Sr CSV and Automation Engineer - Thousand Oaks

VTI Life Sciences

$100K — $130K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's or Master's degree in engineering disciplines (Mechatronics, Mechanical, Electrical, or Computer Science) with relevant experience
  • 7+ years in industrial automation systems integration and/or control programming
  • 5+ years in the pharmaceutical/biotech industry with GMP experience
  • Strong knowledge of process, utility, and building control systems
  • Robust understanding of industry standards and regulations, including GMPs and CSV/CSA
  • Hands-on experience with PLC, HMI, and SCADA systems from multiple vendors
  • Ability to work independently and possess strong interpersonal skills.

Responsibilities

  • Lead start-up and commissioning of automated and critical process systems.
  • Identify and resolve automation issues, ensuring compliance with industry standards.
  • Produce and review design drawings and specification documents.
  • Generate, execute, and review qualification protocols for various operational phases.
  • Review and approve GMP Lifecycle Documents and manage change records effectively.
  • Ensure vendor information meets validation and control system requirements.

Benefits

  • Collaborative work environment with cross-functional teams.
  • Opportunity to work on cutting-edge automation technologies in the biotech sector.
  • Focus on professional growth and skills development in a specialized field.
Full Job Description
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.

Similar Jobs

More Jobs at VTI Life Sciences

More Pharmaceuticals & Biotech Jobs

Find similar Sr CSV and Automation Engineer - Thousand Oaks jobs: