Engineer, Drug Product Manufacturing Process Development (JP14993)

3 Key Consulting • Thousand Oaks, CA

23h • Onsite

About The Position

We are seeking a skilled Process Development Engineer who can work independently to support technical projects. The ideal candidate will have expertise in laboratory testing, drug product fill finish processing, holistic drug product process knowledge, technical transfer, and drug product manufacturing. Excellent communication skills and proficiency in technical writing are essential for this role. The Process Development Engineer will: Author, data verify, and review guideline documents, technical protocols, reports, product impact assessments. Execute laboratory analytical testing such as: viscosity, protein concentration, pH, osmolality. Execute laboratory experiments such as pipetting, formulation, filtration. Provide technical support for drug product process development, including formulation, filtration, and filling (vials/syringes/devices) 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.

Requirements

• Post graduation experience required
• Laboratory experience using analytical equipment
• Evidence of good communication e.g. writing documents and sharing results
• College degree in engineering or similar (chemical engineer, bio engineer, pharmaceutical science, etc)
• 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

Responsibilities

• Author, data verify, and review guideline documents, technical protocols, reports, product impact assessments.
• Execute laboratory analytical testing such as: viscosity, protein concentration, pH, osmolality.
• Execute laboratory experiments such as pipetting, formulation, filtration.
• Provide technical support for drug product process development, including formulation, filtration, and filling (vials/syringes/devices) 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.

What This Job Offers

• Career Level: Entry Level