Job Description

Key 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.

Qualifications:

• 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 s are required.

Additional Information

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 including 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.