Data Integrity Analyst - Operations & Automation

Job Description

We are seeking a Data Integrity Analyst to support automation and manufacturing operations systems as part of a proactive Inspection Readiness Supply Chain project. This role will focus on automation-supported equipment and manufacturing systems within large molecule drug substance or drug product manufacturing environments. This position is not an Automation Engineer role and does not require coding or system configuration. Instead, the focus is on data integrity risk assessment, system evaluation, and GMP documentation related to automation-enabled equipment supporting commercial manufacturing.

Key Responsibilities

Support data integrity assessments for automation and operations systems supporting manufacturing equipment

Map and evaluate data flows for automation-supported systems to identify potential integrity risks

Author and support GMP documentation including data integrity risk assessments, reports, and remediation documentation

Partner with Automation and Operations SMEs to understand equipment functionality and system use without requiring deep automation engineering expertise

Support proactive inspection readiness activities by assessing system vulnerabilities related to data processing, controls, and documentation

Collaborate cross-functionally with Quality, Manufacturing, and Automation teams to support identified data integrity remediation efforts

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to [email protected] learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy:

Skills and Requirements

Bachelor's degree (scientific or technical discipline required)

2-6 years of technical experience (4 years ideal) supporting manufacturing, operations, or automation-enabled equipment in GMP environments

Exposure to automation-supported manufacturing equipment (no coding or system build experience required)

Experience performing or supporting data integrity risk assessments for systems or equipment

Strong experience with GMP documentation and technical writing

Comfortable working in highly regulated, onsite manufacturing environments -Empower experience

-Trackwise or Comet experience

-Background with HPLC instrumentation

-Experience with technical writing -- writing protocols and procedures, validation documentation

Experience working with 21 CFR Part 11 assessment or ANNEX 11 assessment