Engineer, Manufacturing Engineer

ApTask Global Workforce (AGW) is seeking an Engineer with a technology company. This is a 12+ month contract opportunity with our client located in Thousand Oaks. This is a remote position

Summary:

This role will join the Drug Substance Technology Engineering team, providing strong process engineering and technology transfer support for human therapeutic products from clinical development through commercial production. The Engineer will apply process engineering knowledge to support upstream and/or downstream technology transfer and manufacturing in both stainless and single-use formats, partnering with manufacturing, quality, analytical, and bench scientists.

Responsibilities:

• Transfer 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 collaborate with other functions such as Manufacturing, Quality, and Regulatory

Requirements:

• Master's degree
• OR Bachelor's degree and 2 years of Engineering or Operations experience
• 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
• At least 2 years of Biologics / Drug Substance tech transfer experience required (Cell culture/ harvest/ Chromatography/ filtration/ UFDF unit ops)
• At least 2 years of experience in lab scale development work or in a manufacturing environment (pilot plant or GMP)
• Strong analytical capability, troubleshooting, and problem solving skills

Desired skills:

• Master's Degree in Chemical or Biochemical Engineering
• 1+ years of Process Engineering experience preferably related to upstream and/or downstream purification of commercial cGMP manufacturing facilities
• Background in biologics technology transfer into commercial facilities, new product introductions (NPIs)
• Knowledge of processes (cell culture, harvest, chromatography, viral filtration/inactivation, ultrafiltration/diafiltration, and final fill) and equipment
• Independently motivated with ability to multi-task and work in teams
• Excellent written and verbal communication skills with technical writing and presentation experience

Pay range: Up to $42.52 per Hour

Only candidates available and ready to work directly as ApTask Global Workforce (AGW) employees will be considered for this position.

If you have the described qualifications and are interested in this exciting opportunity, please apply!

ApTask Global Workforce (AGW)

ApTask Global Workforce (AGW) is a certified Minority and Veteran workforce solutions company. AGW delivers operational, clinical, lab and professional talent with a strong focus on healthcare and life sciences. The company supports clients with reliable staffing, program expertise and a commitment to quality, speed and consistent delivery.

Benefits of working with ApTask Global Workforce include:

• Medical
• Dental
• Vision
• Sick Pay (for applicable states/municipalities)

Our team stays close to the process and is here to guide you every step of the way. To learn more, please visit our website

ApTask Global Workforce is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran.