Principal Engineer - Filling, Labeling, Packaging, Bulk, HPLC and Synthesizer

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:

This position will be a member of the Manufacturing Technical Support team in San Diego, responsible for technical leadership and support of routine manufacturing of products for diagnostics. The individual assures continuous improvement and equipment reliability of the Filling, Labeling, Packaging, Oligosynthesis, Bulk and processes and will be assigned to several projects.

 

Grow with Grifols! This Individual Contributor may have 3 direct reports in the future. Which will mean, participation in human resources matters and responsibility for performance management in its area of responsibility.

 

Project work: The individual will lead their own projects as well as oversees Engineers working on projects. They will work in projects groups with Manufacturing Scientists, Manufacturing, Quality & Validation. Typically, large capital projects and contentious improvement projects.

Equipment: The Principal Engineer will work on both older and state-of-the-art equipment (automated, visual system, cameras). In our manufacturing plant they will be working on Filling- , Labeling-, Packaging-, Bulk-, HPLC and Synthesizer ( for Oligosynthesis: AKTA Oligo Pilot) equipment.

 

The team is looking for: Engineer with a strong background in Mechanical and Electrical Engineering with at least a bachelor’s degree and 8 years of work experience and strong project management skills.  Hands on experience with Filling & Labeling equipment makes you a top candidate for this position. Knowledge in automation engineering as well as HPLC”, Oligosynthesis is a plus.

 

Primary responsibilities for role:

• Leads projects and troubleshooting efforts involving Filling, Labeling, Bulk, High Performance Liquid Chromatography "HPLC", Oligosynthesis (AKTA Oligo Pilot) and Packaging equipment and clean utilities systems.
• Ensures compliance with company and regulatory policies and procedures and is responsible for optimum use of staff and technical capabilities within defined areas.
• Focuses on fostering a best-in-class environment for the development, manufacture, and regulation of biological products through availability and analysis of data, process understanding and Critical Quality Attributes (CQAs), utilization of process capabilities (maximize yield and throughput within CQA), continuous quality verification and continuous improvement.
• Develops technical engineering standards. Resolves conflicts within areas of responsibility.
• Serves as a consultant to management within specified area.
• Advances technical project proposals to senior management following through to successful completion. Chairs inter / intra-departmental teams.
• Interacts frequently with senior technical peers. Sets levels of standard technical performance for others. Utilizes flexible leadership skills.
• Influences commitment of resources at division/department level.
• Makes independent decisions within defined areas of responsibility.
• Provides technical/non-technical report status on budgets and schedules.
• After hours support may be required. (On-Call)

 

Additional Responsibilities

Implementation of efforts that evaluate the feasibility of online instruments to monitor key critical attributes, performance of proof-of-concept studies on new applications and identification of opportunities to optimize current processes. Identifies new process analytical opportunities in cooperation with Business Units, Technology, QO and Bio-Analytic. Supports business case development and testing of analyzers. Leads installation, qualification, and integration into process controls. Develops objectives and implementation plans for a te