MES Data Analyst – ALM

Job Responsibilities Extract, review, and analyze MES validation data within Application Lifecycle Management (ALM) systems, including user requirements, test results, deviations, and supporting documentation. Required Qualifications Approximately 5+ years of relevant experience in MES applications, particularly Syncade, ALM, validation data analysis, technical reporting, or computerized system validation.

Title : MES Data Analyst ALM

Location: Remote (U.S.)

Employment Type: Contract

Duration: 6 Months (Initial)

Job Responsibilities

• Extract, review, and analyze MES validation data within Application Lifecycle Management (ALM) systems, including user requirements, test results, deviations, and supporting documentation.

• Review validation records to verify requirements traceability, testing completeness, and alignment between validation evidence and system requirements.

• Analyze test results and deviations to identify trends, discrepancies, and areas requiring further investigation.

• Prepare consolidated validation reports, statistical summaries, and technical documentation.

• Support validation reporting for standardized MES configurations, reusable system components, and implementations across multiple manufacturing sites.

• Collaborate with MES, Quality, Validation, and technical teams to manage deliverables and meet project timelines.

Required Qualifications

• Approximately 5+ years of relevant experience in MES applications, particularly Syncade, ALM, validation data analysis, technical reporting, or computerized system validation.

• Experience with ALM systems and validation data extraction and analysis.

• Experience reviewing User Requirements Specifications (URS), validation test results, and requirements traceability.

• Knowledge of deviation analysis, trending, and validation report generation.

• Strong analytical skills and exceptional attention to detail.

• Ability to independently manage documentation reviews in a regulated environment.

Preferred Qualifications

• Experience in GMP pharmaceutical manufacturing environments.

• Knowledge of Computerized System Validation (CSV) and MES configuration.

• Experience supporting global MES implementations and reusable MES libraries.

• Familiarity with Veeva, statistical analysis tools, or AI-enabled data analysis.

Pay Scale

• Anticipated hourly pay range: $35/hr to $39/hr on W2.

Benefits

Employees hired into this position are eligible for the following benefits, subject to the applicable plan terms and eligibility requirements:

Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.

Retirement Benefits: A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.

Paid Time Off (PTO): No PTO other than that required by applicable state and local laws.