Job Description

Job Title Engineer, Biotech Process Engineering (JP10544)
Location: Thousand Oaks, CA 91320, (Hybrid, 2-3 days/week onsite)
Employment Type Contract to Hire
Duration 12 months with likely extensions or conversion to permanent
Job posting date 7/12/2022
Note: Hybrid position. Candidate will be required to be on site half the week and may work remotely 1-2 days a week. Must have biotech background/experience, plus must have purification experience.

3 Key Consulting is hiring an Engineer for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.

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 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 purification drug substance processes and performs 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

BASIC QUALIFICATIONS:
Master’s degree OR
Bachelor’s degree OR
Associate’s degree and 7 years of Engineering or Operations experience OR
High school diploma / GED and 8 years of Engineering or Operations experience

PREFERRED QUALIFICATIONS:
Master’s Degree in Chemical or Biochemical Engineering
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
Purification process knowledge:
- Knowledge of purification processes/ equipment; scale up factors from, chromatography, UF/DF, 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 Skill Sets

Must have biotech background/experience, plus must have purification experience.
Strong understanding of data analysis tools

Knowledge of biologics purification processes/ equipment; scale up factors from, chromatography

1+ years of Process Engineering experience preferably related to scale-up principles and commercial cGMP manufacturing facilities

Manufacturing experience must be biotech experience

Day-To-Day Responsibilities

Staff will perform tech transfer of early clinical candidate molecules. In addition, staff will support all processes (clinical and commercial) executed in the facility, performing process monitoring and responding to issues as appropriate

Red Flags

Multiple short duration jobs on resume
No purification experience - critical experience (Chromatography, purification, USTF)
Manufacturing experience - must be biotech experience

Interview Process:

Phone screen followed by Webex interview

We invite qualified candidates to send your resume to resumes@3keyconsulting.com If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com You are welcome to also share this posting 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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