The Spear Group · 20 hours ago
Process Engineer
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Responsibilities
Demonstrates a strong understanding of GMPs and provides Process Engineering and Project Engineering support End to End in highly regulated pharmaceutical facilities. Candidates should have demonstrated experience with drug substance / bioprocessing manufacturing processes.
Apply biopharma innovative enthusiasm and bioprocessing technical skills as a member of a multidisciplinary team.
Design and Startup qualification.
Design, startup and qualification of Fermenters, Bioreactors, Downstream purification.
Utilize single use technology.
Challenge traditional practices to make way for innovative/creative solutions. Process improvement focus.
Support the manufacturing of product engineering and validation lots.
Support technical investigations.
Support commissioning and qualification of new equipment.
Support regulatory submissions.
Drive process/business system improvements.
Qualification
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Required
Bachelor of Science Degree in engineering – chemical engineering, biomedical engineering, mechanical engineering, biological engineering, biochemical or biomolecular engineering, or any related engineering major.
3-15 years of experience with drug substance process engineering.
Experience with design and startup qualification.
Experience with the design, startup and qualification of Fermenters, Bioreactors, Downstream purification.
Experience with utilizing single use technology.
Experience challenging traditional manufacturing practices to make way for innovative/creative solutions.
Experience impacting process improvement.
Experience supporting the manufacturing of product engineering and validation lots.
Experience supporting technical investigations.
Experience with the commissioning and qualification of new equipment.
Experience supporting regulatory submissions.
Experience with driving process/business system improvements.
Extensive experience with GMP.
Company
The Spear Group
The Spear Group is a provider of quality, experienced project controls, owners representation and project management services.
H1B Sponsorship
The Spear Group has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (2)
2022 (1)
2020 (1)
Funding
Current Stage
Growth StageCompany data provided by crunchbase