Process Engineer – Biotech Downstream/Tech-Transfer (JP14390)
Cambridge, MA · Biotech/Pharmaceutical
Job Title: ProcessEngineer – Biotech Downstream/Tech-Transfer (JP14390) Location: Cambridge, MA. 02138 / Hybrid or Remote Employment Type: Contract Business Unit: Internal and External PE Duration: 1+ years (with likely extensions and/or conversion to permanent) Rate: $36 - $41/ hour W2 with benefits Posting Date: 08/14/2025 Notes: This position can be Hybrid or Remote. Standard Business hours.
Local to Cambridge MA or Thousand Oaks CA would be nice but not necessary.
3 Key Consulting is hiring an Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.
Ideal candidate: 3+ years of industry experience, comfortable presenting. Biologics/ drug substance purification experience required (Chromatography, filtration, UFDF unit ops) Knowledge of purification processes/equipment; scale-up factors, process deviations, quality attributes. GMP experience is a huge plus.
Job Description:
Seeking a Process Development Engineer to join the Drug Substance Technology Engineering team at our Cambridge site. Providing strong process engineering/ technology transfer support of human therapeutic 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.
The Engineer will apply 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 purification 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
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
Top Must Have Skills: Downstream Process, Tech Transfer, Scale-up
Basic Qualifications:
Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience
Red Flags: Predominant Upstream, Analytical or Drug Product experience
Interview process:
1on1 teams and Panel interview.
We invite qualified candidates to send your resume to resumes@3keyconsulting.com. 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 www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.