1000 New Horizons Way Vacaville, CA 95688
Bayside Solutions is seeking a Validation Engineer to be part of our client’ s team in Solano County. 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.
- 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:
- Process, Validation or Mechanical engineer to support bio-tech manufacturing operations.
- Supports manufacturing operations through field troubleshooting, process monitoring, development of process improvements and implementation of capital and expense projects.
- Creation of validation test strategies, qualification test specifications, protocols and revalidation protocols.
- Generate User Requirement Specifications (URS) for new equipment introduction
- Provide execution support for washers, autoclaves, and other field equipment
- Perform field test execution (OQ, PQ)
- Perform data review based on test execution to assess acceptability
- Generate summary reports of test execution.
- Plan, perform and coordinate Mechanical Installation Qualification (MIQ), inclusive of test generation and execution (i.e. BDU Unit System).
- General Commissioning, Qualification and Validation (CQV)
- Prepare/ Author Qualification and Commissioning Protocols.
- Perform Testing, collects samples, analyzing test results, and prepares Commissioning and Qualification summary reports.
- Peer Reviews Validation Protocols, Commissioning Test and Design documents.
- Provide technical assessment and validation review/ approval for engineering, process and standard operating procedure changes.
- Prepare Risk Management Reports documenting system risks, applicable remediation/ risk reduction and critical controls.
- Maintain all required training to ensure job responsibilities can be performed on a daily basis.
- Vigilant to safety and maintains a safe environment for all during performance of job responsibilities (i.e. Validation Field Execution).
- Project closeout activities.
- Attend any project specific meetings as assigned.
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 and apply master 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
- Experience in Biotech industry a plus
- Experience in cGMP industry a plus