What are the responsibilities and job description for the Sr CSV and Automation Engineer - Thousand Oaks position at VTI Life Sciences?
VTI Life Sciences (VTI) is seeking forward-thinking and ambitious industrial automation engineers looking to accelerate their careers 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 currently seeking an Industrial Automation Engineer to support mechatronics and automation-related Commissioning and Qualification projects at a VTI client in Thousand Oaks, CA. The role will require effective collaboration and support with functional areas such as Manufacturing, Quality, Process Engineering, Validation, and other applicable stakeholders.
Responsibilities:
• Lead the start-up and commissioning of automated equipment, systems, and critical process utility systems.
• Lead automation issue identification and resolution, including all compliance aspects such as Deviation investigation, Change Control, and Corrective and Preventive Action (CAPA)
• Produce and review design drawings and specification documents (URS, FS, DS, etc.)
• Generate, execute, and review Installation, Operational, and Performance Qualification protocols.
• Generate, review, and approve GMP Lifecycle Documents (e.g., risk documents, trace matrices, periodic reviews). Initiate, execute, and track progress on change records.
• Review and approve vendor information packages, including drawings and specifications, to ensure validation and control system requirements are met.
Qualifications:
• Bachelor’s degree in engineering (Mechatronics, Mechanical, Electrical, or Computer Science preferred) with 7 years’ experience, or a Master's degree in Engineering (Mechatronics, Mechanical, Electrical, or Computer Science preferred)with 5 years’ experience.
• Minimum of 7 years of applicable industrial automation systems integration and/or programming control experience.
• Minimum of 5 years in the pharmaceutical/biotech industry/GMP experience.
• Knowledge of process, utility, and building control systems.
• Strong understanding of GMPs, Computerized Systems Validation/Assurance (CSV/CSA) and Good Engineering Practice (GEP), including ISA S88/S95, GAMP, ASTM E2500, ISPE guidance, 21 CFR Part 11, Annex 11, Data Integrity.
• Commissioning, Start-Up, and Qualification experience related to control and computer systems.
• Experience in the implementation of PLC, HMI and SCADA automation systems such as Rockwell, Factory TalkView, Siemens, Honeywell, Delta V, etc.
• Ability to work most of the time independently with minimal direct supervision.
• Demonstrate excellent interpersonal skills.
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 401K, and a stimulating, 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 a leading global Commissioning, Qualification, and Validation Services organization, VTI is always seeking innovative, talented, and experienced validation professionals for our multinational offices. We offer some of the best compensation and benefits packages in the industry for our full-time/permanent employees, as well as competitive hourly pay for our contractors. www.validation.org