Manufacturing Support Engineer
About The Position
Lead equipment qualification activities according to industry standards to support drug product pharmaceutical manufacturing and R&D activities. Lead, facilitate, and participate in technical discussions to successfully resolve problems with equipment suppliers, methods, project issues, and deviations. Design, develop and deploy automation within manufacturing unit operations to ensure competitiveness and organizational excellence. Progress the technical understanding of process impact on drug product, ensuring consistent scientific excellence and scientific quality standards are met. Lead, support, and contribute to internal Fill/Finish activities in support of Lead Stability Development batch manufacturing. Responsible for ongoing production and continuous improvement initiatives. Opportunity to develop process engineering skills including the use of multiphysics software for process modeling and the statistical analysis of data.
Requirements
- Minimum of a BS in Biomedical Engineering or relevant engineering concentration with 5 years of experience (including co-op, internships or industry experience) is required.
- Experience in GxP automation equipment commissioning, qualifications, and life-cycle management are required.
- Experience and knowledge in GxP Fill/Finish applications is required.
- Effective communication skills by delivering information across multifunctional groups/sites and demonstrated leadership in providing integration of activities s are required.
- Authorization to work in the United States indefinitely without restrictions or sponsorship.
Nice To Haves
- MS with 2 years of work experience is preferred.
- Proficiency in sensors and signal conditioning, circuit design/analysis and automation control systems are preferred.
- Proven proficiency and experience in biologics (mAbs, gene therapies, cell therapies, etc.) within the pharmaceutical industry with a high level of technical understanding are preferred.
Responsibilities
- Lead equipment qualification activities according to industry standards to support drug product pharmaceutical manufacturing and R&D activities.
- Lead, facilitate, and participate in technical discussions to successfully resolve problems with equipment suppliers, methods, project issues, and deviations.
- Design, develop and deploy automation within manufacturing unit operations to ensure competitiveness and organizational excellence.
- Progress the technical understanding of process impact on drug product, ensuring consistent scientific excellence and scientific quality standards are met.
- Lead, support, and contribute to internal Fill/Finish activities in support of Lead Stability Development batch manufacturing.
- Responsible for ongoing production and continuous improvement initiatives.
Benefits
- Comprehensive medical coverage, dental, and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
