Compliance Engineer / CSV Engineer

Atlas

$90K — $130K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in Engineering, Computer Science, Information Systems, Life Sciences, or related field.
  • Experience with IT compliance and computer system validation in the pharmaceutical or life sciences sector.
  • Strong knowledge of CSV, GxP, and validation documentation standards.
  • Hands-on experience executing validation testing and preparing documentation.
  • Proven ability to document non-conformances and compliance gaps effectively.
  • Keen attention to detail for producing audit-ready documentation.
  • Excellent communication and problem-solving abilities.

Responsibilities

  • Perform validation activities for IT compliance and computer systems in a life sciences environment.
  • Support the creation of validation deliverables, including test protocols and summary reports.
  • Execute testing to ensure systems meet quality and regulatory requirements.
  • Identify and document compliance gaps, deviations, and non-conformances.
  • Ensure all documentation adheres to compliance standards and workflows.
  • Collaborate with IT and business teams to clarify validation needs and expectations.
  • Review system changes to assess their impact on validation processes.

Benefits

  • Opportunity to work on high-impact global pharmaceutical initiatives.
  • Chance to join a fast-growing management consulting firm with a prestigious client base.
  • Work within a team of experts in a dynamic consulting environment.
  • Engagement with leading life sciences companies, many of which are Fortune 100.
Full Job Description
What You Will Do
We are seeking an experienced Compliance Engineer Consultant to support IT compliance and computer system validation activities for a global life sciences client. This role requires hands-on engineering experience executing validation work, supporting compliance documentation, and ensuring computer systems meet applicable quality, regulatory, and documentation standards. The ideal consultant will have experience working in a pharmaceutical compliance environment and will be comfortable performing ground-level execution work while partnering with IT, Quality, Compliance, and business stakeholders.

Job Responsibilities

* Perform computer system validation and IT compliance execution activities for regulated systems in a life sciences environment.
* Support validation deliverables including requirements, risk assessments, test protocols, test scripts, traceability matrices, deviation documentation, and validation summary reports.
* Execute testing and validation activities to confirm systems meet business, technical, quality, and regulatory requirements.
* Identify, document, and support resolution of non-conformances, deviations, compliance gaps, and documentation issues.
* Ensure documentation follows established compliance standards, templates, procedures, and approval workflows.
* Partner with IT, Quality, Compliance, business, and technical teams to understand system functionality, validation needs, and documentation expectations.
* Support review of system changes, enhancements, and releases to assess validation impact and required compliance activities.
* Maintain clear, accurate, audit-ready documentation aligned with applicable GxP, CSV, and quality standards.
* Provide hands-on engineering support for validation execution rather than only managing requirements or project activities.
* Communicate status, risks, issues, and documentation needs clearly to project stakeholders and leadership.

Qualifications

* Bachelor's degree in Engineering, Computer Science, Information Systems, Life Sciences, or a related field.
* Experience as an engineer supporting IT compliance, computer system validation, or regulated systems within the pharmaceutical or life sciences industry.
* Strong understanding of CSV, GxP, validation lifecycle activities, documentation standards, and quality procedures.
* Experience executing validation testing and preparing or reviewing validation documentation.
* Ability to understand system requirements, perform hands-on execution, and document results accurately.
* Experience identifying and documenting non-conformances, deviations, and compliance gaps.
* Strong attention to detail and ability to produce audit-ready documentation.
* Ability to work cross-functionally with IT, Quality, Compliance, business, and technical teams.
* Strong communication, analytical, and problem-solving skills.
* Ability to operate in a fast-paced consulting environment and support client priorities with accountability and professionalism.

Send Us Your Resume
Send us your resume if you are exceptional and are interested in an opportunity to join a high growth management consulting firm. If you can answer yes to the below, let's talk:
Do you want to work on global pharmaceutical company initiatives?
Interested in joining a firm that has an extensive client base of leading life sciences companies, most of which are Fortune 100?
Do you have hands-on IT compliance or computer system validation experience in a regulated Life Sciences environment?

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