Process Development Engineer

Summary: Seeking a Process Development Engineer with experience in biotech, cell culture, and purification processes for process improvement and technical support roles.

Job Requirements:

• Bachelor's degree in Chemical or Biochemical Engineering and 2 years of experience in 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.

Preferred Skills:

• Experience working with cell culture bioreactors - monitoring of at-scale bioreactor process/equipment.

• Experience with Purification processes/equipment; chromatography, UF/DF Ultra filtration, Dia filtration.

• Experience working in a GMP plant and quality systems.

Job Responsibilities:

• Transfer cell culture and/or purification drug substance processes from the laboratory into the manufacturing facility

• Perform process improvements

• Provide technical support for successful scale-up, transfer of process technology, clinical/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.

 

 Pay: 27-36

Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client.

 

 

Pay Details: $27.00 to $36.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

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The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.