Grifols Shared Services North America, Inc Engineer II, MS&T in Emeryville, California
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 II 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:
● Ability to initiate and lead process equipment improvements, onboarding and purchase of new equipment and investigation studies. Coordinating vendor visits for onsite service, work with instrumentation group for other calibration events.
● Provides guidance to staff with production support activities including pre-production checks and equipment testing activities as required
● Ability to design and execute system/equipment based studies to screen, optimize, and scale production processes, analyzes and interprets results, participates in process improvement, development, scale up and qualification activities.
● Provide technical support for new products to site including process/equipment feasibility assessments, process and equipment requirements
● Evaluates new technology and supports implementation of new process equipment into GMP manufacturing.
● 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.
● Prepares equipment related operating procedures and/or relevant engineering documents (SOPs, protocols & reports for FATs, comparability, manufacturing process validation testing), 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.
● 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
● Provides support to ensure successful manufacturing process comparability and process validation runs by assessing risk, setting preventative measures in place, investigating, and troubleshooting equipment/process related issues
Knowledge, Skills, and Abilities:
Technical expertise in biotech unit operations and equipment, especially in the area of protein production and protein purification
Experience with project design, construction, start-up, commissioning and validation as well as leading and supporting factory acceptance tests and site acceptance 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
Experience supporting FDA and other Regulatory inspections a plus
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 Biochemical, Chemical or Mechanical Engineering and 5 years’ experience (Masters with 3+ years’) 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.
- May occasionally lift, carry, push, pull or otherwise manipulate objects up to 25 pounds in weight, and/or lift, carry, push, pull or otherwise manipulate objects up to 10 pounds in weight frequently or continuously. 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: 237631