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

Overview

Lead small molecule API process design, scale-up, and optimization for pharma projects

Key Responsibilities

• scope changes
• technical reporting
• site assessment
• api development
• system design
• 3d modeling

Tasks

-Identify and escalate scope changes or design deviations to project leadership. -Participate in advanced project activities such as: -Prepare technical reports, proposals, and presentations for internal and client stakeholders. -Conduct site assessments, gap analyses, and provide recommendations for process improvements and compliance. -Lead and support client projects focused on small molecule API process development, scale-up, and manufacturing optimization. -Translate client requirements into actionable design scope and document decisions, open issues, and action items. -Lead system design programming and planning with support from senior engineers. -Support capital project planning including feasibility studies, equipment selection, and facility design. -Collaborate with cross-functional teams including architecture, mechanical, electrical, and construction. -Ensure alignment with industry standards including cGMP, FDA, EMA, and ICH guidelines. -Mentor junior engineers and design staff. -Develop process flow diagrams (PFDs), piping and instrumentation diagrams (P&IDs), and mass/energy balances. -3D model reviews and coordination -Participate in cross-discipline squad checks and drive overall project quality.

Requirements

• chemical engineering
• 5+ years
• api manufacturing
• pe certification
• cgmp
• hazop

What You Bring

-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. -Experience designing and implementing engineering controls for containment of highly potent APIs. -Prior experience in engineering consulting or client services. -Experience with regulatory environments and validation documentation. -Familiarity with commissioning, startup, qualification, and troubleshooting of process systems. -Experience coordinating and managing design within project teams and with external partners. -Experience in design firm or operating company settings within a related industry. -Familiarity with process safety, risk assessments, and HAZOP studies. -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. -Demonstrated experience leading a small team of process engineers on complex engineering design projects. -EIT or PE certification. -Strong understanding of chemical synthesis, purification, and formulation processes. -Intermediate experience with applicable industry and regulatory guidance and building codes. -Factory acceptance testing -Strong written and verbal communication skills. -Experience with cGMP practices within regulated industries (FDA, EMA, JP, etc.).

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About Crb

-Global design-build and consulting firm with international offices. -Integrating engineering, architecture, construction, and consulting. -Projects include biopharma facilities, processing plants, and research campuses. -Unified ONEsolution model streamlines design and construction delivery. -From a basement start to delivering high-tech labs and large-scale breweries globally.

Sector Specialisms

Security Clearance

-employment is contingent on background screening.