Position Overview

We are seeking an experienced MES Business Analyst to support a strategic SOP Review and Modernization Program within a highly regulated manufacturing environment. This role will serve as a key liaison between Manufacturing, Quality, and Subject Matter Experts (SMEs) to ensure Standard Operating Procedures (SOPs) are aligned with current manufacturing practices, Electronic Batch Records (EBRs), regulatory requirements, and operational objectives. The MES Business Analyst will be responsible for reviewing, remediating, and modernizing SOPs; standardizing procedural language; validating process accuracy; identifying opportunities for process improvement; and supporting training and implementation activities. The successful candidate will possess strong knowledge of Manufacturing Execution Systems (MES), GMP documentation practices, and biotechnology manufacturing operations.

Key ResponsibilitiesSOP Review and Remediation
Conduct detailed technical reviews of existing SOPs to assess accuracy, completeness, compliance, and alignment with current manufacturing processes. Remediate SOP content to address deficiencies, inconsistencies, outdated information, and compliance gaps. Migrate SOPs into approved corporate templates while ensuring adherence to document control standards. Convert narrative and descriptive content into clear, standardized, instruction-based procedural language.
MES and Electronic Batch Record Alignment
Review and compare SOP content against corresponding Electronic Batch Records (EBRs) and MES workflows. Ensure procedural instructions accurately reflect system configurations, manufacturing execution processes, and operational practices. Identify discrepancies between documented procedures and MES-enabled workflows. Support alignment of SOPs, EBRs, and manufacturing processes to improve consistency and compliance.Process Analysis and Continuous Improvement
Perform practice-versus-procedure assessments to evaluate operational adherence and identify gaps between documented procedures and actual practices. Analyze procedural workflows and recommend improvements to enhance efficiency, compliance, and usability. Identify opportunities for SOP consolidation, simplification, and standardization where appropriate. Document findings, recommendations, and improvement opportunities for stakeholder review.
Compliance and Documentation Quality
Review document structure, formatting, grammar, and terminology for compliance with GMP requirements and corporate documentation standards.
Ensure SOPs utilize appropriate regulatory, quality, and operational language. Verify procedural content supports inspection readiness and regulatory compliance expectations.
Stakeholder Collaboration
Partner with manufacturing, quality, validation, engineering, and operational SMEs to validate procedural content and technical accuracy. Facilitate working sessions, content reviews, and stakeholder discussions to resolve documentation issues and obtain approvals. Coordinate review cycles and support efficient resolution of reviewer comments and feedback. Track and document comment disposition and content revisions throughout the review process.Training and Implementation Support
Develop and update training materials associated with approved SOPs. Support training impact assessments and implementation planning activities.
Collaborate with business stakeholders to ensure successful adoption of updated procedures. Assist in change management activities associated with SOP modernization initiatives.

Required Qualifications

• Bachelor's degree in engineering, Life Sciences, Information Systems, Manufacturing, Business, or a related discipline.
• 3-7 years of experience in pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments.
• Experience working with Manufacturing Execution Systems (MES) and Electronic Batch Records (EBRs).
• Strong knowledge of GMP, GDP, and quality documentation requirements.
• Experience authoring, reviewing, remediating, or managing SOPs and controlled documents.
• Knowledge of Quality Management Systems (QMS), document management systems, and controlled documentation practices.
• Ability to analyze business processes and translate operational requirements into clear procedural documentation.
• Excellent written communication (English and Spanish), facilitation, and stakeholder management skills.

Preferred Qualifications:

• Experience with Plant Management Systems (PMS/POMS) or similar manufacturing operations platforms.
• Experience supporting SOP remediation, process standardization, or quality transformation initiatives.
• Lean, Six Sigma, or process improvement experience.