CSV Automation Specialist

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 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.

RESPONSIBILITIES:

• Authoring and Executing Software Test 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.

QUALIFICATIONS:

• Bachelor's degree or higher in Engineering, Life Sciences, or related discipline.
• 5+ 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.
• 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.

SALARY RANGE FOR THIS ROLE IS $80,000 - $105,000 ANNUALLY FOR A W2 EMPLOYEE

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