Manufacturing Project Specialist
Our client is seeking a Manufacturing Specialist! Our client is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of their dedication to building and empowering their internal teams, our client is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, they deliver deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics and cell and gene therapies. They forge exceptionally strong partnerships with their clients, and they never lose sight of their pledge to deliver a reliable and compliant drug substance supply, Right, On time. This is a direct hire opportunity with excellent benefits and a competitive salary!
Support the implementation of new processes in close collaboration with our Process Transfer and Process Development teams.
Lead cross training activities and transferring those skills across manufacturing facilities by training new hire employees.
Ensure process optimization and continuous improvement.
Identify new technology for new/current assets and assist with identifying user requirements, procurement, and implementation as needed.
Collaborate with engineering and validation teams to implement and qualify new equipment and controls.
Author and update quality documents, such as Standard Operating Procedures (SOPS) and other technical procedures.
Follow-up on production campaigns including client communication, review and approval of batch records, troubleshooting, handling of deviations and CAPAs.
Execute Upstream Mammalian Cell Culture including Cell Expansion production activities
Execute Downstream processes including AKTA Bioprocess chromatography systems and large-scale column packing.
Lead troubleshooting activities on bioprocess operations and acts as SME for floor operations.
Oversee compliance and technical development projects.
BA/BS degree in a science related discipline preferred or combination of education and work experience.
8+ years’ experience in bioprocessing manufacturing, preferably in large-scale operations.
Expertise in GMP and bioprocessing knowledge.
Expertise assembling, disassembling, operating and understanding complex equipment and processes.
Experience with the installation and qualification of production equipment.
Knowledge of Aseptic Techniques and adherence to cGMP practices.
Strong knowledge of algebraic math skills and computer aptitude.
Experience with Single Use Technology systems.
Detail- oriented with the ability to complete written and verbally assigned tasks following specific procedures.
Must be highly motivated and self-driven.
Demonstrated ability to work independently and multitask under aggressive timelines to support department and company objectives.
Ability to interact constructively with and influence peers and support groups.
Ability to effectively communicate ideas through verbal and written forms.
Ability to lift up to 50 pounds and to wear and work in clean room garments.
VanderHouwen is an award-winning, Women-Owned, WBENC certified professional staffing firm. Founded in 1987, VanderHouwen has been successfully placing experienced professionals throughout the Pacific Northwest and nationwide. Our recruitment teams are highly specialized in either Technology and IT, Engineering, or Accounting and Finance career markets. Our recruiters value building meaningful, professional relationships with each candidate as well as developing honed knowledge of companies' staffing needs and workplaces. Partner with us to land your next exciting career.
VanderHouwen is an Equal Opportunity Employer and participates in E-Verify. VanderHouwen does not discriminate on the basis of race, color, religion, sex, national origin, age, disability, or any other characteristic protected by applicable local, state or federal civil rights laws.