Computer Systems Validation Engineer I

Description

With limited supervision, the candidate will be responsible for oversight of all GxP-Regulated Computerized Systems at all applicable points of the computerized system lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation (CSV) and Lifecycle procedures with Data Integrity requirements. This individual will provide oversight of validation activities, lead the development and approval of validation documentation, risk assessments, work with project teams to determine which elements should be validated, and conduct impact assessments of proposed changes to computerized systems.

Job Responsibilities

• Carries out responsibilities in accordance with Aveva’s policies, procedures, and safety rules in accordance with local, state and federal laws.
• Interfaces with a cross-functional team within the organization on Computer System Validation requirements for new and existing systems.
• Develop, approve and execute validation deliverables for computerized systems and relevant infrastructure, including Validation Plans, Requirements Specification, Risk Assessments, Installation/Operational Qualifications, Traceability Matrices, and Validation Final Reports, ensuring documents meet regulatory and procedural requirements of 21 CFR Part-11, Annex-11 Data Integrity and GAMP5 among others
• Perform Periodic Reviews and ensure that the validated state of the computerized systems are maintained in accordance with Aveva DDS requirements, policies as well as regulatory agency requirements
• Must be able to create, review, and update SOPs, forms, templates, documentation, and files.
• Supports regulatory and client audits as CSV subject matter expert.
• Participate and interface with cross-functional project team members (Engineering, Manufacturing, Regulatory Affairs, Quality Operations, Quality Validation, Supply Chain, and other technical disciplines) representing the respective validation elements, as applicable, to determine validation strategy and system validation requirements based on concepts of life cycle user requirements, functional specifications, design specifications, commissioning, and validation. Emphasis is on ensuring accuracy and integrity on validation documentation meets regulatory guidelines.

Qualifications

Job Requirements

Education

• A Bachelor’s degree in Computer Science, Engineering or similar discipline with 5 Years of experience in Computer System Validation activities within pharmaceutical, biotechnology or other manufacturing life science industry regulated by FDA. or
• A Master’s degree in Computer Science, Engineering or similar discipline with 3 Years of experience in Computer System Validation activities within pharmaceutical, biotechnology or other manufacturing life science industry regulated by FDA.

• Knowledge, Skills and Abilities

• Knowledge of 21 CFR Part 11, Annex 11, Data Integrity, GAMP5 requirements and FDA industry regulations.
• Working knowledge of engineering principles.
• Working knowledge and expertise in computerized systems validation.
• Computer System Validation experience with DCS, SCADA and BMS systems such as JDE Edwards, LIMS, Empower, etc. is preferred.
• Analyzing and troubleshooting problems, identifying solutions and recommending and implementing methods, procedures, systems and/or techniques for resolution.
• Performing necessary projects, assignments to implement goals and objectives for effective, efficient and cost effective management of allocated resources.
• Functioning as an individual contributor, with minimal supervision.
• Communicating effectively, both orally and in writing.
• Establishing and maintaining cooperative working relationships with those contacted (internal and external) in the course of work.
• Handle multiple projects and tasks.

Experience

• 3-5 years experience or more performing as Computer System Validation Engineer in a cGMP regulated manufacturing environment or an equivalent combination of training and experience is required.

Salary : $90,000 - $105,000