Sr CSV and Automation Engineer Thousand Oaks

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:
Bachelors degree in engineering (Mechatronics Mechanical Electrical or Computer Science preferred) with 7 years experience or a Masters 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 Sciencesstrives to maintain and inspire professional excellence by providing Commissioning Qualification Quality Engineering Automation and Validation Services to the Pharmaceutical Biotechnology Biologics and Medical Device 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 organizationVTIis 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