Job Type
Full-time
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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