Senior Process Engineer – Small Molecule, Oligo, Peptide

This is a fully remote position, open to applicants in Kansas, +1 more state.

📋 Description

• Oversee and assist in client projects centered on the development, scaling, and optimization of small molecule API processes.

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

• Create process flow diagrams, piping and instrumentation diagrams, and perform mass/energy balance calculations.

• Convert client requirements into practical design scopes, documenting decisions, unresolved issues, and action items.

• Recognize and communicate scope alterations or design discrepancies to project leadership.

• Work collaboratively with architecture, mechanical, electrical, and construction teams.

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

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

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

• Carry out technical bid evaluations, vendor package oversight, factory acceptance testing, risk assessments, 3D model evaluations, operational sequence reviews, and functional specification assessments.

• Guide junior engineers and design personnel.

• Direct system design programming and planning, supported by senior engineers.

• Engage in cross-discipline squad checks to enhance overall project quality.

⛳️ 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.

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

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

• Excellent written and verbal communication skills.

• Intermediate familiarity with relevant industry and regulatory guidelines as well as building codes.

• Advanced technical expertise in small molecule API manufacturing equipment and utility systems.

• Experience in designing and implementing engineering controls for the containment of highly potent APIs.

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

• EIT or PE certification is preferred.

• Preferred experience in coordinating and managing design efforts within project teams and with external partners.

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

• Experience with regulatory environments and validation documentation is preferred.

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

• Awareness of 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 successful background screening.

🏝️ Benefits

• Comprehensive insurance coverage.

• Annual incentive programs based on individual and company performance.

• A complete and competitive benefits package tailored to meet the needs of individuals and families.

• Equal opportunity employer.

• Background screening.

• Disability accommodation or alternative application process.