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# CSV

- **Company:** Trinity Consultants - Advent Engineering
- **Location:** Worcester, MA, United States
- **Experience:** Experienced
- **Contract:** Permanent contract
- **Skills:** Microsoft Word, Microsoft Excel, Data Integrity, Microsoft PowerPoint
- **Published:** November 7, 2026
- **Apply:** https://www.juju.com/job/2_167793249

## About the Role

The successful candidate will work with a group of engineers involved in the design, automation, commissioning and start-up of various processes, systems and facilities. A combination of strong technical aptitude, automation engineering skills and technical writing are the desired skill set., * 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. xrbllit
 * A strong understanding of technical writing and presentation skills is required.

## Description

* 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