Senior Process Engineer – Small Molecule, Oligo, Peptide

This is a fully remote position, open to applicants in Colorado.

📋 Description

• Lead and assist client projects that focus on the development, scale-up, and optimization of small molecule API processes.

• Perform site evaluations, gap analyses, and provide suggestions for process enhancements and compliance.

• Create process flow diagrams (PFDs), piping and instrumentation diagrams (P&IDs), as well as mass and energy balances.

• Convert client requirements into a practical design scope and document decisions, outstanding issues, and action items.

• Recognize and report any changes in scope or design deviations to project management.

• Work collaboratively with cross-functional teams, including architecture, mechanical, electrical, and construction professionals.

• Produce technical reports, proposals, and presentations tailored for both internal teams and client stakeholders.

• Assist in planning capital projects, including conducting feasibility studies, selecting equipment, and designing facilities.

• Ensure compliance with industry standards such as cGMP, FDA, EMA, and ICH guidelines.

• Engage in advanced project activities, including technical bid evaluations, vendor package management, factory acceptance testing, risk assessments (e.g., HAZOP, HACCP), 3D model reviews and coordination, and sequence of operations and functional specification reviews.

• Provide mentorship to junior engineers and design staff.

⛳️ Requirements

• Bachelor’s or Master’s degree in Chemical Engineering or a related field (ABET-accredited).

• At least 5 years of experience in small molecule process engineering, ideally in a consulting or client-facing role.

• Strong comprehension of chemical synthesis, purification, and formulation processes.

• Experience in design firms or operating companies within a related sector.

• Excellent written and verbal communication abilities.

• Intermediate familiarity with relevant industry and regulatory guidelines and building codes.

• Advanced technical expertise and experience with small molecule API manufacturing equipment and utility systems, including chemical reactors, filters, centrifuges, dryers, vacuum pumps, scrubbers, purified water systems, process compressed gases, and engineered heat transfer fluid systems.

• Experience in designing and implementing engineering controls for the containment of highly potent APIs.

• Familiarity with cGMP practices within regulated sectors (FDA, EMA, JP, etc.).

🏝️ Benefits

• Comprehensive insurance coverage.

• Opportunity to engage in one or more annual incentive programs based on both company and individual performance.