Data Integrity Analyst - Operations & Automation Focus
Role details
Job location
Tech stack
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., * 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
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
Preferred Experience
- Experience within large molecule drug substance or drug product manufacturing environments strongly preferred
- Prior exposure to automation systems supporting commercial manufacturing
- Experience writing or contributing to data integrity risk assessments for automation systems
- Familiarity with regulated system landscapes (21 CFR Part 11 concepts)
- Experience working alongside Automation SMEs without needing extensive ramp?up time
Benefits & conditions
$38-45/hr
Exact compensation may vary based on several factors, including skills, experience, and education.
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.