Senior Engineer, Biotech Single Use

Job Title:Senior Engineer, Biotech Single Use
Location:Thousand Oaks, CA.
Employment Type: Contract
Duration:1+ year(s) (with possible extensions)
Rate
: $45 - $50/hour W2
Posting Date:05/10/2024

3 Key Consulting is recruiting a Senior Engineer
for a consulting engagement with our direct client, a leading global biotechnology company.

Summary:
In this vital role, you will be part of the Drug Substance Technology and Engineering group within the Process Development organization. One of the primary responsibilities will be providing technical leadership for Single Use components and assemblies. In this role, you will also introduce new technologies to the network and will be supporting investigations of clients’ global manufacturing.

Responsibilities:

• Support of Single Use network in terms of design and investigation
• Use process engineering and equipment design experience, to assess unit operation performance and work with both suppliers and the internal network to resolve equipment and single use consumable challenges.
• Analyze available data, research technical subjects, and work with other subject matter experts to support resolution of critical investigations.
• Provide leadership on capital projects.
• Provide process development representation on capital projects, ensuring process requirements are incorporated into equipment and facility designs.
• Support and/or lead design of flexible manufacturing equipment and single use consumables, including support of factory acceptance testing and onsite commissioning and qualification.
• Support the client’s single use global network as a drug substance domain expert.

Top 3 Must Have Skill Sets:

• Background in Single Use Technologies
• Background in Process Engineering
• Project management skills
• Validation experience

Basic Qualifications:

• High school diploma/GED and 12 years of Engineering or Operations experience OR Associate’s degree and 10 years of Engineering or Operations experience OR Bachelor’s degree and 5 years of Engineering or Operations experience OR Master’s degree and 3 years of Engineering or Operations experience OR Doctorate degree

Preferred Qualifications:

• Master’s degree and 6+ years of directly related experience, or PhD with 2+ years of directly related experience
• Strong understanding of GMP equipment design and biologics manufacturing requirements
• Detailed knowledge of multiple unit operations
• Experience leading root cause analyses and solving GMP manufacturing issues
• Ability to apply sophisticated problem solving skills within defined constraints
• Experience providing process engineering support of pilot/clinical/commercial processes

Interview Process:
One phone and one virtual panel interview.

We invite qualified candidates to sendyour resume to. Ifyou decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our  You are also welcome to sharethis opportunity with anyone you think might be interested in applying for this role.
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