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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in small molecule API process development, scale-up, and manufacturing optimization, with a strong focus on regulatory compliance and technical documentation. Capable of leading project teams, mentoring junior engineers, and ensuring alignment with industry standards and guidelines.
Highest-signal resume keywords
Small Molecule Process EngineeringCGMP ComplianceChemical Synthesis and PurificationTechnical Report PreparationProject Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Process Flow DiagramsPiping and Instrumentation DiagramsMass/Energy BalancesChemical ReactorsFiltersCentrifugesDryersVacuum PumpsScrubbersProcess Compressed Gases
Soft Skills
Strong Written CommunicationStrong Verbal CommunicationMentoring
Tools & Technologies
3D Modeling SoftwareFactory Acceptance TestingRisk AssessmentsEngineering Controls
Certifications & Qualifications
EIT CertificationPE Certification
Industry Keywords
FDA GuidelinesEMA GuidelinesICH GuidelinesRegulatory ComplianceProcess 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 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
- Manage scope, budget, and schedule on small to medium-sized projects
- Support process design, scale-up, optimization, regulatory compliance, and client engagement
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 and experience with small molecule API manufacturing equipment and utility systems, including 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.)
- 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
- 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
- Equal Opportunity Employer
- Accommodation or alternative application process available for applicants with disabilities