Lead HPLC Engineer - R&D to Manufacturing (Direct Hire)
Job Requisition: 6846
Description for Lead HPLC Engineer:
This role will involve designing, fabricating, and running HPLC equipment to support experimental design and execution of small scale and production scale chemical processes for Active Pharmaceutical Ingredient (API) process development and API manufacturing process improvement.
This role will also lead efforts for production equipment design to include scale up from development to full scale manufacturing. This is a fast-paced product development cycle to help cure some of life-threatening forms of cancer and is looking for team members that fit well into this environment.
Someone with an R&D or process engineering background OR analytical chemistry background using HPLC may work; alternatively, a HPLC specialist may also be considered.
Responsibilities for Lead HPLC Engineer:
- Design, fabricate/procure, install, and operate preparative HPLC equipment
- Collaborate with multiple process development teams to support translation of small-scale HPLC-based processes to design requirements and specifications for full-scale production systems and processes
- Collaboratively develop equipment and process commissioning plans
- Lead start-up and commissioning of HPLC equipment and processes
- Troubleshoot equipment problems and develop corrective actions
- Collaboratively develop and execute equipment qualifications (IQ, OQ, PQ)
- Develop SOPs, batch records, and technical documents
- Some travel may be required
Requirements for Lead HPLC Engineer:
- Experience designing, fabricating, and running HPLC equipment (Preparative HPLC equipment experience a BIG plus)
- BS in Chemical/Mechanical/Nuclear Engineering, Chemistry, Radiochemistry or Physics with relevant experience
- Demonstrated experience with manufacturing within FDA GMP regulatory requirements is highly desired.
- Willingness to learn and understand new technology, instrumentation and technical processes
- Ability to read from engineering drawings or schematics
- Ability to follow written procedures and accurately record test data
- Ability to work safely within an industrial and radiation environment
- Experience or knowledge of nuclear process equipment and instrumentation a plus