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Want to take your knowledge and experience further? Ready to provide technical leadership and make key decisions? This is your opportunity - not only to join a committed, professional, and forward-thinking team but also to lead in the design and implementation of sophisticated manufacturing processes and transform broad concepts into structured results-focused projects.
Join a growing team with this new opportunity for a Project Engineer at our Frederick, Colorado GMP facility. Work in our multifaceted, fast-paced, API-Biopharma manufacturing environment with the ability to contribute to the growing industry of oligonucleotide (DNA-RNA) based therapeutics.
Duties and Responsibilities include:
- Responsible for small to large-sized capital projects throughout all phases of the project lifecycle, including the development of user requirement specifications, process design, equipment and instrumentation specification/selection, equipment procurement, installation, commissioning, qualification, and turn-over to manufacturing.
- Responsible for project management aspects including project schedule, budget, and coordination of multi-disciplinary teams.
- Support Project Team and Facilities/Engineering Team with day-to-day troubleshooting and maintenance activities, identification of process improvement and optimization opportunities, review of SOP, and CMMS Assets.
- Provide support and serve as SME for unit operations such as Tank Farm, Process Utilities, and unit operations as needed or advised.
- Provide build-out of CMMS for small and large capital processes.
- Support EHS activities including PHA, PSSR, Permitting, and PSM compliance.
- Support Validation activities including review of Factory Acceptance Test and Site Acceptance Test (FAT/SAT) protocols and participating in FAT/SAT execution, review of installation, operational, and performance qualification (IQ/OQ/PQ) protocols, participating in IOPQ execution, and review of final reports.
- Support Quality Assurance activities including writing, review, and/or resolution of Change Controls (CC/CSC), Corrective and Preventive Actions (CAPAs), and audit responses.
- Perform job functions and responsibilities independently and with limited direction.