A Sr Process Engineer 1 provides engineering technical guidance with limited or no direction, primarily focusing on client process fit within existing facility designs and specifying equipment and facility gaps for Drug Substance (DS) and Drug Product (DP) processes. This role champions transformation of engineering, manufacturing, and facility technologies, participates in industry forums, and provides technical engineering expertise for new processing equipment designs, installations and modifications to existing equipment and facility.

Serves as a technical leader in the client facility fit assessment and process design for equipment, facility, and operational capabilities
• Manages assessments and feasibility studies for prospective new and expanded capabilities for equipment, manufacturing, etc.
• Drives engineering studies to confirm process fit to plant for new processes and changes to existing processes
• Provides equipment design expertise and advice to guide major project(s) or other activities
• Leads equipment capital expenditure estimates
• Supports development of procurement packages by partnering with Project Engineering
• Identifies gaps, provides suggestions and drives implementation of improvements within the Drug Substance (DS) and Drug Product (DP) manufacturing areas
• Partners with the Process Engineering/Science teams as a lead for identifying process optimizations and potential bottlenecks
• Interacts with senior internal and external personnel on significant matters and cross-functional coordination, as required
• Provides regular updates to senior leadership on strategic initiatives, key technical efforts, facility fits and investments
• Serves as subject matter expert (SME) for process equipment & technologies, including upstream and downstream processes
• Supports site expansion project planning and future design
• Leads transition into technology transfer (detailed mass balance, equipment flow diagrams and technical consultation)
• Provides support to Program Management, Manufacturing, Technical Operations, EH&S, etc., concerning new client processes and equipment, as needed

Minimum Requirements:

• Bachelor's degree in Engineering or a related field with 8 years of Engineering or other relevant technical work experience; or
• Master's degree in Engineering or a related field with 6 years of Engineering or other relevant technical work experience
• Experience with Drug Substance or Drug Product process equipment and unit operations is required
• Prior experience working in a cGMP environment or other highly regulated industry