Pilot Plant Downstream Engineer
About The Position
The Pilot Plant Downstream Engineer plays a key role within R&D Pilot Operations, serving as a critical technical link between lab‑scale process development and full‑scale GMP manufacturing. This engineer will independently execute both routine and complex downstream purification operations, contribute to experimental planning, support documentation development (SOPs, batch records, reports), and perform data analysis using Spotfire or equivalent tools. Leveraging broad knowledge of downstream processes, industry practices, and scientific principles, the individual will consistently deliver high‑quality, timely, and reproducible results. Expertise in downstream operations—such as harvest clarification, chromatography, filtration, and buffer preparation—is required. Experience with AKTA systems and Unicorn software is preferred. Familiarity with upstream pilot‑scale operations is also valued.
Requirements
- Bachelor’s degree in Chemistry, Biology, Engineering, Pharmacy, or related field with 2+ years of relevant industry experience , or a Master’s degree (industry experience preferred).
- Required: hands‑on experience with downstream purification (chromatography, UF/DF, TFF, depth/sterile filtration).
- Experience supporting non‑GMP pilot‑plant operations at 50–1000 L bioreactor or equivalent downstream scale .
- Strong scientific problem‑solving and data analysis skills.
- Excellent communication and documentation abilities.
- Effective collaborator able to work across multi‑functional teams.
- Strong organizational skills with the ability to manage multiple priorities in a fast‑paced environment.
- Proficiency with laboratory and pilot‑scale equipment; upstream familiarity is a plus.
- Ability to wear PPE and perform physical tasks including lifting up to 25 lbs, standing up to 4 hours, and climbing ladders or accessing equipment platforms.
- Authorized to work in the United States indefinitely without restriction or sponsorship.
Nice To Haves
- Working knowledge of AKTA chromatography systems and Unicorn software preferred.
- Proficiency with laboratory and pilot‑scale equipment; upstream familiarity is a plus.
Responsibilities
- Execute non‑GMP downstream purification activities at pilot scale (50–1000 L) to support new product development, material supply, process characterization, and demonstration batches across the full development lifecycle, including post‑launch programs.
- Partner with Process Development and Manufacturing Sciences to troubleshoot downstream issues and contribute to large‑scale process investigations.
- Manage operational details such as long‑lead material tracking, sample planning, equipment scheduling, material ordering, and vendor coordination .
- Independently collect, interpret, and trend process data; identify deviations, patterns, and opportunities for optimization.
- Present results, technical challenges, and proposed solutions in project and departmental meetings.
- Contribute to the drafting and revision of pilot‑scale procedures, batch records, and technical documentation supporting process transfers and scale‑up.
- Support global technology transfer by providing technical insights, process data, and operational expertise.
- Assist with authorship of technical reports, study protocols, internal presentations, and—when applicable—scientific abstracts or conference materials.
- Identify, evaluate, and integrate new pilot‑scale technologies and digital tools to enhance R&D operational flexibility and downstream process capability.
- Drive continuous improvement initiatives focused on efficiency, process robustness, and advanced data analytics.
Benefits
- Excellent full-time benefits, including comprehensive medical coverage, dental, and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
- Yearly goal-based bonus & eligibility for merit-based increases
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
