Senior Downstream Process Engineer, Commercial

This is a fully remote position, open to applicants in California, +4 more states.

📋 Description

• Oversee the design of downstream processes, including Process Flow Diagrams (PFDs), Piping and Instrumentation Diagrams (P&IDs), mass balances, and equipment specifications.

• Create scalable solutions for harvesting, clarification, depth filtration, tangential flow filtration (TFF), and chromatography purification systems.

• Ensure adherence to current Good Manufacturing Practices (cGMP) and international regulatory standards.

• Lead the Front-End Loading (FEL) and Front-End Engineering Design (FEED) processes, transforming customer requirements into clear project scopes.

• Prepare detailed proposals that include scope, assumptions, risks, and exclusions with associated costs.

• Assist in developing CAPEX estimates that align with commercial objectives and margin targets.

• Act as the primary technical point of contact for clients and project teams.

• Facilitate design reviews, technical discussions, and presentations for executive stakeholders.

• Collaborate effectively across sales, engineering, and global teams.

• Contribute to technical marketing efforts, including white papers, webinars, and presentations.

• Offer technical guidance during the initial phases of projects as necessary.

⛳️ Requirements

• A Bachelor’s degree in Chemical Engineering, Biochemical Engineering, or a related technical discipline is required; a Master’s or PhD is preferred.

• A minimum of 8 years of experience in downstream process engineering, purification, or bioprocess system design within the biopharma or life sciences sector.

• Extensive knowledge in downstream processing techniques, including harvesting/clarification, depth filtration, TFF, and chromatography.

• Background in capital equipment projects and crafting complex engineering proposals.

• Proven experience in front-end engineering, process scale-up, and purification process design.

• Familiarity with single-use technologies and automation systems (e.g., PLC/SCADA, DeltaV) is preferred.

• Strong understanding of cGMP and global regulatory standards (FDA, EMA, ICH).

• Demonstrated ability to work collaboratively within cross-functional and global teams.

• Superior communication and presentation abilities, with experience engaging both technical and executive audiences.

• Capability to juggle multiple priorities in a dynamic, customer-focused environment.

🏝️ Benefits

• Health insurance

• 401(k)

• Paid time off (minimum of 120 hours)

• 10 paid holidays each year

• Paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave)

• Accident and life insurance

• Short- and long-term disability coverage

• Employee assistance and family support programs

• Commuter benefits

• Tuition reimbursement

• Employee Stock Purchase Plan (ESPP)