Process Engineer III/ IV- Small Molecule/ Oligo/ Peptide

Posted 8 Days Ago
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Cary, NC
In-Office
Senior level
Consulting
The Role
Lead small molecule process engineering projects, managing design, scale-up, compliance and mentoring staff while ensuring alignment with industry standards.
Summary Generated by Built In
Company Description

CRB is a leading provider of sustainable engineering, architecture, construction and consulting solutions to the global life sciences and food and beverage industries. Our more than 1,100 employees provide best-in-class solutions that drive success and positive change for our clients, our people and our communities. CRB is a privately held company with a rich history of serving clients throughout the world, consistently striving for the highest standard of technical knowledge, creativity and execution.

Job Description

We are seeking a skilled and experienced Process Engineer III/ IV 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

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.

Qualifications

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.

Additional Information

All your information will be kept confidential according to EEO guidelines.

CRB is committed to hiring and retaining a diverse workforce. We are proud to be an Equal Opportunity/Affirmative Action Employer and it is our policy to provide equal opportunity to all people without regard to race, color, religion, national origin, ancestry, marital status, veteran status, age, disability, pregnancy, genetic information, citizenship status, sex, sexual orientation, gender identity or any other legally protected category. Employment is contingent on background screening.

CRB does not accept unsolicited resumes from search firms or agencies. Any resume submitted to any employee of CRB without a prior written search agreement will be considered unsolicited and the property of CRB. Please, no phone calls or emails.

CRB offers a complete and competitive benefit package designed to meet individual and family needs.

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Top Skills

Cgmp
Chemical Engineering
Ema
Fda
Small Molecule Manufacturing
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The Company
HQ: Kansas City, MO
2,130 Employees
Year Founded: 1984

What We Do

CRB is a leading provider of sustainable engineering, architecture, construction and consulting solutions to the global life sciences and food & beverage industries. Our more than 1,700 employees provide best-in-class solutions that drive success and positive change for our clients, our people and our communities. CRB is a privately held company with a rich 35+ year history of serving clients throughout the world, consistently striving for the highest standard of technical knowledge, creativity and execution.

CRB is an equal opportunity employer -- M/F/D/V.

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