Principal Bioprocess Engineer
1 month ago
No Deviation is a provider of patient-centric solutions for the pharmaceutical industry, focusing on innovative engineering consultancy and quality-driven services.
Estimated Salary Range: $120,000 - $180,000 per annumJob Description:We are seeking an experienced Principal Bioprocess Engineer to join our team, utilizing your expertise in biopharmaceutical processes to drive project success. Key responsibilities include technical leadership, site selection assessment, equipment validation, and process optimization.
- Lead and participate in technical transfer activities and cross-functional meetings.
- Work independently and/or with project managers to complete engineering projects within schedule, budget, and quality constraints.
- Responsible for commissioning and qualification activities, including FAT, SAT, PSSR, automation checkouts, IQ, OQ, PQ, and asset/preventive maintenance/spare parts creation for new process equipment.
To succeed in this role, you will need:
- A Doctorate degree in Engineering or Master's degree in Engineering with 4 years of directly related experience in a pharmaceutical manufacturing site.
- Bachelor's degree in Engineering with 8 years of directly related experience in a pharmaceutical manufacturing site.
- Proven experience in managing various stakeholders' expectations related to process equipment in biopharmaceuticals.
- Strong analytical skills and knowledge of industry trends to identify potential improvement opportunities.
- Working knowledge of biopharmaceutical processes such as chromatography, buffer/media tanks, viral filtration, tangential flow filtration.
- Experience in validation processes such as generation/execution of Installation/Operation/Performance qualification documentation.
- Demonstrated project management skills (schedule/cost development, facilitation, collaboration, basic project management, completion, and follow-up).
This position offers the chance to work in a collaborative, innovative environment that fosters personal growth and development. As a Principal Bioprocess Engineer, you will have the opportunity to make a meaningful impact in the pharmaceutical industry while advancing your career.
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