Drug Product Development Pharmaceutical Manufacturing Support Engineer

Eurofins•Malvern, PA

1d•Onsite

About The Position

Eurofins Scientific is an international life sciences company providing analytical testing services. The company is a global leader in food, environment, pharmaceutical and cosmetic product testing. This role will lead equipment qualification activities according to industry standards to support drug product pharmaceutical manufacturing and R&D activities. The engineer will also lead, facilitate, and participate in technical discussions to resolve problems with equipment suppliers, methods, project issues, and deviations. Additionally, the role involves designing, developing, and deploying automation within manufacturing unit operations to ensure competitiveness and organizational excellence. The position will progress the technical understanding of process impact on drug product, ensuring consistent scientific excellence and scientific quality standards are met. The engineer will lead, support, and contribute to internal Fill/Finish activities in support of Lead Stability Development batch manufacturing, and will be responsible for ongoing production and continuous improvement initiatives. There is an opportunity to develop process engineering skills, including the use of multiphysics software for process modeling and 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.
Opportunity to develop process engineering skills including the use of multiphysics software for process modeling and the statistical analysis of data.