Responsibilities
Draft and implement Quality System documentation including SOPs and Traceability Matrix 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.
Coordinate all validation activities with vendors, 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.
Requirements
Knowledge and Skills:
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 guidelines.
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.
Educations and Experience:
Degree in engineering / Pharmaceuticals or another relevant discipline.
Minimum of 4+ years (BS) or 2+ years (MS) of experience working within a medical device environment or other FDA regulated environments.
Experience with Biological products is highly desirable.
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