We are seeking a highly skilled and motivated Process Engineer to join our pharmaceutical manufacturing team. The Process Engineer will play a crucial role in optimizing manufacturing processes ensuring product quality and improving operational efficiency. This position requires a deep understanding of pharmaceutical manufacturing principles process engineering and regulatory compliance.
Key Responsibilities
Process Optimization:
- Develop evaluate and optimize manufacturing processes to enhance efficiency quality and costeffectiveness.
- Identify and implement process improvements to reduce waste increase yield and improve overall production performance.
Quality Assurance:
- Ensure all manufacturing processes comply with Good Manufacturing Practices (GMP) regulatory standards and company quality policies.
- Conduct root cause analysis and corrective actions for process deviations and nonconformances.
Technical Support:
- Provide technical support to production teams troubleshoot processrelated issues and recommend solutions.
- Collaborate with R&D Quality Control and other departments to ensure smooth technology transfer and process validation.
Documentation and Compliance:
- Prepare and maintain detailed documentation including Standard Operating Procedures (SOPs) process flow diagrams and validation protocols.
- Ensure compliance with all regulatory requirements including FDA EMA and other relevant agencies.
Project Management:
- Lead or participate in crossfunctional project teams to develop and implement new processes equipment and technologies.
- Manage project timelines budgets and resources effectively to ensure successful project completion.
Continuous Improvement:
- Drive continuous improvement initiatives by implementing Lean Manufacturing Six Sigma and other methodologies.
- Conduct regular process audits and reviews to identify areas for improvement and implement best practices.
Requirements
Education: Bachelor s or Master s degree in Chemical Engineering Biochemical Engineering Pharmaceutical Engineering or a related field.
Experience:
- Minimum of 5 years of experience in process engineering within a pharmaceutical manufacturing environment.
- Experience with process optimization scaleup and validation in a GMPregulated setting.
- Strong background working with Emerson DCS SCADA Siemens or Allen Bradley PLCs MES LIMS BMS ERPs
- Excellent communication and interpersonal skills to collaborate effectively with crossfunctional teams.
- Knowledge of regulatory requirements and quality systems in the pharmaceutical industry.
- Ability to manage multiple projects and prioritize tasks in a fastpaced environment.
Preferred Qualifications
- Certified Lean Six Sigma Green Belt or Black Belt.