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CRB

Senior Process Engineer – Small Molecule, Oligo, Peptide

CRB

. Lead and support client projects focused on small molecule API process development, scale-up, and manufacturing optimization .

Posted 9/15/2026full-timeRemote • Kansas • United StatesSenior💰 $103,125 - $165,000 per yearWebsite

Core Competencies

Role fit
Core Competencies

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Demonstrates expertise in small molecule API process development, including design, optimization, and compliance with regulatory standards such as cGMP, FDA, and EMA. Capable of leading project teams, conducting technical assessments, and mentoring junior engineers while ensuring project quality and alignment with client requirements.

Highest-signal resume keywords
Small Molecule Process EngineeringCGMP PracticesChemical Synthesis and PurificationTechnical Report PreparationProject Leadership

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills
Process Flow DiagramsPiping and Instrumentation DiagramsMass/Energy BalancesEngineering Controls for ContainmentFactory Acceptance TestingRisk Assessments3D Model ReviewsFunctional Specification ReviewsDesign ImplementationRegulatory Compliance
Soft Skills
Strong Written CommunicationStrong Verbal CommunicationMentoringCollaborationProblem-Solving
Certifications & Qualifications
EIT CertificationPE Certification
Industry Keywords
API Manufacturing EquipmentRegulatory EnvironmentsValidation DocumentationProcess SafetyHAZOP Studies

About the role

Key responsibilities & impact
  • Lead and support client projects focused on small molecule API process development, scale-up, and manufacturing optimization
  • Conduct site assessments and gap analyses, and provide recommendations for process improvements and compliance
  • Develop process flow diagrams, piping and instrumentation diagrams, 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 architecture, mechanical, electrical, and construction teams
  • 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 cGMP, FDA, EMA, and ICH guidelines
  • Perform technical bid tabulations, vendor package management, factory acceptance testing, risk assessments, 3D model reviews, sequence of operations reviews, 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

Requirements

What you’ll need
  • 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
  • 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 of small molecule API manufacturing equipment and utility systems
  • Experience designing and implementing engineering controls for containment of highly potent APIs
  • Experience with cGMP practices within regulated industries (FDA, EMA, JP, etc.)
  • EIT or PE certification preferred
  • Experience coordinating and managing design within project teams and with external partners preferred
  • Familiarity with commissioning, startup, qualification, and troubleshooting of process systems preferred
  • Experience with regulatory environments and validation documentation preferred
  • Prior experience in engineering consulting or client services preferred
  • Familiarity with process safety, risk assessments, and HAZOP studies preferred
  • Demonstrated experience leading a small team of process engineers on complex engineering design projects preferred
  • Employment is contingent on background screening

Benefits

Comp & perks
  • Comprehensive insurance coverage
  • Annual incentive programs based on company and individual performance
  • Complete and competitive benefit package designed to meet individual and family needs
  • Equal opportunity employer
  • Background screening
  • Disability accommodation or alternative application process