Job Description

• Support of Single Use network in terms of design and investigation
• Use process engineering and equipment design experience, to assess unit operation performance and work with both suppliers and the internal network to resolve equipment and single use consumable challenges.
• Analyze available data, research technical subjects, and work with other subject matter experts to support resolution of critical investigations.
• Provide leadership on capital projects.
• Provide process development representation on capital projects, ensuring process requirements are incorporated into equipment and facility designs.
• Support and/or lead design of flexible manufacturing equipment and single use consumables, including support of factory acceptance testing and onsite commissioning and qualification.
• Support the client’s single use global network as a drug substance domain expert.

• Background in Single Use Technologies
• Background in Process Engineering
• Project management skills
• Validation experience

• High school diploma/GED and 12 years of Engineering or Operations experience OR Associate’s degree and 10 years of Engineering or Operations experience OR Bachelor’s degree and 5 years of Engineering or Operations experience OR Master’s degree and 3 years of Engineering or Operations experience OR Doctorate degree

• Master’s degree and 6+ years of directly related experience, or PhD with 2+ years of directly related experience
• Strong understanding of GMP equipment design and biologics manufacturing requirements
• Detailed knowledge of multiple unit operations
• Experience leading root cause analyses and solving GMP manufacturing issues
• Ability to apply sophisticated problem solving skills within defined constraints
• Experience providing process engineering support of pilot/clinical/commercial processes