Position Title: MSAT Engineer
About the Role:
We are seeking a skilled MSAT (Manufacturing Science and Technology) Engineer to join our team and drive technical excellence in our manufacturing processes. In this role, you will collaborate with cross-functional teams to optimize and troubleshoot production workflows, ensuring compliance, efficiency, and quality in pharmaceutical manufacturing. This is an exciting opportunity to make a substantial impact on production innovation and product quality within a globally recognized company.
Key Responsibilities:
- Process Support & Optimization: Provide technical expertise to troubleshoot, optimize, and validate manufacturing processes for improved efficiency, consistency, and scalability.
- Tech Transfer: Lead technology transfer from R&D to manufacturing, working closely with development, production, and quality teams to ensure seamless process integration.
- Process Validation: Design and execute process validation activities, including preparation of validation protocols, data analysis, and final report generation to ensure regulatory compliance.
- Risk Assessment & Troubleshooting: Conduct risk assessments, root cause analysis, and implement corrective actions to resolve production issues and prevent recurrence.
- Data Analysis & Reporting: Monitor process data, perform statistical analysis, and report on key performance indicators (KPIs) to identify trends and implement continuous improvements.
- Quality & Compliance: Ensure all processes and procedures comply with current Good Manufacturing Practices (cGMP) and regulatory requirements.
- Cross-Functional Collaboration: Collaborate with R&D, Quality Assurance, Quality Control, Production, and Engineering teams to support the full lifecycle of pharmaceutical products.
Qualifications:
- Educational Background: Bachelor's or Master's degree in Chemical Engineering, Biochemical Engineering, Pharmacy, Biotechnology, or related field.
- Experience: Minimum of [X years] experience in pharmaceutical manufacturing, MSAT, process development, or a similar role, with hands-on experience in GMP environments.
- Technical Expertise: Strong knowledge of bioprocessing, drug formulation, or sterile manufacturing processes. Experience with technology transfer and process scale-up is preferred.
- Problem-Solving Skills: Demonstrated expertise in troubleshooting and process optimization, including root cause analysis and corrective/preventive action (CAPA).
- Regulatory Knowledge: Familiarity with cGMP, FDA, and EU regulations and guidelines.
- Communication Skills: Excellent written and verbal communication skills, with the ability to convey complex technical concepts effectively to cross-functional teams.
Preferred Qualifications:
- Experience with Six Sigma or Lean Manufacturing methodologies.
- Proficiency in data analysis tools (e.g., Minitab, JMP) and software relevant to process optimization.
- Previous experience in biologics or sterile pharmaceutical production.
Why Join Us
- Opportunity to work on innovative projects within a globally recognized company.
- Collaborative, dynamic work environment with room for professional growth.
- Competitive compensation and benefits package.
Please apply for the role via LinkedIn. Looking forward to connecting with you.
Registration No: R22106084
EA Licence No: 22S131
