MES Business Analyst

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.

• →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.

• 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.