Senior Manager Manufacturing System Engineering - Bulk Drug Substance - Upstream

Skill Requirements

• High school diploma / GED and 12 years of engineering experience OR Associate’s degree and 10 years of engineering experience OR Bachelor’s degree and 8 years of engineering experience OR Master’s degree and 6 years of engineering experience OR Doctorate degree and 2 years of engineering experience
• At least 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources

Preferred Qualifications

• Degree in Electrical Engineering, Computer Science, Chemical Engineering or Biotech Engineering
• Extensive experience with Emerson DeltaV, Process Control Network design including network segregation, Process Control Systems: Virtual Infrastructure design and implementation, System Integration using OPC, Foundation Fieldbus, and Profibus
• Hands on experience with IO-Link technology for smart sensor/actuator integration in automated manufacturing environments
• Familiarity with Process Analytical Technology (PAT) tools and strategies for real-time process monitoring and control in biopharmaceutical manufacturing
• Direct knowledge of integrating various OEM automation software and field instrumentation technologies
• In-depth knowledge of industry standards such as 21 CFR Part 11, ASTM 2500, S88, S95, GAMP, GDP, and GMP
• Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.), experience interacting with regulatory agencies and inspectors, and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation
• Experience with Tech Transfer, Process Design, and Commissioning & Qualification
• Direct knowledge of biopharmaceutical production facility with direct experience with Upstream (Seed train, production Bioreactors, Harvest), and Downstream Purification (e.g. Chromatography and viral Filtration skids, UFDF), and CIP/SIP Skids
• Ability and willingness to mentor and develop engineering staff and embrace a team-based culture that relies on collaboration for effective decision-making
• Strong leadership, technical writing, and communication/presentation skills
• Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage