Industrial Automation and CSV Engineer - San Diego

VTI Life Sciences•Greater San Diego Area, CA

9d•Onsite

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 looking for a Computer System Validation (CSV) Specialist with Industrial Automation Knowledge to be responsible for ensuring that computerized systems used in regulated environments are validated in compliance with industry standards, regulatory requirements (such as FDA 21 CFR Part 11 and 820, Data Integrity, ISO 13485 and GAMP 5.), and company policies. The role includes the development and execution of validation protocols, risk assessments, and documentation to support the lifecycle of cGxP systems.The successful candidates will provide hands-on validation and testing support for PLC and SCADA controlled manufacturing systems. This role requires strong knowledge of industrial controls, automation architecture, equipment functionality, computerized system validation, data integrity, and regulated manufacturing practices.

Requirements

Bachelor's degree or higher in Engineering, Life Sciences, or related discipline.
7+ years of relevant FDA-regulated industry experience.
Expertise in regulatory requirements and guidance, including 21 CFR Part 11 and 820, Data Integrity, ISO 13485 and GAMP 5.
Familiarity with Python and Test Scripts.
3+ years of proven experience with SQL, Software Validation and Computerized Systems Validation.
Must have experience working in an FDA-regulated environment.
Experience with Automation Equipment such as HMI's, Robotized Manufacturing Systems and Vision Sensors.
Experience in manufacturing and testing of Medical Devices.
Advanced knowledge of PLC programming concepts and industrial automation architecture.
Hands-on experience with the Rockwell Automation suite and FactoryTalk View.
Experience testing equipment alarms, error codes, interlocks, system messages, and abnormal operating conditions.
Experience with databases, electronic records, part-traceability systems, and data-integrity principles.
Proficiency in Microsoft Office including Word, Excel, PowerPoint, MS Project, Visio, etc.
Exceptional technical writing, review and analytical skills.
Knowledge of good documentation practices and cGMP.

Responsibilities

Authoring and Executing Software Testing, FAT, SAT, IQ, OQ, and Test Method Validation protocols.
Draft, route, and execute Commissioning and Qualification Protocols (CQ, IQ, OQ, PQ) with Final Report.
Scheduling and execution of qualification activities
Qualification data collection and analysis against acceptance criteria.
Drafting and/or reviewing User Requirement Specifications/Software Requirement Specifications.
Software Design Specification drafting and review.
Documentation generation and updates (SOPs, PFMEA, Forms, etc.)
Meeting attendance and project coordination.
Provide all services in accordance with FDA cGxP guidelines and regulations.