We are seeking a Process Validation Engineer III to join our Manufacturing and Sciences Department in Gaithersburg, MD. Qualified individuals will play a leading role on for performing a wide range of process validation activities under general supervision as per applicable company procedures and regulatory guidance. Responsibilities may include, but are not limited to, leading and supporting PPQs, resin and membrane lifetime studies, CPV, mixing studies, media fills, and other projects. We are looking for candidates with either cell culture (upstream) or protein purification (downstream) experience. The candidate will collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. This role will be critical in ensuring establishment of robust processes across multiple locations meeting critical deliverables.
Responsibilities include but are not limited to:
- Partner with development and development-to-launch teams for strategic alignment of cleaning studies, hold times, and revalidation/qualification activities for our manufacturing sites.
- Partner with manufacturing, QA, and technical transfer teams to resolve all deviations encountered during project and protocol execution.
- Create and write validation protocols, directives, SOPs, and reports as required and review for technical validity.
- Review change requests for impact to validation and support QA. compliance activities such as Product Quality Review.
- BS in Biochemistry, Microbiology, Biology, or closely related field, and more than 5 years relevant industrial experience. MS preferred.
- Biologic/Vaccine manufacturing experience is required. Multi-year industrial purification experience with approved vaccines/biologics is preferred; direct experience with virus-derived recombinant products and/or viral particles is a plus.
- Capable of performing multiple functions in a fast-paced environment. Strong technical protocol/report writing and good organization skills are required.
- Strong understanding of FDA regulatory requirements associated with analytical characterization and documentation of vaccine products.
- Diverse knowledge and experience in various relevant areas, including but not limited to molecular/cell biology, harvest, formulation and common analytical tools is preferred.
- Excellent record keeping abilities to adequately record, analyze and document data generated in support of regulatory requirements.
- Demonstrated verbal and written skills in communicating scientific and technical information.
- Proficient in Window based software including Excel, PowerPoint and Word.