Aurigene Pharmaceutical Services Limited | Aurigene Pharmaceutical Services Limited | Teamleader
4 days ago
Key Responsibilities
1️⃣ Process Engineering Leadership
- Process Modeling:
- Collaborate with modeling experts to develop kinetic, hydrodynamic, and unit operation models for process optimization and scale-up predictions.
- Unit Operation Optimization:
- Analyze experimental data using tools like Dynochem and G-Proms to identify key parameters.
- Design and implement robust control strategies for smooth and efficient operations.
- Evaluate technological solutions and conduct techno-economic analysis for informed decision-making.
- Process Scale-Up & Validation:
- Lead the development of engineering strategies for scaling up processes.
- Collaborate with R&D and cross-functional teams for technology transfer and troubleshooting.
- Conduct risk assessments, identify criticalities, and ensure the implementation of effective control strategies.
- Prepare project closure reports following agreed templates and timelines.
- Process Optimization:
- Drive Six Sigma and QbD methodologies to enhance process efficiency.
- Address and resolve technical challenges, focusing on crystallization and API formulation requirements.
2️⃣ Equipment & Utility Management
- Review and recommend suitable facilities and equipment for process requirements.
- Ensure compatibility of materials of construction (MoC) and perform risk assessments for equipment selection.
3️⃣ Safety, Compliance, and Documentation
- Lead safety evaluations by conducting risk assessments and reviewing PHA and HER reports.
- Oversee the preparation of GMP-compliant documents, including SOPs, protocols, and validation reports.
- Ensure adherence to regulatory guidelines and proactively address potential compliance challenges.
Key Qualifications
- Education: B.Tech in Chemical Engineering from a reputed institution.
- Experience: 15+ years of experience in process engineering with expertise in pharmaceutical or chemical manufacturing.
- Hands-on experience with tools like Dynochem, G-Proms, and process modeling software.
- Strong understanding of GMP, QbD, Six Sigma, and regulatory compliance standards.
- Proven ability to lead cross-functional teams, mentor team members, and manage complex projects.
✨ Why Join Aurigene?
- Be part of a leading organization driving innovation in the pharmaceutical industry.
- Lead cutting-edge projects with state-of-the-art tools and technologies.
- Enjoy a collaborative and inclusive work environment that fosters professional growth.
- Competitive salary and benefits package tailored to your expertise.
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