Senior Process Engineer

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Mason, OH, US

Senior Process Engineer (Pharma)

Location: Mason, OH (preferred); open to consideration for opportunities in Oak Brook, IL, and Cedar Rapids, IA.
Your Role at BSI
Our Process Engineers design safe, compliant, and economic manufacturing systems for regulated drug product and drug substance manufacturing. You will work capital projects from concept through startup for clients producing oral solid dosage forms, active pharmaceutical ingredients (APIs), drug products, and nutraceutical and consumer health products. We design for patient safety, product quality, contamination control, throughput, regulatory compliance (FDA 21 CFR Parts 210/211 and current Good Manufacturing Practice, or cGMP), and total installed cost.
To support collaboration, mentorship opportunities, and effective project execution, BSI Engineering has adopted a hybrid work schedule in which employees are in the office a minimum of three days per week.

Responsibilities and Scope

• Lead site visits, walk-downs, and existing-condition surveys in operating cGMP facilities, including cleanroom classification assessments and utility capacity verification.
• Develop discipline scope, deliverables, assumptions, and estimated budget for proposals across greenfield, brownfield, capacity-expansion, and technology-transfer projects.
• Develop and review User Requirement Specifications (URS), Basis of Design (BOD), and Process Design Basis reports that capture client requirements and regulatory expectations in a single controlled document.
• Create Block Flow Diagrams (BFDs), Process Flow Diagrams (PFDs), Piping & Instrumentation Diagrams (P&IDs), and Mass & Energy Balances (M&EBs) for process, clean utility, and support systems.
• Design and specify clean utilities including PW, WFI, clean steam, process gases, and CIP/SIP systems, with attention to loop hydraulics, dead-leg control, sanitization, and material of construction and surface finish requirements.
• Develop process descriptions, contamination control strategy input, cross-contamination and segregation strategies, and regulatory and client compliance documentation.
• Perform equipment sizing, prepare specifications, prepare technical bid evaluations (TBEs), review vendor submittals and 3D models, and maintain equipment lists. Equipment scope routinely includes reactors, TFF systems, fillers, dryers (tray, vacuum, fluid bed, and lyophilizers), granulators, tablet presses, coaters, blenders, mills, isolators and Restricted Access Barrier Systems (RABS), autoclaves, parts washers, CIP/SIP skids, transfer panels, and clean utility generation and distribution.
• Coordinate process requirements with piping, mechanical, HVAC, electrical, automation, architectural, structural, and project management disciplines, including review of cleanroom layouts, pressure cascades, and construction documents for process intent.
• Perform process calculations using BSI spreadsheets and commercial software (e.g., PIPE-FLO for hydraulics); perform process simulation where applicable.
• Prepare process safety studies, relief calculations, code review studies and Occupancy reports, and Hazardous Area Classification (HAC) reviews and drawings for solvent-handling and API operations. Participate in Process Hazard Analyses (PHAs) and Dust Hazard Analyses (DHAs).
• Develop facility and equipment layouts consistent with cleanroom classification, unidirectional personnel and material flow, airlock strategy, closed-system processing, and containment requirements.
• Write process functional descriptions, operating procedures, and CIP/SIP sequences to…