3 Key Consulting, Inc.

Process Development Engineer, upstream drug substance (JP13223)

3 Key Consulting, Inc.  •  $42/hr  •  Thousand Oaks, CA (Onsite)  •  17 days ago
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Job Description

Job Title:  Process Development Engineer, Upstream Drug Substance (JP13223)
Location: Thousand Oaks, CA. 91320
Business Unit: Drug Product Development Manufacturing
Employment Type:  Contract
Duration: 1+ years with possible extension or conversion to FTE
Rate $38 - $42 / hr.
Posting Date: 9/24/2024
Notes: On site minimum 3 days per week. Specifically looking for upstream experience.

3 Key Consulting is hiring!  We are recruiting an  Engineer for a consulting engagement with our direct client, a leading global biotechnology 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 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.

* onsite a minimum of 3 days a week

**Must have biotech background/experience, plus must have cell culture and/or purification experience


Top Must Have Skill Sets:
  • Specifically looking for upstream purification 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:
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 collaborate with other functions such as Manufacturing, Quality, and Regulatory

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
  • 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)

Why is the Position Open?

Supplement additional workload on team.

Interview Process:

Phone/ Webex

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.


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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