CSV Engineer

CSV

Responsibilities:

• 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.
• Perform Data Integrity Assessments and review systems against 21 CFR Part 11
• Provide input on user and/or functional requirements of current and future processing equipment, and draft appropriate documentation. Additionally, interface with 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.
• Review DeltaV software and specifications to design test protocols.
• Comply with all regulatory, corporate, and Quality System policies

Qualifications:

• B.S. / M.S. in engineering or another relevant discipline.
• Minimum of 4+ years of experience working within an FDA regulated environment. Experience with upstream and downstream equipment is highly desirable.
• 2+ years' experience utilizing DeltaV. Capable of interacting with software and designing protocols for DeltaV software customizations.
• 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)
• Strong 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.