Process/Project Engineer
15 days ago
Philadelphia
Process / Project Engineer (Biotech/Pharma) Location – Philadelphia, PA Please note: We are only considering W2 candidates at this time. Applications from third-party vendors or C2C arrangements will not be considered. ADVENT Engineering is an engineering and consulting firm providing expertise to the pharmaceutical and biotechnology industries. Headquartered near San Francisco, California, and with operations in the Eastern and Western US, Canada and Singapore, our company is involved in almost every facet of global pharmaceutical and biotechnology facility design and process engineering and quality system projects. ADVENT's services include process engineering, automation engineering, project engineering, facility/system design, start up and commissioning, validation and compliance consulting for distinguished and successful biotechnology and pharmaceutical manufacturing companies. The successful candidate will work with a group of engineers involved in the design, automation, commissioning and start-up of various processes, systems and facilities. A combination of strong technical aptitude, automation engineering skills and technical writing are the desired skill set. This is an outstanding opportunity to join our growing team! Role Summary The ADVENT Engineering division of Trinity Consultants is seeking a versatile Process/Project Engineer with strong process fundamentals and the ability to support clients transitioning away from open‑top solvent‑based degreasing processes to more sustainable, compliant, and operationally robust solutions. This role blends hands‑on engineering, cross‑functional coordination, and client‑facing consulting—ideal for someone who can operate in both regulated (GMP) and industrial environments. Key Responsibilities Process Engineering (Industrial + GMP‑aligned) • Perform end‑to‑end process engineering across feasibility, design, implementation, and qualification for solvent‑replacement and precision‑cleaning operations., • Develop URS, process flow diagrams (PFDs), mass/energy balances, material compatibility analyses, and technology down‑selection for aqueous, alkaline, ultrasonic, or other solvent‑free systems., • Evaluate process impacts on upstream/downstream steps, equipment utilization, production throughput, and product integrity., • Author or review process documentation such as URS, risk assessments, functional specifications, commissioning/qualification‑ready inputs, and change‑control impacts., • Support integration of new or modified equipment, including facility impact assessments, utilities, ventilation, controls, and workflow considerations., • Lead structured technology assessments using decision matrices grounded in process performance, materials compatibility, cost, and safety/environmental considerations., • Coordinate with architectural/engineering partners to define and execute mechanical, electrical, controls, ventilation, and facility‑modification needs., • Follow and reinforce client and Trinity safety expectations, including participation in JHA/JSA, ensuring PPE compliance, applying safe‑work practices, and using stop‑work authority when necessary., • Prepare clear, structured, client‑ready communication such as options analyses, engineering justifications, and risk/benefit assessments., • Demonstrate Trinity core consulting competencies including quality ownership, client responsiveness, continuous improvement, collaboration, communication excellence, and problem solving., • Contribute to early‑phase work such as scoping, estimating, and resource planning., • Support ongoing client relationship development and act as a trusted technical advisor. Required Qualifications • B.S. in Chemical, Mechanical, Materials Engineering, or related discipline., • 5–8+ years of process engineering experience in industrial manufacturing or similar technical environments., • Experience with solvent‑replacement, cleaning/degreasing operations, or related unit operations (aqueous, alkaline, ultrasonic, precision cleaning)., • Understanding of solvent‑use regulations, chemical exposure controls, and basic industrial ventilation principles., • Demonstrated ability to execute process changes from URS through design, procurement, installation, and commissioning/start‑up., • Strong communication and client‑facing consulting skills. Strongly Preferred Qualifications (GMP‑Focused) GMP experience is a significant advantage but not required. • Experience supporting GMP manufacturing or other regulated environments., • Familiarity with GMP documentation such as change controls, deviations, risk assessments, URS, and qualification lifecycle (DQ/IQ/OQ/PQ)., • Experience integrating new process equipment into GMP workflows or collaborating with CQV teams., • Understanding of data integrity expectations and traceability requirements. Additional Preferred Qualifications • Experience replacing open‑top vapor degreasers or conducting comparative cleaning trials in quality‑critical environments., • Knowledge of materials compatibility and corrosion considerations when transitioning from chlorinated solvents to aqueous/alkaline chemistries., • Exposure to CFD or capture‑system evaluations for emissions control or environmental modeling. Travel Requirements • Primarily remote., • Flexibility to travel to client sites on the East Coast for design reviews, trials, FAT/SAT, installation, and start‑up., • Some projects may require 100% on‑site presence depending on operational needs.