Engineer, Biologics Purification, Upstream/Downstream/Tech Transfer - Remote; JP
Remote / Online - Candidates ideally in
Cambridge, Middlesex County, Massachusetts, 02138, USA
Listed on 2026-06-01
Cambridge, Middlesex County, Massachusetts, 02138, USA
Listing for:
3 Key Consulting
Remote/Work from Home
position Listed on 2026-06-01
Job specializations:
-
Engineering
Process Engineer, Quality Engineering, Biotechnology, Chemical Engineer
Job Description & How to Apply Below
Job Title: Engineer, Biologics Purification, Upstream/Downstream/Tech Transfer - Remote (JP15407)
Location: Cambridge MA, Remote
Employment Type: Contract
Business Unit: Drug Substance Technology Engineering Group
Duration: 1+ years with possible extensions and/or conversion to permanent
Posting Date: 5/21/2026
Pay Rate: $34 - $37/hour W2
Notes: Remote (Any TZ - Local to Cambridge, MA is highly preferred.
3 Key Consulting is hiring an Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.
Job Description:
Seeking a Process Development Engineer to join the Drug Substance Technology Engineering team at our client Cambridge site. Providing strong process engineering/ technology transfer support of human therapeutic drug substance products in clinical development through commercial production. Our mission is to translate developmental processes to commercial reality for patients through scientific expertise and engineering innovation. Knowledge of processes/equipment; scale-up factors, process deviations, quality attributes.
GMP experience is a plus.
The Engineer will apply upstream and downstream process engineering knowledge in support of technology transfer and clinical/commercial drug substance manufacturing in both stainless and single-use formats. Will partner with manufacturing, quality, analytical, and bench scientists to support a highly dynamic technology transfer.
JOB RESPONSIBILITIES:
Under guidance of senior staff, the Engineer will perform the following:
- Transfer processes for drug substance manufacturing and translate process improvements from the laboratory into manufacturing facilities
- Provide technical support for successful scale-up, transfer of process technology, and for clinical and/or commercial manufacturing operation. Experience is technical report writing an expectation.
- Assist in troubleshooting clinical and commercial runs
- Execute data trending and statistical process analysis
- Support technical direction for process-related deviations, CAPAs, and change controls
- Identify and support process-related operational excellence opportunities
- Represent process development and collaborates with other functions such as Manufacturing, Quality, and Regulatory.
- Experience related to Process characterization for manufacturing of biologics highly preferred. This includes technical support for authoring and review of process characterization reports.
Supplement additional workload on team.
BASIC QUALIFICATIONS:
Master's degree and 2 years of Engineering or Operations experience
Bachelor's degree and 4 years of Engineering or Operations experience
Associate's degree and 7 years of Engineering or Operations experience
High school diploma / GED and 8 years of Engineering or Operations experience
PREFERRED QUALIFICATIONS:
- Master's Degree in Chemical or Biochemical Engineering
- 2+ years of Process Engineering experience preferably related to downstream/ purification of commercial cGMP manufacturing facilities
- Background in biologics technology transfer into commercial facilities, new product introductions (NPIs)
- Biologics purification process knowledge:
Knowledge of upstream ( cell culture/bioreactor operations) or purification processes (chromatography, viral filtration/inactivation, ultrafiltration/diafiltration, and final fill. )/ equipment; scale-up factors, process deviations, quality attributes - Strong analytical capability, troubleshooting, and problem solving
- Independently motivated with ability to multi-task and work in teams, especially if remote or hybrid.
- Excellent written and verbal communication skills with technical writing and presentation experience. Experience in PC documentation, report reviews and technical writing preferred.
Skills:
- Cell culture experience, Purification /downstream experience, process characterization experience
- Nice to have:
Monoclonal antibodies or mAbs
manufacturing or on floor support
Assist senior staff in technical writing, process tech transfer, data monitoring
Red Flags:
No experience, not enough experience in biopharma or biotech, no experience in cell culture/upstream, purification/downstream or technical report writing
Interview process:
Teams interview. Screening 30 minute Microsoft team's interview with me. Second round
- Team's interview 30 minute each approximately with 3 other team members.
We invite qualified candidates to send your resume to . If you decide that you're not interested in pursuing this particular position, please feel free to take a look at the other positions on our website You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
Regards,
3KC Talent Acquisition Team
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