Automation Engineer
About The Position
VTI Life Sciences (VTI) is seeking forward-thinking and ambitious engineers looking to accelerate their career in the pharmaceutical, biotechnology and medical device industries. We offer an opportunity to help support our teams of industry subject matter experts and thought leaders while consulting with some of the biggest companies in the Life Sciences industry. We are seeking a highly skilled Pharmaceutical Automation Engineer to support automation and qualification activities for critical systems in a regulated pharmaceutical environment with our San Francisco Bay Area pharmaceutical client. The ideal candidate will have hands-on experience with automation platforms and a deep understanding of compliance and quality standards. A fundamental understanding of ASTM3500 will be considered a significant advantage, as it underpins risk-based approaches to design, qualification, and commissioning in compliance with industry best practices. VTI Life Sciences strives to maintain and inspire professional excellence by providing Commissioning, Qualification, Quality Engineering, Automation and Validation Services to the Pharmaceutical, Biotechnology, Biologics and Medical Device industries. VTI offers professional development, training, competitive compensation, excellent benefits, a matching 401K, plus a stimulating and collaborative work environment. We are committed to providing exciting career opportunities in a work environment that values trust, respect, openness, teamwork, creative talent, enthusiasm and diligence. As one of the leading global Commissioning, Qualification and Validation Services organizations, VTI is always looking for innovative, talented and experienced validation professionals for our multinational and global offices. We offer some of the best salary and benefit packages in the industry for our full-time/permanent employees. www.validation.org
Requirements
- Bachelor’s degree in Engineering, Computer Science, or related field.
- Minimum [8] years of experience in pharmaceutical automation engineering.
- Proficiency with Allen-Bradley FactoryTalk and related automation platforms.
- Strong knowledge of GMP, Pharmaceutical Quality Systems, and regulatory compliance.
- Experience developing and executing qualification documentation and QRM deliverables.
- Excellent analytical, documentation, and communication skills.
Nice To Haves
- A fundamental understanding of ASTM3500 will be considered a significant advantage, as it underpins risk-based approaches to design, qualification, and commissioning in compliance with industry best practices.
Responsibilities
- Configure, troubleshoot, and commission automation systems including: SCADA Systems Process Control Systems (PCS) Environmental Monitoring Automation Systems (utilizing Allen Bradley FactoryTalk platform)
- Author and execute key project documentation: System Impact Assessments Functional Risk Assessments Qualification Project Plans Data Migration Plans (as applicable) Test Plans (as applicable) Requirements Traceability Matrix Design Qualification (DQ) development and execution
- Ensure compliance with the client’s Pharmaceutical Quality System and regulatory requirements.
- Develop and maintain Quality Risk Management (QRM) deliverables.
- Collaborate with cross-functional teams to ensure successful automation integration and qualification.
Benefits
- VTI offers professional development, training, competitive compensation, excellent benefits, a matching 401K, plus a stimulating and collaborative work environment.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
51-100 employees
