C

CAI

Operational readiness consulting for pharma

Computer Systems Validation Engineer

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeBoston, MA, USA$75k - $106k /yr

About the Job

Requirements

  • A bachelor's degree (BS/BA) in Computer Science, Engineering, or a related field is required, although equivalent experience may be accepted.
  • At least 3 years of experience in computer systems validation is required.
  • In-depth understanding of GAMP guidelines and FDA regulations, including 21 CFR Parts 11, 210, and 211, is required.
  • Familiarity with S88/S95 batch control standards is required.
  • Excellent oral and written communication skills in English are required.
  • Must be authorized to work in the United States without current or future sponsorship.
  • Ability to travel domestically and internationally as required.
  • Willingness to work paid overtime when needed.

Responsibilities

  • Author GxP computer validation documentation, including user requirements specifications, functional requirements specifications, requirements traceability matrices, and 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.
  • Support computer systems validation activities across manufacturing execution systems, distributed control systems, supervisory control and data acquisition systems, and batch systems.
  • Apply knowledge of GAMP and compliance expectations, including 21 CFR Parts 210, 211, and 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.
  • Support client engagements with a strong customer-service orientation.
  • Perform system assessments and remediation related to data integrity.
  • Collaborate with client teams to ensure validation compliance and delivery.

Desired Qualifications

  • Experience in biotech or pharmaceutical environments is preferred over medical device environments.
  • Experience with Rockwell platforms, DeltaV systems, and recipe authoring in batch environments is strongly preferred.
  • Experience with multiple automation and manufacturing execution systems is highly desirable.
  • Data integrity assessment and remediation experience is a plus.

About the Company

cb

CAI

Operational readiness consulting for pharma

CAI Technical Consulting Malaysia SDN (brand cagents.com) provides operational readiness consulting for pharmaceutical, biotech, and healthcare firms. It helps clients prepare for full-scale production through quick operational readiness assessments, gap-tailored plans, and hands-on implementation support in areas like project planning, production operations, asset management, reliability, and sustainability, plus Digital Pathology Validation for Leica Biosystems to meet regulatory standards. The firm differentiates itself by combining rapid assessments with practical, cost-effective strategies, ongoing industry collaboration, and global delivery that informs tailored solutions. Its goal is to help clients accelerate their path to compliant, scalable operations and successful production scale-up.

Company size
1,001-5,000
Company stage
Pre-seed
Total funding
$3.4M
Headquarters
Indianapolis, IN
Founded
1996

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