Process Engineer I
1000 New Horizons Way Vacaville, CA 95688
Bayside Solutions is seeking a Process Engineer I 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 I
- 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:
- Downstream Frontline Manufacturing (DSFL) acts as the system owner for the Downstream purification systems in the CCP2 facility. DSFL 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.
- This position will be an entry-level position. The primary focus of this position is to develop content for functional specifications (Upstream Manufacturing). This work will provide a foundational understanding of the system, enabling further development and capabilities.
- Contribute to project scope definition, schedule and project estimate
- Review/update process description and parameters list
- Assist in development of User Requirements Specification (URS)
- Participate in design review meetings
- Develop equipment maintenance strategies
- Provide both long- and short-term analysis and reporting of equipment and process performance.
- Make recommendations to improve operations. This could include all areas of operational support; bio-process improvements to maintenance improvements
- Collaborate with maintenance, manufacturing and other groups to troubleshoot and solve operational problems and equipment failures
- Conduct field audits to identify gaps between P&IDs and as-built construction
- Update process flow diagrams
- Update existing P&IDs with new/reconfigured process information
- 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 1-3 years of experience in manufacturing and equipment design
- Experience in Biotech industry a plus
- Experience in cGMP industry a plus
- 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