Senior Associate Process Development Engineer II / Process Development Engineer

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Summary:

The incumbent will provide technical and scientific expertise to the development, scale-up, transfer, and/or support of production processes for plasma derived proteins.  Activities are centered on purification unit operations such as precipitation, filtration, chromatography, tangential flow filtration, formulation, nanofiltration, and process troubleshooting.

 

Primary Responsibilities:

• Supports developmental projects, manufacturing support projects, clinical manufacturing, and commercial manufacturing.
• Identifies or assists in developing action plans to support departmental goals and supports the execution.
• Prepares procedures and technical reports, including data analysis and interpretation.
• Prepares and/or reports technical results in internal and cross-functional team settings.
• Develops solutions to complex technical problems within area of expertise.
• Designs and executes scientifically rigorous experiments including the interpretation of results.
• Ability to execute experiments independently and in a team setting which may include the ability to direct others and lead study execution.
• Conducts laboratory and clinical production work using standard processing and analytical equipment.
• Identifies and collects data on critical process attributes and/or critical parameters for scaling.
• Supports the start-up and commissioning of equipment as well as implementation of new raw materials on-site.
• Supports the maintenance of the clinical manufacturing facility to cGMP standards.
• Maintains laboratory and clinical manufacturing facilities in accordance with departmental procedures.

 

Knowledge Skills and Abilities:

• Possesses the ability to set and meet deadlines, multi-task, and prioritize personal objectives based on project needs.
• Exhibits the ability to adapt to a changing work environment.
• Must have experience in technical writing, which may include laboratory notebook maintenance, and effective oral communication skills.
• Applies scientific or engineering principles in problem solving.
• Must have experience working at various process scales ranging from bench to pilot scale.
• Has knowledge and experience working in a GMP environment.
• Considerable knowledge in area of specialization (i.e. chromatography, filtration, etc.) and/or takes initiative to stay current and expand knowledge base.
• Must be self-motivated and able to work effectively in a matrixed organization.
• Must be proficient in use of MS Office Suite.

 

Location: Clayton, NC

Shift: Day

 

Education and Experience:

Bachelor’s degree in a relevant science or engineering field with 7+ years of relevant work experience, Associates Degree with 9+ years of experience or an equivalent combination of education and experience

 

Occupational Demands For Engineer: 

Work is performed in a clinical and/or a laboratory environment. Exposure to biological fluids wit