Computer Systems Validation Engineer

Boston, Massachusettsfull timeOn Site

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mid

$75k–$106k

H1B: no

Cagents Computer Systems Validation Engineer responsible for authoring validation documentation and supporting CSV activities across multiple platforms in FDA-regulated industries. Ensures compliance with GAMP and 21 CFR regulations.

Responsibilities

Documentation & Compliance
Author GxP computer validation documentation (e.g., URS, FRS, RTM, summary reports)
Generate and execute test protocols and scripts
Ensure adherence to 21 CFR Part 11 and data integrity principles
Review and contribute to validation plans and risk assessments
System & Industry Expertise
Support CSV activities across various platforms including MES, DCS, SCADA, and batch systems
Engage with major systems and platforms such as Rockwell PharmaSuite, Rockwell Automation platforms, Emerson DeltaV, DeltaV Batch, Emerson Syncade, PI, GE, ABB, Siemens, Honeywell, PAS-X, FactoryTalk, FactoryLogix, PLM, Simatic, iFix, Wonderware
Apply knowledge of GAMP and compliance expectations (21 CFR Parts 210, 211, 11)
Utilize familiarity with S88/S95 batch control standards
Apply working knowledge of recipe authoring, batch recipe development, and S88-based recipe structures across systems such as DeltaV and Rockwell
Client Support & Technical Execution

Qualification

Experience with Rockwell platformsOther Requirements

Required

Bachelor’s degree (BS/BA) in Computer Science, Engineering, or related field; equivalent experience may be accepted
Minimum of 3+ years of experience in computer systems validation
Experience in biotech or pharmaceutical environments preferred over medical device
In-depth understanding of GAMP guidelines and FDA regulations (21 CFR 11, 210, 211)
Familiarity with S88/S95 batch control standards
Experience with Rockwell platforms, DeltaV systems, and recipe authoring in batch environments strongly preferred
Experience with multiple automation and manufacturing execution systems is highly desirable
Data integrity assessment/remediation experience is a plus
Other Requirements
Excellent oral and written communication skills in English
Ability to travel domestically and internationally as required
Willingness to work paid overtime when needed

Preferred

Experience in biotech or pharmaceutical environments preferred over medical device
Experience with Rockwell platforms, DeltaV systems, and recipe authoring in batch environments
Experience with multiple automation and manufacturing execution systems
Data integrity assessment/remediation experience