Sr Business Analyst

We are seeking an experienced Business Analyst with strong Life Sciences manufacturing expertise, specifically within sterile manufacturing environments and Manufacturing Execution Systems (MES). This role will support process harmonization, workflow standardization, and documentation efforts across regulated manufacturing operations. The individual will partner with cross-functional teams to translate operational processes into structured documentation, formal process maps, and standardized workflows to support validation, system design, and operational consistency.

This role is critical in environments where process variability exists and where standardization, compliance, and efficiency are key business priorities.

Key Responsibilities

• Process Analysis & Documentation
• Analyze current sterile manufacturing processes, workflows, and operational procedures.
• Develop formal process maps, workflow diagrams, and business process documentation.
• Document current-state and future-state process flows (As-Is / To-Be).
• Create standardized operating procedures and process frameworks to reduce variability.

MES & Manufacturing Support

• Collaborate with MES teams to define manufacturing workflows and system requirements.
• Translate business and operational needs into functional requirements for MES solutions.
• Support MES design, validation readiness, and implementation activities.
• Ensure alignment between manufacturing processes and system configuration.

Process Harmonization & Standardization

• Identify process inconsistencies across manufacturing operations.
• Drive process harmonization initiatives across sites, teams, or programs.
• Establish best practices and standardized approaches for regulated environments.
• Support continuous improvement initiatives.

Validation & Compliance Support

• Support creation of documentation that complements validation and design deliverables.
• Ensure documentation aligns with GMP, GxP, and regulatory requirements.
• Collaborate with Quality and Validation teams.

Stakeholder Engagement

• Work with Manufacturing, Quality, Engineering, Validation, and IT stakeholders.
• Facilitate workshops and process review sessions.
• Support cross-functional alignment and decision-making.

Required Experience & Skills

• Experience in Life Sciences manufacturing environments (pharma, biotech, medical device).
• Strong understanding of sterile manufacturing processes.
• Experience working with Manufacturing Execution Systems (MES).
• Process mapping and workflow documentation expertise (Visio, BPMN, etc.).
• Experience supporting regulated environments (GMP/GxP).
• Strong analytical, documentation, and stakeholder engagement skills.
• Ability to standardize processes across complex environments with high variability.

Preferred Qualifications

• Experience with process harmonization or global standardization programs.
• Experience supporting validation or system implementation initiatives.
• Lean / Six Sigma or process improvement experience.
• Familiarity with digital manufacturing or Industry 4.0 initiatives.