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Senior Process Engineer – Small Molecule, Oligo, Peptide
Location
Colorado
Posted
97 days ago
Salary
$100K - $160K / year
Seniority
Senior
Job Description
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. • 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.
Job Requirements
- 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.)
Benefits
- comprehensive insurance coverage
- opportunity to participate in one or more annual incentive programs based on company and individual performance
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