Grifols Shared Services North America, Inc Engineer_MS&T in Emeryville, California
Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.
The process engineering team is tasked with improving the maturity, scale, and efficiency of manufacturing processes; driving key initiatives that include capacity expansion, process scale-up activities, site transfers, and critical pieces of new product introductions. The Engineer I will work with Scientists and Specialists within MS&T, partnering cross-functionally with R&D, Quality, Production and other engineering groups to develop processes for new products and sustain and improve processes for existing products within any one of the following Manufacturing areas: Fermentation, Purification, Bulk Fill or Technical Services
Primary responsibilities for role:
● Provide technical support for new products to site including process/equipment feasibility assessments, process and equipment requirements
● Support process improvements, engineering scale-up, investigational studies and onboarding and purchase of new equipment.
● Supports all QA Compliance investigations for process deviations, technical assessment of issues, root cause investigations, CAPA task management
● Ability to own and drive change control records for the department as required to support departmental projects and assigned CAPAs.
● Provides guidance to staff with production support activities including pre-production checks and equipment testing activities as required
● Prepares equipment related operating procedures and/or relevant engineering, including data interpretation and able to communicate technical results in cross-functional settings.
● Supports commercial manufacturing group for routine manufacturing processes
● Participates in projects associated with process equipment, process improvements, as well as design, start-up, commissioning, and qualification of new investments.
● Participates in evaluation of new technology and process equipment for introduction into GMP manufacturing.
● Supports process technology transfers from other depts.to increase the effectiveness of Manufacturing processes
● Partners and collaborates with site Project Management organization as required with higher level long term initiatives
● Provide qualification and validation assistance when necessary.
Knowledge, Skills, and Abilities:
Technical expertise in biotech unit operations and equipment, especially in the area of protein production and protein purification
Demonstrates proficiency in troubleshooting including process monitoring
Experience with project design, construction, start-up, commissioning and validation as well as supporting factory acceptance tests and site acceptance is a plus
Experience with automated equipment engineering and validation
Working knowledge and experience in cGMP environments (understanding of equipment, technology, and quality systems requirements) is required
Timely implementation of projects and quality improvement initiatives.
Excellent communication skills, organizational skills, writing and problem solving skills
Ability to work independently, manage multiple priorities, with the ability to prioritize and complete activities on time
May be required to work periodically out of normal business hours
Must be self-motivated, detail-oriented, collaborative, and able to work effectively in a fast-paced environment.
5S, OpEx, and Lean manufacturing experience a plus
BS in Chemical or Mechanical Engineering and 2+ years’ experience in a pharmaceutical / biotech / vaccine operations and validation principles, with thorough working knowledge of production unit operations.
Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.
EEO Minorities/ Disability/Veterans
Grifols is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and local laws that prohibit employment discrimination on the basis of race, color, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability or veteran's status or any other classification protected by applicable State/Federal laws. We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.
Req ID: 436627