Process Engineer II
1000 New Horizons Way Vacaville, CA 95688
Bayside Solutions is seeking a Process Engineer II to be part of our client’ s team in Vacaville. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leading pharmaceutical corporations.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
Process Engineer II
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- Upstream Frontline Manufacturing (USFL) acts as the system owner for the Upstream cell culture production systems in the CCP2 facility. USFL supports the delivery of expense/capital projects and issue resolution during routine operations. This includes delivery of new or modified systems, troubleshooting and resolution of issues during the design and build of new / modified systems, assessments of deviations during operations, and implementation of corrections. Supports manufacturing operations through field troubleshooting, process monitoring, development of process improvements, and implementation of capital and expense projects.
- Providing input and comments into the capacity/manufacturing schedule analysis based on the existing process conditions and new process information.
- Interfacing on daily basis with automation/controls engineer counterpart in creating Functional Requirement Specifications for manufacturing operations
- Developing early level Functional Requirements Specification for the manufacturing area and interface with automation counterpart in developing the details of the functional requirement specification (FRS)
- Creation of commissioning and qualification test specifications and protocols related to manufacturing systems
- Provide/calculate process design and operating parameters associated with process changes
Summary of Qualifications:
- Bachelor' s degree in Chemical/Bio-Chemical/Mechanical Engineering
- Minimum 3-5 years of experience in manufacturing and equipment design
- Ability to understand specifications related to materials of construction, equipment/piping requirements and sanitary design including ASME BPE requirements.
- Demonstrated knowledge of automation as well as MOC, BPE and CXP/SXP, Utilities unit operations. General knowledge of automated process requirements and bio-tech related unit operations including utilities.
- Strong proficiency with MS Office and Google Suite products, especially Excel/Sheets. Familiarity with SAP, Tableau, SQL or other data analysis, reporting and visualization tools a plus.
- Familiarity with reliability engineering principles and techniques preferred. Project management, maintenance management, or lean six sigma experience a plus.
- Strong verbal communication skills and problem solving skills
- Ability to work independently
- Sound knowledge of current Good Manufacturing Practices (cGMPs) as they apply to biopharmaceutical manufacturing facilities or equivalent regulation
- Must have excellent interpersonal, communication, and teamwork skills
- Strong technical leadership, able to work independently or as part of a multidisciplinary team
- Ability to independently evaluate situations and propose potential solutions
- Expert knowledge with operations and engineering of pharmaceutical manufacturing facilities
- Possesses strong verbal and written communication skills and the ability to influence at all levels
- Capable at building trustful and effective relationships
- Able to think strategically and translate strategies into actionable plans
- Takes responsibility, drives results, and achieves expected outcomes
- Flexibility in problem solving and work hours to meet business objectives
- Experience in Biotech industry a plus
- Experience in cGMP industry a plus
- Must be able work weekends, off-shifts, and overtime as required.
- No make-up or jewelry can be worn when working in the clean room environment.