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CRB

Senior Process Engineer- Small Molecule/ Oligo/ Peptide

RemoteUnited States only
Published
Experience
Senior
Employment
Full-time
Company size
Mid-size
$103.1k–$165k/yr
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Open to US only. Set where you work from to check your eligibility.

No BS summary

Seeking a Process Engineer with 5+ years of experience in small molecule API process development, scale-up, and manufacturing optimization. Must have a Bachelor's or Master's in Chemical Engineering and strong understanding of chemical synthesis, purification, and formulation. Experience with cGMP practices and designing engineering controls for potent APIs is required. Consulting or client-facing role experience is preferred.

Core skills

small molecule API manufacturingprocess designscale-up

Required skills

Chemical Engineeringsmall molecule process engineeringchemical synthesispurificationformulation processescGMPFDAEMAICH guidelinesprocess safetyrisk assessmentsHAZOPHACCP

Optional skills

EITPE certificationcommissioningstartupqualificationtroubleshooting of process systemsregulatory environmentsvalidation documentation

Required languages

English

What you'll do

  • 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.

What they require

  • 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.).
  • Demonstrated experience leading a small team of process engineers on complex engineering design projects.

Benefits

  • comprehensive insurance coverage
  • opportunity to participate in one or more annual incentive programs based on company and individual performance
  • complete and competitive benefit package designed to meet individual and family needs

CRB

CRB's nearly 1,200 expert professionals drive innovative, life-changing and life-saving solutions for manufacturers in the life sciences and food and beverage industries. Its mission, vision and core values put client satisfaction and employee experience at the center of everything it does.

Life SciencesEnterprise
$103.1k–$165k/yr