Job Description

Job Title: Engineer, Biopharma Upstream Process/Equipment Support (JP13874)
Location: Thousand Oaks, Ca 91320
Employment Type: Contract
Pay Rate: $38.00 - $42.00/hour W2 with benefits
Business Unit: AMA Pilot Plant
Duration: 12 months with likely extensions and/or conversion to permanent
Posting Date: 03/28/25
Notes Candidate will be required to be on site 3-4 days a week and may work remotely 1-2 days a week (activities permitting).

Must have biotech background/experience, plus must have cell culture/purification experience.

3 Key Consulting is hiring! We are looking for an engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

The ideal candidate for the upstream engineer role is an early-career professional with a bachelor’s degree and 2 years of industry experience, or a recent master’s graduate, preferably in chemical engineering, biochemical engineering, or biology. They must have hands-on experience with mammalian cell culture (not fermentation), bioreactors, and upstream cell culture equipment, along with a strong biotech industry background. The candidate should be comfortable analyzing manufacturing data and presenting findings to cross-functional teams, including directors and large groups of manufacturing staff (20+). Strong communication and presentation skills are essential. While familiarity with downstream/purification processes is a plus, it is not required. Candidates must be able to work onsite 3–4 days per week in Thousand Oaks. Red flags include a pure chemistry background without relevant lab experience and weak communication abilities.

Seeking a Process Development Engineer to join the Drug Substance Technology Engineering team at our Thousand Oaks facility. Providing process engineering support for 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 cell culture and/or purification process engineering knowledge in support of technology transfer and clinical/commercial drug substance manufacturing in an innovative manufacturing suite using single-use technology. Will partner with manufacturing, quality, analytical, and bench scientists to support a highly dynamic manufacturing facility.
Job Responsibilities:

Under guidance of senior staff, the Engineer performs the following:

Transfer cell culture and/or purification drug substance processes and perform process improvements from the laboratory into the manufacturing facility
Provide technical support for successful scale-up, transfer of process technology, and for clinical and/or commercial manufacturing operation
Offer process validation support for late-stage commercial processes
Provide routine process monitoring and troubleshooting
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

PREFERRED QUALIFICATIONS:

Bachelor degree Chemical or Biochemical Engineering and 2 years of experience GMP Environment
1+ years of Process Engineering experience preferably related to scale-up principles and commercial cGMP manufacturing facilities
Background in biologics tech transfer into commercial facilities
Cell culture and/or Purification process knowledge:
Knowledge of purification processes/ equipment; scale up factors from chromatography, UF/DF, process deviations, raw materials to growth and quality attributes
Knowledge of cell culture processes/ equipment; scale up factors from, mass oxygen transfer capabilities impact of metabolism, process deviations, raw materials to growth and quality attributes
Strong capability of analysis, troubleshooting and problem solving
Ability to develop and follow detailed protocols
Independently motivated with ability to multi-task and work in teams
Excellent written and verbal communication skills with technical writing and presentation experience

Top Must Have Skills:

Specifically looking for upstream experience
Strong communication - must be comfortable speaking to a group of 20+ manufacturing associates in presentation (data reviews/etc.)
GMP experience highly preferred (Looking for GMP background/ someone who has dealt with FDA/ inspectors/ auditors)

Day to Day Responsibilities:

•   Ensure preventative maintenance is performed on equipment

•   Coordinate and organize project work

•   Support continuous improvement projects

Red Flags:

Education purely in chemistry without relevant biology/engineering experience
Experience only in downstream/purification without upstream relevance
Lack of communication skills
Inability to summarize technical data
Candidates not comfortable with onsite needs
Pure chemistry background without relevant bio/eng lab experience

Weak presentation abilities

Interview process:
Phone screen followed by in-person or video panel interviews.

We invite qualified candidates to send your resume to recruiting@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.

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

Website

3keyconsulting.com

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