Pharmaceutical Manufacturing Support Engineer

The Role

The Pharmaceutical Manufacturing Support Engineer will lead equipment qualification activities, facilitate technical discussions, and contribute to internal Fill/Finish activities.

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.

Qualifications

• Education: 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. MS with 2 years of work experience is preferred.
• Experience: Experience in GxP automation equipment commissioning, qualifications, and life-cycle management are required. Experience and knowledge in GxP Fill/Finish applications is required. 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. Effective communication skills by delivering information across multifunctional groups/sites and demonstrated leadership in providing integration of activities are required.
• Authorization to work in the United States indefinitely without restrictions or sponsorship.

Additional Information

The position is full-time, Monday-Friday, generally 8 a.m. - 5 p.m., weekend work might be expected. Candidates currently living within a commutable distance of Malvern, PA are encouraged to apply.

Excellent full-time benefits include:

• Comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.