Senior Process Engineer (NS)
Prince Edward Island BioAlliance · Indiana, United States · 2 days ago
ManagementFull-time
About the role
The Senior Process Engineer will be responsible for leading process development and optimization activities, ensuring compliance with regulatory requirements, and supporting the manufacturing team in implementing new processes.
Responsibilities
- Lead process development and optimization activities for new products and existing processes
- Ensure compliance with regulatory requirements and Good Manufacturing Practices (GMP)
- Support the manufacturing team in implementing new processes and troubleshooting issues
- Collaborate with cross-functional teams to develop and implement process improvements
- Conduct risk assessments and develop mitigation strategies
- Develop and maintain technical documentation related to process development and operations
Requirements
- Bachelor's degree in Chemical Engineering, Biotechnology, Microbiology, or a related field
- Minimum 7 years of relevant experience in process development and manufacturing
- Experience with microbial fermentation, synthetic small molecules, ADC, HPAPI, plasmid DNA, mRNA, LNP, and sterile filling
- Strong understanding of GMP and regulatory requirements
- Excellent problem-solving and critical thinking skills
- Ability to work independently and in a team environment
Qualifications
- Knowledge of process analytical technologies (PAT)
- Experience with process simulation software (e.g., Aspen Plus, ChemCAD)
- Experience with data analytics and statistical process control (SPC)
- Strong communication and presentation skills
Skills
- Strong technical writing and documentation skills
- Proficiency in Microsoft Office Suite
- Experience with Lean Six Sigma methodologies
Benefits
- Competitive compensation package
- Flexible working hours
- Professional development opportunities
- Health insurance benefits
- Employee discounts on Agilent products
Pay
$80,000 - $120,000 annually
Schedule
Full-time, Monday through Friday, 8:00 AM - 4:30 PM