Process Development Engineer

Entegee; Thousand Oaks (CA); On-site; USD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a dedicated professional to provide technical support for drug product process development. This role involves collaborating with cross-functional teams to enhance efficiency in commercial manufacturing operations. You will troubleshoot processing technologies, author technical documents, and contribute to the transfer of innovative technologies to commercial sites. If you have a background in Chemical or Biomedical Engineering and possess a passion for pharmaceuticals, this opportunity offers a chance to make a significant impact in a dynamic environment.

Qualifications

• 3+ years of experience in drug product process development in pharmaceuticals.
• Hands-on experience with liquid and lyophilized drug products.

Responsibilities

• Provide technical support for drug product process development.
• Collaborate with manufacturing for commercial drug product operations.
• Troubleshoot issues with processing technologies and equipment.

Skills

Technical Support

Process Development

Troubleshooting

Data Analysis

Education

Degree in Chemical/Biomedical Engineering

Degree in Pharmaceutical Sciences

Degree in Chemistry/Biochemistry

Degree in Biotechnology

Job description

Provide technical support for drug product process development, including formulation, filtration, filling (vials/syringes/devices), and lyophilization of parenteral products.

Assist in the development and characterization of drug product processes and the transfer of new technologies to commercial sterile fill/finish sites.

Support process development for commercial drug product processing in areas such as sterile processing, process characterization, tech transfer, and validation.

Collaborate with manufacturing and support functions to provide coordinated support for commercial drug product manufacturing operations and technology transfer.

Participate in global cross-functional teams, working effectively in a highly matrixed team environment to drive efficiency and foster strong relationships.

Troubleshoot issues with drug product processing technologies and equipment, utilizing data-driven analyses and visualizations to determine true root causes.

Author and review guideline documents, technical protocols, reports, product impact assessments, and regulatory submissions.

Preferred Qualifications:

• Degree in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry, Biotechnology, or a related field.
• 3+ years of drug product process development experience in the pharmaceuticals/biotechnology industry.
• Knowledge of and hands-on experience with end-to-end development for liquid and lyophilized drug products in various presentations.

Seniority level

Associate

Employment type

Full-time

Job function

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