Senior Process Engineer- Small Molecule/ Oligo/ Peptide

Senior Process Engineer- Small Molecule/ Oligo/ Peptide

We are seeking a skilled and experienced Process Engineer III/ IV or V with deep expertise in small molecule manufacturing to join our engineering consulting team. This role combines technical leadership with strategic client engagement, supporting process design, scale-up, optimization, and regulatory compliance across a variety of pharmaceutical and chemical industry projects.

The Process Engineer III will lead the design and execution of process scopes—such as unit operations, systems, or facility areas—on small to medium-sized projects. You will manage scope, budget, and schedule, while maintaining clear communication with clients and internal teams. This role also includes mentoring junior staff, contributing to high-quality deliverables, and supporting capital project planning and regulatory alignment.

This position can be based near any CRB location, remote option will be considered.

Key Responsibilities

• Lead and support client projects focused on small molecule API process development, scale-up, and manufacturing optimization.
• Conduct site assessments, gap analyses, and provide recommendations for process improvements and compliance.
• Develop process flow diagrams (PFDs), piping and instrumentation diagrams (P&IDs), and mass/energy balances.
• Translate client requirements into actionable design scope and document decisions, open issues, and action items.
• Identify and escalate scope changes or design deviations to project leadership.
• Collaborate with cross-functional teams including architecture, mechanical, electrical, and construction.
• Prepare technical reports, proposals, and presentations for internal and client stakeholders.
• Support capital project planning including feasibility studies, equipment selection, and facility design.
• Ensure alignment with industry standards including cGMP, FDA, EMA, and ICH guidelines.
• Participate in advanced project activities such as:
  • Technical bid tabulations
  • Vendor package management
  • Factory acceptance testing
  • Risk assessments (e.g., HAZOP, HACCP)
  • 3D model reviews and coordination
  • Sequence of operations and functional specification reviews
• Mentor junior engineers and design staff.
• Lead system design programming and planning with support from senior engineers.
• Participate in cross-discipline squad checks and drive overall project quality.

Minimum Qualifications

• Bachelor's or Master's degree in Chemical Engineering or a related discipline (ABET-accredited).
• Minimum of 5 years of experience in small molecule process engineering, preferably in a consulting or client-facing role.
• Strong understanding of chemical synthesis, purification, and formulation processes.
• Experience in design firm or operating company settings within a related industry.
• Strong written and verbal communication skills.
• Intermediate experience with applicable industry and regulatory guidance and building codes.
• Advanced technical knowledge and experience with small molecule API manufacturing equipment and utility systems, such as chemical reactors, filters, centrifuges, dryers, vacuum pumps, scrubbers, purified water, process compressed gases, and engineered heat transfer fluid systems.
• Experience designing and implementing engineering controls for containment of highly potent APIs.
• Experience with cGMP practices within regulated industries (FDA, EMA, JP, etc.).

Preferred Qualifications

• EIT or PE certification.
• Experience coordinating and managing design within project teams and with external partners.
• Familiarity with commissioning, startup, qualification, and troubleshooting of process systems.
• Experience with regulatory environments and validation documentation.
• Prior experience in engineering consulting or client services.
• Familiarity with process safety, risk assessments, and HAZOP studies.
• Demonstrated experience leading a small team of process engineers on complex engineering design projects.

The pay range for a candidate selected for this position who is based in Denver is typically $103,125 to $165,000 annually. The base salary range represents the low and high end of the salary range for this position. The selected candidate's actual pay will be based on various factors, including but not limited to work location, qualifications, and relevant experience. In addition, CRB offers a total rewards package that includes comprehensive insurance coverage as well as the opportunity to participate in one or more annual incentive programs based on company and individual performance.