Job Description
Job Description
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 cost-effectiveness.
- 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 non-conformances.
Technical Support :
- Provide technical support to production teams, troubleshoot process-related 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 cross-functional 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, scale-up, and validation in a GMP-regulated 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 cross-functional teams.
- Knowledge of regulatory requirements and quality systems in the pharmaceutical industry.
- Ability to manage multiple projects and prioritize tasks in a fast-paced environment.
Preferred Qualifications
- Certified Lean Six Sigma Green Belt or Black Belt.
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