Senior Process Engineer – Life Sciences

This is a fully remote position, open to applicants in Colorado, +2 more states.

📋 Description

• Oversee, manage, and/or implement process engineering design activities across all project stages, from feasibility to construction.

• Formulate process operation strategies aimed at throughput, compliance, and operability, and facilitate process discovery workshops.

• Provide mentorship to junior engineers and engage in professional development activities.

• Create design documentation such as Process Flow Diagrams (PFDs), Piping and Instrumentation Diagrams (P&IDs), piping layouts, and equipment specifications.

• Conduct equipment sizing, mass and energy balances, and engineering calculations.

• Coordinate multidisciplinary teams and assign tasks to junior engineers.

• Utilize extensive knowledge and offer technical leadership in one or more biopharmaceutical manufacturing processes, including: Sterile fill/finish and aseptic processing (vial, syringe, cartridge, bag filling; lyophilization; isolator/RABS), Biologics manufacturing (bioreactor systems, cell culture, fermentation, upstream and downstream processing), API manufacturing (small molecule synthesis, peptide production, purification), Cell and gene therapy manufacturing (viral vector production, ex vivo cell processing), Oral solid dosage or other solid dose manufacturing.

• Lead design reviews and decision-making workshops, fostering client alignment on requirements and trade-offs.

• Interact with clients via workshops, field investigations, and technical documentation.

• Assist in marketing initiatives and proposal preparation.

• Execute feasibility assessments, process simulations, and risk evaluations.

• Provide mentorship to junior engineers and engage in professional development activities.

⛳️ Requirements

• Bachelor’s degree in Chemical Engineering or a related discipline AND 7+ years of pertinent experience.

• PE license is preferred, or the ability to obtain one.

• Experience in A&E consulting or pharmaceutical manufacturing is advantageous.

• Ability to lead and mentor junior engineers in specific focus areas within the life sciences industry or engineering design deliverables.

• Proven experience executing projects that involve process design, fluid mechanics, heat transfer, and/or mass balance principles.

• Background in reviewing and redlining process diagrams.

• Familiarity with process engineering software, including: Drawing tools (AutoCAD, Revit, Plant3D), Fluid flow, equipment sizing and design (AFT Fathom, Arrow), Capacity modeling and simulation (FlexSim, SchedulePro), HAZOP reviews and assessments (PHA Pro).

• Knowledge of process equipment pertinent to specific modalities, such as biologics (bioreactors, TFF, chromatography) and clean utilities (purified water, pure steam, compressed gases, aseptic fill/finish, or other relevant systems).

• Comprehension of various regulatory requirements and the ability to apply expectations appropriately across different submarkets.

• Exhibits advanced critical thinking and problem-solving abilities, with a knack for anticipating challenges and aiding others in resolving complex issues.

• Shows advanced collaboration capabilities, guiding teams through effective cross-discipline communication and collective problem-solving.

• Demonstrates strong communication skills, facilitating cross-disciplinary discussions and ensuring alignment on project goals.

• Exhibits advanced organizational skills, overseeing project planning, schedules, and group coordination to enhance efficiency.

• Proficient in Microsoft Office Suite and Bluebeam.

🏝️ Benefits

• Medical, dental, and vision insurance coverage.

• Life, accident, and disability insurance.

• 401(k) plan with company matching.

• Employee Assistance Program (EAP) and wellness initiatives.

• Paid company holidays, floating holidays, and flexible time off.

• Budget for professional development, conference participation, and leadership programs.

• Clear opportunities for advancement and mentorship.