Senior Process Engineer

Senior Process Engineer (Pharma)

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 support automation design and qualification.
• Develop and execute Factory Acceptance Tests (FATs) and Site Acceptance Tests (SATs); support commissioning and qualification (C&Q) including Installation, Operational, and Performance Qualification (IQ/OQ/PQ) protocol development, execution support, discrepancy resolution, and turnover package review.
• Lead or independently support construction, startup, with minimal disruption to adjacent operating production.
• Interface directly with clients, quality and validation groups, contractors, equipment vendors, and project management.
• Manage assigned discipline scope, schedule, budget, and change-order identification.
• Maintain workload forecasts for process engineering staff on assigned projects.
• Mentor less experienced engineers and provide training on cGMP design, clean utilities, and contamination control fundamentals.

Minimum Qualifications

• Bachelor of Science in Chemical, Biochemical, or Mechanical Engineering.
• 10+ years of process engineering experience, with a substantial portion in pharmaceutical, API, or other cGMP-regulated manufacturing.
• Demonstrated process design experience in a regulated cGMP environment spanning feasibility and conceptual design through detailed design and construction support, including working knowledge of 21 CFR Parts 210/211, FDA expectations for facility, utility, and equipment design, and how design decisions drive qualification effort (URS, Design Qualification, FAT/SAT, IQ/OQ/PQ, process validation).
• Strong understanding of fundamentals in chemistry, fluid dynamics, heat and mass transfer, material and energy balances, and unit operations and separations relevant to pharmaceutical manufacturing, including drying, filtration, mixing, size reduction, and separation processes.
• Ability to visit project job sites to gather field information. Typical travel duration is up to 7 days, several times per year.

Desired Qualifications

• Professional Engineer (PE) license.
• Direct project experience in oral solid dosage, sterile fill-finish, API and both small & large molecule, or nutraceutical facilities.
• Knowledge of reaction kinetics, crystallization, and distillation as applied to API and drug substance manufacturing.
• Knowledge of ASME BPE (Bioprocessing Equipment) and ASME B31.3 (Process Piping).
• Knowledge of ASME BPVC Section VIII Div 1 for pressure vessel design.
• Familiarity with ISPE Baseline Guides, including Vol. 1 (Active Pharmaceutical Ingredients), Vol. 2 (Oral Solid Dosage Forms), Vol. 4 (Water and Steam Systems), Vol. 5 (Commissioning and Qualification), and Vol. 7 (Risk-Based Manufacture of Pharmaceutical Products).
• Familiarity with International Council for Harmonisation (ICH) guidelines Q7, Q8, Q9, and Q10, and with ISO 14644 cleanroom classification.
• Knowledge of NFPA Standards applicable to pharmaceutical manufacturing, including NFPA 30, 68, 69, 70, 497, 499, and 660.
• Familiarity with API 520/521/2000 for relief systems, and OSHA Process Safety Management (29 CFR 1910.119) where covered chemicals apply.
• Experience with closed-system and single-use technology strategies and their impact on facility classification and layout.
• Experience with containment design, Occupational Exposure Band and Occupational Exposure Limit (OEB/OEL) banding, and highly potent API handling.
• Familiarity with hydraulic modeling (e.g., PIPE-FLO) and process modeling software (e.g., Aspen Plus, ProSim, CHEMCAD).
• Experience developing scope, estimating hours, and scheduling professional labor for capital projects.

What We Offer

• Competitive base salary
• Generous bonus programs
• Paid Parental Leave
• PTO and Paid Holidays
• Paid overtime
• 401(k) with matching
• Health, Dental, and Vision
• Paid Charitable Effort Time
• Tuition Reimbursement
• Flexible Telecommuting Policy

Our Values: Be Inspiring Be Invested Be Improving Be Innovative Be Impactful Be Involved Be In Demand

Who We Are

Our Purpose: Creating Solutions, Improving Lives.BSI lives by the mantra“Serve the client, satisfy the employee”and we hold true to it in all aspects of our company. Our employees have consistently voted us a Top Workplace, commenting specifically on our dedication to company culture, employee appreciation, and employee well-being.

Founded in memory of a friend, BSI carries on the legacy of Bryan Speicher, who had a vision to create a company that gives back to its employees and community. Our founding president, Phil Beirne, helped cultivate this legacy, and Beirne & Speicher Inspired continues to grow and succeed. At the heart of it all, we are our people, and we are grateful that you are considering a career with BSI Engineering.