US Tech Solutions
Engineering Associate Director
US Tech Solutions, Holly Springs, North Carolina, United States, 27540
Overview
Duration: 9 months contract. Remote-welcome with travel up to 25% to Holly Springs, NC. Job Summary
Highly versatile and experienced subject matter expert who can contribute as an individual or lead teams across a wide range of drug substance technical areas. Responsible for aspects of Technology Transfer, Process Scale-up, Clinical & Commercial Manufacturing Support, and Process Performance Qualification (PPQ) during the start-up of a new Drug Substance production facility. Also responsible for enabling CMC regulatory file drafting and support, commissioning and qualification of equipment, utilization of process models, process characterization, and process optimizations and troubleshooting. The qualified candidate will lead technical teams across various disciplines and objectives. Some examples of additional responsibilities: Work cross-functionally with individuals and project teams in Process Development, Manufacturing, Quality, and Facilities & Engineering; create and assess process technical assessments to support deviations and validations; create and execute project plans and schedules; develop, execute, and review technical documents, validation documents, specifications, development plans, characterization plans, and verification and validation plans; provide deep technical assistance for junior engineers. Must Required Skills
Broad expertise across Drug Substance (DS) with extensive experience including Technology Transfer, Process Scale-up, Clinical & Commercial Manufacturing Support, Process Performance Qualification (PPQ), CMC regulatory file drafting and support, commissioning and qualification of equipment, utilization of process models, process characterization, and process optimizations and troubleshooting. Experience at Principal Engineer or Director level in current role Strong technical and management skills; able to deliver as an individual contributor and as a team lead Strong collaboration skills with a track record of success in a team environment About US Tech Solutions
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit http://www.ustechsolutions.com. US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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Duration: 9 months contract. Remote-welcome with travel up to 25% to Holly Springs, NC. Job Summary
Highly versatile and experienced subject matter expert who can contribute as an individual or lead teams across a wide range of drug substance technical areas. Responsible for aspects of Technology Transfer, Process Scale-up, Clinical & Commercial Manufacturing Support, and Process Performance Qualification (PPQ) during the start-up of a new Drug Substance production facility. Also responsible for enabling CMC regulatory file drafting and support, commissioning and qualification of equipment, utilization of process models, process characterization, and process optimizations and troubleshooting. The qualified candidate will lead technical teams across various disciplines and objectives. Some examples of additional responsibilities: Work cross-functionally with individuals and project teams in Process Development, Manufacturing, Quality, and Facilities & Engineering; create and assess process technical assessments to support deviations and validations; create and execute project plans and schedules; develop, execute, and review technical documents, validation documents, specifications, development plans, characterization plans, and verification and validation plans; provide deep technical assistance for junior engineers. Must Required Skills
Broad expertise across Drug Substance (DS) with extensive experience including Technology Transfer, Process Scale-up, Clinical & Commercial Manufacturing Support, Process Performance Qualification (PPQ), CMC regulatory file drafting and support, commissioning and qualification of equipment, utilization of process models, process characterization, and process optimizations and troubleshooting. Experience at Principal Engineer or Director level in current role Strong technical and management skills; able to deliver as an individual contributor and as a team lead Strong collaboration skills with a track record of success in a team environment About US Tech Solutions
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit http://www.ustechsolutions.com. US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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