Validation Engineer IV
1000 New Horizons Way, VAC10 Vacaville, CA 95688
Bayside Solutions is seeking a Validation Engineer IV 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.
Validation Engineer IV
- 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:
- Provide Automation Validation Engineering Support to Vacaville Manufacturing Operations for CCP1 Automation, focused on the Control Layer Replacement project.
- Completion of all applicable training requirements required to support project activities
- Development and approval of Qualification Project Plan and Summary Report for the project
- Support in development of design and risk assessment documents
- Development, approval and execution of qualification deliverables for the completion of Commissioning & Qualification (C&Q) activities in accordance with procedures and approved Qualification strategy
- Manage Automation Engineering Trace Matrix (ETM) through completion and Quality approval
- Generation and approval of new Automation test typicals, as needed
- Train additional team members to execute protocols, if needed
- Update test typical testing instructions for clarification
- Develop training guide to support execution of AIQ/AOQ.
Summary of Qualifications:
- Bachelor’ s degree (Life Science, Engineering, Biology, Biochemistry) or equivalent validation/GMP job experience.
- Twelve or more years’ experience in C&Q of Automation systems in GMP manufacturing environments
- Solid understanding of regulatory compliance, good manufacturing practices and validation principles, and the ability to apply that knowledge.
- Thorough understanding of cGMP’ s particularly as they relate to the operation, validation and maintenance of computer-controlled systems.
- Experience with distributed control system, software development methodologies and automated system life cycle support in a regulated industry.
- Experience with DeviceNet and Allen-Bradley ControlLogix is a plus.
- Effective communication and interpersonal skills with technical, operations, manufacturing, quality and engineering personnel as well as project personnel leadership.