Position Summary The
Senior Engineer provides advanced technical support to manufacturing operations within a biotechnology/pharmaceutical environment. This role focuses on
Drug Substance processes, ensuring compliance with
GMP standards, optimizing manufacturing performance, and supporting continuous improvement initiatives.
Key Responsibilities - Provide engineering support for biopharmaceutical manufacturing operations, with a focus on Drug Substance processes
- Serve as Deviation Owner for major deviations, leading investigations, performing root cause analysis, and ensuring timely closure with effective CAPA implementation while maintaining full GMP compliance
- Ensure compliance with GMP regulations and company quality standards
- Lead troubleshooting efforts for process and equipment issues to minimize downtime
- Drive continuous improvement initiatives to enhance process efficiency, reliability, and cost-effectiveness
- Provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment
- Collaborate with cross-functional teams including Manufacturing, Quality, Validation, and Supply Chain
- Utilize and maintain documentation in systems such as SAP, TrackWise, PAS/X (electronic batch records), and Veeva
- Support process validations, change control activities, and regulatory inspections
- Provide technical guidance and mentorship to junior engineers and team members
Qualifications - Education
- Doctorate degree OR
- Master's degree + 2 years of Engineering experience OR
- Bachelor's degree in Engineering + 4 years of Engineering experience
- Experience in biotechnology/pharmaceutical manufacturing, especially Drug Substance processes
- Strong knowledge of GMP manufacturing systems and regulatory requirements
- Hands-on experience with:
- SAP
- TrackWise
- PAS/X (electronic batch records)
- Veeva document management systems
- Strong problem-solving, analytical, and technical skills
- Excellent communication and cross-functional collaboration abilities
