Yoh, A Day & Zimmermann Company Looking for Validation Engineer, Computer Systems at Raritan, NJ Full Time

Job Description

Responsibilities

• Participate in the development, implementation, execution and adherence to validation procedures and methods related to computer systems validation (CSV)
• Preparation, review and issuing of CSV documents as they related to computer systems:
• Proficient with eDocs, Word, Excel, MS Office, and SAP
• The CSV Engineer participates in the different developmental stages of the Computer System Validation Lifecycle, including Validation Plans, document development, Summary Reports, User Requirement Configuration Specifications, and other validation activities
• Responsible for Drafting and revising test methods, validation procedures, and protocols following industry practices, company standards, quality management systems, validation requirements, and regulatory agencies
• Author, execute, perform, summarize CSV documents: Validation Plans, User and Functional Requirements, Design Specifications, Risk Management Plans, Installation/Operational/Performance Qualification Protocols, Traceability Matrices, Final Reports, Deviation Handling
• Prepare review and approve CSV and compliance documentation according to cGxP guidance for audits, process performance, procurement, and compliance evaluations
• Develop, execute, and review qualification protocols, SOPs, validation plans, summary reports, change controls, traceability requirements, user requirements, functional and configuration specifications, gap, risk, and Impact assessments
• Plan, Write, review, and Execute CSV protocols, deviations, corrective actions, Summary Reports, Trace Matrices, and documentation of results
• Ensure, apply, and address compliance to system validation principles and regulations, such as 21 CFR Part 11, 820, and cGMP to all CSV activities and tasks
• Identify computerized systems validation needs through assessments and integration with IT Project Management Framework.
• Support change control activities, deviations and SOP’s for computer systems
• Ensure that the Validation / Qualification and quality systems are working in accordance with any changing and current regulations.
• Assist with technical functions such as Information Systems, Manufacturing, QA, Engineering, and validation activities of cross-functional teams
• Participate in the development of Validation methodologies in accordance with applicable Quality/Regulatory requirements and industry best practices
• Work closely with IT, Business and Quality to develop, coordinate and execute Validation documents and strategies
• Author/revise SOPs related to validation/qualification, operations, IT, as they relate to CSV
• Represent Validation in cross-functional team meetings/projects as required
• Effectively communicate with Leadership and all departments regarding Validation activities
• Participate in conducting root cause analysis, deviation resolution (CAPA), and effectiveness checks for CSV
• Organize and maintain validation documentation
• Apply Good Manufacturing Principles in all areas of responsibility
• Recommend acceptance of the computer system, as determined from the CSV tasks performed on the system.

Qualifications

• Bachelor’s Degree in Engineering, Science, or related field
• Must have a minimum of 5 years of experience in a life sciences industry, with focus on GxP, quality, and risk
• Minimum 3 years of automation experience
• Able to work independently and in interdisciplinary teams in a fast-paced environment
• In-depth knowledge of industry regulations (GMP, 21 CFR Parts 11, 210, 211, and 820 requirements, Data Integrity, ICH Q7A requirements, and GAMP)
• Excellent written and verbal communication skills
• Ability to communicate cross-functionally
• Proficient with eDocs, Word, Excel, MS Office, and SAP
• Ability to write and executed test scripts as related to CSV and GxP compliance.
• Hands on experience Identifing computerized systems validation needs through assessments and integration with IT Project Management Framework.
• Hands-on experience reviewing and initiating process improvements, change controls, test scripts, and system assessments, ensuring efficient regulatory and technical compliance of the CSV life cycle

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.