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Senior System Analyst, Enterprise Apps, Tech Ops

OperationsOperationsFull TimeRemoteTeam 1,001-5,000H1B No SponsorCompany Site LinkedIn

Location

Massachusetts

Posted

48 days ago

Salary

$99.4K - $123.8K / year

Bachelor Degree5 yrs expEnglishERP

Job Description

• Serve as the primary expert responsible for governance, documentation, and compliance lifecycle of GxP-critical SAP Enterprise Applications • Lead the development, review, and maintenance of GxP-critical documentation • Collaborate with business users to finalize User Requirements Specifications • Maintain the document repository for validation and change records • Lead the change control process for all SAP system modifications • Conduct thorough Impact Assessments for GxP system changes • Prepare and maintain comprehensive Test Documentation and lead execution of validation testing • Act as primary liaison between IT functional teams, Quality Assurance, and key business process owners

Job Requirements

Minimum of 5+ years of experience in a System Analyst, Business Analyst, or Functional Consultant role supporting SAP ERP systems
5+ years of direct, hands-on experience leading GxP Change Control and Validation execution within the pharmaceutical, biotech, or life sciences industry
Expertise in GxP regulations including 21 CFR Part 11, GAMP 5, and Computer System Validation principles
Proven experience in authoring GxP Documentation (SOPs, WIs, URS, FS, Test Scripts, Validation Protocols)
Deep functional knowledge of at least two core SAP modules relevant to Pharma (e.g., QM, PP, MM, SD)
Strong analytical and problem-solving skills
Excellent communication and interpersonal skills