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HCG - Process Engineer Pharmaceutical Manufacturing
3 months ago
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.
