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.
FAQs
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