Process Engineering Lead for Pharmaceutical Excellence
5 days ago
Aurigene Pharmaceutical Services Limited seeks an exceptional Process Engineering Lead to drive technical excellence, ensure compliance, and foster people development.
Estimated salary: $120,000 - $180,000 per annum
Job Description:This role involves leading process development, optimization, and scale-up activities, driving technical excellence, ensuring compliance with regulatory and safety standards, supporting proposal submission, and engagement with clients, and fostering people development within the team.
Key Responsibilities:Process Development & Optimization:
- Scale up from lab to plant with thorough engineering optimization, ensuring robust process development and effective tech transfer to production.
- Evaluate RFPs, provide technical inputs, identify suitable facilities, and build client confidence in technical capabilities.
- Guide engineers on route selection, focusing on safety and scalability, and implement process improvements and adoption of innovative technologies.
Project Execution & Compliance:
- Oversee pre-tech transfer activities, troubleshoot technical challenges, monitor schedules, and manage documentation, ensuring adherence to cGMP, SLAs, and quality standards during audits and project reviews.
- Conduct facility evaluations, propose/guide technical upgrades, and ensure timely execution of projects.
Leadership & People Development:
- Mentor teams on technical and GMP compliance, identify training needs, support development, drive performance appraisals, and knowledge-sharing initiatives.
- Explore and implement innovative technologies in collaboration with internal teams and academic institutes.
Audit Support & Safety Compliance:
- Support customer and safety audits, close CAPA points, and ensure compliance with quality standards.
CAPEX & Budgeting:
- Initiate and oversee CAPEX projects, evaluate quotations, and ensure timely delivery and installation of equipment, managing departmental budgeting and resource allocation.
Cross-Functional Coordination:
- Collaborate across units to ensure seamless project movement, QC support, and on-time delivery.
Business Acumen:
- Align technical processes with strategic business goals, demonstrating success in building and leading a high-performing process engineering department.
- Proven ability to build client confidence and lead cross-functional teams.
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