About the Role
The MSAT Engineer is responsible for ensuring the efficient operation of pharmaceutical manufacturing and packaging processes. This role involves providing technical support, implementing process improvements, and enhancing productivity, product quality, and regulatory compliance. The engineer will work closely with cross-functional teams to troubleshoot issues, support continuous improvement initiatives, and ensure adherence to best practices in manufacturing and validation.
Responsibilities
- Serve as a subject matter expert (SME) within the Technical Services department, possessing in-depth knowledge in areas such as equipment qualification, process validation, temperature mapping, process improvement, and scale-up.
- Execute equipment qualification, process validation, and cleaning protocols. Prepare detailed qualification and validation reports to support operations and quality systems.
- Conduct trial runs or engineering batches according to written protocols. Develop critical process parameters to validate and improve manufacturing processes. Analyze results, provide recommendations, and prepare reports for operations review.
- Conduct premise temperature mapping for warehouse, production, and laboratory areas to ensure compliance with temperature control requirements.
- Lead deviation investigations, conduct process and quality troubleshooting, perform root cause analysis, and define corrective and preventive actions (CAPA) to resolve issues.
- Develop new batch manufacturing records (BMR) and batch packaging records (BPR) to support the production department in product realization.
- Perform troubleshooting and resolve process-related issues in collaboration with operations teams.
- Work closely with R&D, Quality Assurance, and Production teams on new product development and technology transfer projects.
- Oversee and manage the scale-up process from laboratory to production scale, ensuring smooth transitions and maintaining process integrity.
- Document all processes and maintain detailed records. Prepare technical documentation, including Standard Operating Procedures (SOPs), validation reports, and risk assessments, to ensure compliance with regulatory standards.
- Analyze process data and drive continuous improvement initiatives aimed at enhancing process efficiency and product quality.
- Provide training to production staff on new processes, technologies, and best practices to ensure operational effectiveness and compliance.
Qualifications
- A Degree in Science, preferably in Pharmacy, Pharmaceutical Technology, Chemistry, or Biochemistry.
- At least 3-4 years of experience in pharmaceutical validation, equipment qualification, process troubleshooting and improvement, scale-up processes, and process optimization.
- Familiarity with FDA regulations and cGMP guidelines, with a strong understanding of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) in a pharmaceutical manufacturing environment.
- Proficient in Microsoft Word, Excel, and PowerPoint.
- Strong command of English, both written and spoken, with the ability to read, comprehend, and write technical documentation. Excellent technical writing skills for preparing clear and concise documentation and reports.
- Strong problem-solving capabilities, analytical thinking, and attention to detail.
- Ability to work effectively in a team environment as well as independently, with minimal supervision.
Required Skills
- In-depth knowledge in areas such as equipment qualification, process validation, temperature mapping, process improvement, and scale-up.
- Strong problem-solving capabilities, analytical thinking, and attention to detail.
Preferred Skills
- Familiarity with FDA regulations and cGMP guidelines.
- Proficient in Microsoft Word, Excel, and PowerPoint.
Equal Opportunity Statement
We are committed to diversity and inclusivity in our hiring practices.
