Senior Process Engineer – Small Molecule, Oligo, Peptide

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee and assist in client initiatives centered around small molecule API process development, scale-up, and optimization of manufacturing.

• Perform site evaluations and gap analyses, offering recommendations for enhancements and compliance.

• Create process flow diagrams, piping and instrumentation diagrams, and mass/energy balances.

• Convert client needs into actionable design specifications and document decisions, outstanding issues, and action items.

• Identify and report scope changes or design deviations to project management.

• Work in collaboration with architecture, mechanical, electrical, and construction teams.

• Draft technical reports, proposals, and presentations for both internal and client stakeholders.

• Assist in capital project planning, which includes feasibility studies, equipment selection, and facility design.

• Ensure compliance with cGMP, FDA, EMA, and ICH guidelines.

• Conduct technical bid tabulations, vendor package management, factory acceptance testing, risk assessments, 3D model evaluations, sequence of operations, and functional specification reviews.

• Guide junior engineers and design personnel.

• Lead system design programming and planning with assistance from senior engineers.

• Engage in cross-discipline squad checks and promote overall project quality.

• Manage scope, budget, and schedule for small to medium-sized projects.

• Facilitate process design, scale-up, optimization, regulatory compliance, and client interaction.

⛳️ Requirements

• Bachelor's or Master's degree in Chemical Engineering or a related field (ABET-accredited).

• At least 5 years of experience in small molecule process engineering.

• Strong knowledge of chemical synthesis, purification, and formulation processes.

• Experience in design firms or operating company environments within a related sector.

• Excellent written and verbal communication skills.

• Intermediate knowledge of relevant industry and regulatory guidance and building codes.

• Advanced technical expertise 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 in designing and implementing engineering controls for the containment of highly potent APIs.

• Familiarity with cGMP practices in regulated sectors (FDA, EMA, JP, etc.).

• EIT or PE certification is preferred.

• Experience in coordinating and managing design within project teams and with external partners is preferred.

• Familiarity with commissioning, startup, qualification, and troubleshooting of process systems is preferred.

• Experience with regulatory environments and validation documentation is preferred.

• Previous experience in engineering consulting or client services is preferred.

• Familiarity with process safety, risk assessments, and HAZOP studies is preferred.

• Proven experience leading a small team of process engineers on complex engineering design projects is preferred.

• Employment is contingent upon background screening.

🏝️ Benefits

• Comprehensive insurance coverage.

• Opportunity to participate in one or more annual incentive programs based on both company and individual performance.

• Complete and competitive benefits package tailored to meet individual and family needs.

• Equal Opportunity Employer.

• Accommodation or alternative application process available for applicants with disabilities.