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Arcadis · 2 weeks ago

Computer Systems Validation Engineer

Worcester, MA

Full-time

Onsite

Entry Level

1+ years exp

Arcadis is the world's leading company delivering sustainable design, engineering, and consultancy solutions for natural and built assets. They are seeking a Computer Systems Validation Engineer to support validation activities in the Biotech and pharmaceuticals sector, ensuring compliance with industry regulations and best practices.

Civil EngineeringConsultingWater

Culture & Values

No H1B

Hiring Manager

Natalie Hebert

Responsibilities

Provide technical support for ensuring that current versions of the Computer System are qualified through verification and maintained in a qualified state

Accurately record data and performing statistical analysis where applicable during execution

Adhere to company procedures and government regulations such as Good Documentation Practices (GDP), GAMP and 21 CFR part 11 when executing protocols

Document deviations and non-conformances that occur as a result of the qualification

Collaborate with Management, Developers, Implementation, business development and client representatives to meet deliverable(s)

Route, Approve, Develop and Revise Requirement Specifications, Test Scripts, Validation Master Plans, supporting documentation for validation, admin manuals and software documentation where applicable

Coordinate with reviewers and approve to finalize documentation

Perform a review of quality systems and manufacturing data, summarize and draw conclusions to be included in individual product assessments

Execute Qualification Protocols

Track and communicate progress of deliverable(s)

Communicate complications or issues in the validation process

Other duties as assigned