Senior Process Engineer – Small Molecule, Oligo, Peptide

🔥 13 hours ago

🇺🇸 United States – Remote

💵 $103.1k - $165k / year

⏰ Full Time

🟠 Senior

👷🏻‍♀️ Engineer

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CRB

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1984

💼 Consulting

🍽️ Food & Beverage

🏥 Healthcare

Consulting • Food & Beverage • Healthcare

CRB is a company that offers a comprehensive suite of software solutions for businesses, including marketing automation, sales CRM, customer service tools, content management systems, and operations software. Their unified HubSpot CRM platform integrates various functionalities designed to enhance customer relationship management and streamline business processes, providing both free and premium plans to cater to different business needs.

📋 Description

• 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

• 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

• 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