MSAT Engineer

Key Responsibilities

Project Planning & Execution

• Provide comprehensive project planning, including timelines and budget estimation.
• Monitor progress and ensure alignment with project objectives and regulatory requirements.
• Lead technical investigations and root cause analysis related to environmental monitoring and process performance.
• Design and support experiments to scientifically demonstrate root causes and corrective actions.
• Lead Environmental Monitoring Performance Qualification (EM PQ) activities across projects.
• Ensure effective communication and coordination among all relevant stakeholders.
• Guarantee compliance with EM PQ SOPs and applicable validation standards.
• Execute validation activities when required, ensuring robust scientific justification and documentation quality.

Compliance & Documentation

• Develop and review validation documentation to ensure compliance
• Ensure validation deliverables are scientifically sound, accurate, and audit-ready.

Process Validation & Risk Management

• Represent Process Validation in cross-functional teams.
• Participate in or moderate risk assessments to define validation and study scopes.
• Author and review validation protocols and reports, including:
  • Process validation studies
  • Hold time studies
  • Leachables & extractables studies
• Assess validation data against acceptance criteria and manage deviations with appropriate corrective measures.

Quality Systems & Compliance Support

• Act as SME in discrepancy investigations (Deviations) and Change Requests.
• Support the development and continuous improvement of SOPs and internal procedures.
• Ensure adherence to internal and external GMP standards throughout project execution.

Key Requirements

• Master's degree in Chemistry, Biotechnology, Life Sciences, or a related scientific field.
• 5 years of Proven experience in project management, preferably within MSAT, Quality, or Compliance functions.
• Strong background in biotechnological and/or chemical manufacturing processes.
• Demonstrated experience in validation methodologies and risk management principles.
• Significant experience in a GMP-regulated pharmaceutical environment, ideally within a Quality Unit.