3 Key Consulting, Inc.

Process Engineer – Biotech Downstream/Tech-Transfer (JP14390)

3 Key Consulting, Inc.  •  $41/hr  •  Cambridge, MA (Hybrid)  •  4 months ago
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Job Description

Job Title: Process Engineer – 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.



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.

3 Key Consulting, Inc.

About 3 Key Consulting, Inc.

3Key Consulting specializes in the rapid recruitment and placement of business and IT professional within the life sciences and healthcare industries. With 12 years of experience, 3Key has established a vast network of industry professionals and forged strong partnerships/alliances with key academic institutions across the country to continually develop our business professional and niche skill pipeline.

3KC offers a full suite of staffing solutions including PEO and compliance services. 3KC has several technology and industry domain practices including competencies in business intelligence, healthcare and life sciences.

People, process, and technology are 3 key areas of focus that we carefully examine individually and jointly, in order to deliver on our client's 3 key areas of focus - better, faster and cost effective BI and staffing solutions.

MISSION:

To create a better work experience for our customers, partners and employees through exceptional dedication and performance.

• We make hiring easier

• We build strong teams

• We bring about positive outcomes

VISION:

3 Key Consulting’s responsibility is to continually improve the manner and efficiency in which human resources and businesses are brought together to create value. Our vision is to put programs into action that improve market efficiencies while helping businesses and people be more productive.

Industry
Unknown
Company Size
1-10 employees
Headquarters
Simi Valley, CA
Year Founded
2009
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