Senior Process Engineer Job

• Responsible for concept, basic, and detailed engineering for biotech and pharmaceutical equipment and facilities
• Involved in greenfield, brownfield, and revamp projects for biotech and pharmaceutical equipment and facilities
• Developing P&IDs, process flow diagrams, process mapping, and engineering calculations
• Supporting manufacturing of monoclonal antibodies, vaccines, plasma fractionation, and continuous processing procedures and flows
• Authoring and reviewing Standard Operating Procedures (SOPs), facility fit assessments, technology transfer documents, and process flow diagrams for molecule scale-up
• Leading customer interface activities for various blocks during project initiation and completion
• Authoring and reviewing Commissioning and Qualification Master Plans, and related Commissioning and Qualification documentation
• Executing equipment functionality testing
• Using multiple software/platforms (Step7, PCS7, DeltaV, WinCC) with expertise in developing and executing sequences of operations, including safety alarms and interlocks
• Use skills including: AutoCAD, Microsoft Visio, Bluebeam, ValGenesis, Kneat, Unicorn, Hazard and Operability Study (HAZOP), Failure Modes and Effects Analysis (FMEA), Process Closure Risk Assessment.

Education: Bachelor’s degree in Biotech Engineering, or Biotechnology, or closely related field of study in Engineering Discipline.

Experience:
• One year of experience in development and review of User requirement specifications, system level impact assessment, design qualification, Requirement traceability matrix, Installation and Operational Qualification, Performance Qualification Protocols, and Equipment Functionality Testing;
• One year of experience in biopharmaceutical equipment and systems such as Bioreactors, Chromatography, Tangential Flow Filtration, Centrifugation, Buffers, Clean-In-Place, Water for Injection.

Skills and knowledge: knowledgeable on Commissioning and Qualification guidelines Commissioning and Qualification and GAMP guideline; skills in AutoCAD, MS Visio, Bluebeam, Valgenesis and KNEAT.

Contact: HR, MMR Consulting USA, Inc., 15255 South 94th Avenue, Orland Park, IL 60462. Ref # SRMMR2026