Katalyst CRO

CSV Engineer

Katalyst CRO, Boston

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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.

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.

Requirements

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.

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