Engineer

• 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

CRB

Senior Process Engineer – Small Molecule, Oligo, Peptide