Principal Process/Specialty Engineer
Job
Overview
Greenville South Carolina
- Process and Technology
- Permanent
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To be Considered Candidates:: Must be authorized to work in the country where the position is located.
Job Description The purpose of this position is to provide technical expertise in multiple areas of Process Technology. The role leads other engineers in executing project assignments and may oversee several teams of engineers.
• May lead a process team on a project overseeing design of several process areas or units to develop drawings and specifications for study, feasibility, Front End Engineering Development (FEED), or Engineering, Procurement, Fabrication, and Construction (EPFC) for these units/systems
• Develop Process Technology Quality and Activity Plans for moderate to intermediate size projects
• Propose/develop cost effective work processes (project specific) to ensure client's success
• Provide execution support in the implementation of the Project Execution Plan
• Perform inspections and audits of activities to determine conformance to specified requirements
• Execute client's scope of work according to contract requirements
• Other duties as assigned
Basic Job Requirements • Accredited four (4) year degree or global equivalent in Chemical Engineering, Biochemical or
Bio Engineering and sixteen (16) years of work-related experience; a recognized professional certification or registration in the applicable field, if required; some locations may have additional or different qualifications in order to comply with local requirements
• Ability to communicate effectively with audiences that include but are not limited to management, coworkers, clients, vendors, contractors, and visitors
• Job related technical knowledge necessary to complete the job
• Ability to learn and apply knowledge of applicable local, state/province, and federal/national statutes and guidelines
• Ability to attend to detail and work in a time-conscious and time-effective manner
Other Job Requirements Experience in process engineering in Pharmaceuticals or Manufacturing with EPC or operating company.
Preferred Qualifications • Experience with cell culture, purification, harvest, downstream and upstream
• Hands on experience with FAT or facility startup
• Experience with plasma fractionation (centrifugation & filter presses), protein purification (both stainless steel and single use), formulation, fill & finish, clean utilities (WFI, Clean Steam, Clean gases, CIP design) and ethanol recovery.
• Experience with small scale monoclonal antibody and antibody drug conjugate production (both drug substance and drug product.
• Experience with single use system (bioreactors, single use mix systems, chromatography system, tangential flow filtration systems, viral filtration, and depth filtration), handling cyotoxic materials, formulation, fill & finish, and clean utilities (WFI, Clean Steam, Clean gases, CIP/SIP design).
• Experience with large scale bulk drug substance manufacturing of monoclonal antibodies and antibody like proteins.
• Experienced with large scale bulk drug substance manufacturing of monoclonal antibodies and antibody like proteins.
• Experience with Cell Culture, harvest downstream, upstream, Protein Purification, Clean Utilities (WFI, Clean Steam, Clean gases, CIP/SIP design).
• Experience with small scale single use manufacturing of non-antibody proteins.
• Experience with single use mix systems, chromatography system, tangential flow filtration systems, viral filtration, and depth filtration.
• Experience with blood plasma products. Experience with plasma fractionation (centrifugation & filter presses), protein purification (both stainless steel and single use), formulation, fill & finish, ethanol recovery.
• Experience with small scale monoclonal antibody and antibody drug conjugate production (both drug substance and drug product.)
• Experience with handling cyotoxic materials
• Experience with cell & gene therapy.
• Experience with Life Sciences, Pharma or Biologics
Degree Required Yes
City (or Nearest City) Morrisville
State/Province North Carolina
Country United States
Location Type Office
We are an equal opportunity employer that recognizes the value of a diverse workforce. All qualified individuals will receive consideration for employment without regard to race, color, age, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, genetic information, or any other criteria protected by governing law.
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