Job Description
Searching for a Process Engineer with experience in pharmaceutical drug product manufacturing, specifically in the areas of sterile injectable product formulation and filling, barrier system technology, and single-use fluid path components. The Petersburg, VA facility, which is nearing completion, will be the first generic drug product facility in the US to use all isolator-style high-speed filling lines.
During the project phase, you will primarily manage OEMs and engineering services providers through commissioning, qualification, and validation and lead process development for two recently installed high-speed filling lines and one future line dedicated to Affordable Insulin . During the operational phase, you will be the System Owner/SME of a high-speed filling line, optimizing equipment uptime and process robustness as we continue to transfer products currently produced by contract manufacturing sites, fulfilling our mission to “Do what’s in the best interest of patients.”
Basic Qualifications (knowledge, Skills, And Abilities)
- Bachelor’s degree in engineering, Materials Science, Biology, or related discipline.
- Minimum 4+ years working in a cGMP environment, i.e. pharmaceutical, medical device, or food and beverage manufacturing
- Exposure to parenteral processing equipment and operations, including formulation, filling, visual inspection, and packaging equipment.
- Front-line support of aseptic filling equipment and/or barrier systems, e.g. isolator or RABS.
- Demonstrated ability to solve technical problems and implement projects.
- Excellent interpersonal and communication skills across various levels of the organization.
- Strong Mechanical Aptitude.
- Interact with other functions (e.g. Manufacturing, Automation, Quality Assurance, R&D) and must be able to take ownership of and follow through on assigned projects.
- Ability to execute on-the-floor activities such as FAT, SAT, IQ/OQ, and Engineering batches.
- Willingness to adapt to changing priorities as project demands change.
- Ability to explain complex technical issues to external customers/agencies.
Preferred Qualifications
- SME-level knowledge of high-speed aseptic filling and barrier system technology (isolator, RABS).
- Expertise in single-use components in drug product formulation, sterile filtration, and aseptic filling applications.
- Demonstrated management and delivery of large capital projects ($1MM +).
- Experience with greenfield facility Commissioning, Qualification, and Validation (CQV) and production startup desired.
Comprehensive relocation package is offered.