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Trinity Consultants - Advent Engineering · 3 weeks ago

CSV Engineer

Boston, MA

Full-time

Onsite

Mid Level

4+ years exp

Trinity Consultants - Advent Engineering is an engineering and consulting firm specializing in the pharmaceutical and biotechnology industries. They are seeking a CSV Engineer to draft and implement Quality System documentation, author protocols, and ensure compliance with regulatory standards while supporting technology transfer and continuous improvement efforts.

ConsultingInformation TechnologyLegal

Hiring Manager

Ana Bonilla

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

Qualification

DeltaVComputer Systems ValidationFDA regulated environmentQuality SystemsTechnical writingMicrosoft WordMicrosoft ExcelMicrosoft PowerPointCommunication skillsInterpersonal skillsTeamwork skills

Required

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