The final salary or hourly wage, as applicable, paid to each candidate/applicant for this position is ultimately dependent on a variety of factors, including, but not limited to, the candidate’s/applicant’s qualifications, skills, and level of experience as well as the geographical location of the position.

Applicants must be legally authorized to work in the United States. Sponsorship not available.

Our client is seeking a Validation Specialist in New Jersey.

Role Description

6+ years experience Apply FDA, MHRA, and other applicable global health authority regulations to the development of computer systems supporting regulated business processes Follow SOPs and industry best practices Possess Expertise on Good Documentation and Good Testing Practices, in order to train those within the business that are less familiar. Facilitate the Computer system Validation Risk Assessment to identify governing regulations and validation deliverables during the development of the computer system Review validation deliverables for projects which are contracted to third party suppliers Maintain close communication with stakeholders and team members to keep apprised of computerized system needs, impacts on computer validation, project validation status, and other relevant issues Assist in planning, implementing, and documenting user acceptance testing

Review computerized systems validation documents such as: Requirements Specification

Design Specification
CSV Risk Assessment
Test Plans
Test Summary Reports
Data Migration Plan
Pre/Post Executed Test Scripts
Traceability Matrix

Release to Production Statements Direct and review testing Provide guidance on quality issues that affect the integrity of the data or the system Obtain and respond to QA review Participate in establishing standard quality and validation practices Independently assess compliance practices and recommend corrective actions Approve validated computer system related change requests Monitor regulatory and inspection trends and advise the business on suitable action Ability to create documents to an existing document standard. Able to develop all documentation required for a 21 CFR Part 11 validated project, including Validation Plans and Summaries. Advanced knowledge of complete MS Office suite and Visio. Firm understanding of technology platforms as needed for project. Experience with electronic document management systems (e.g. documentum, Qumas, SharePoint etc.); application development and lifecycle management (e.g. HP ALM, JIRA, etc.); and IT service management systems (e.g. ServiceNow, SAP Solution Manager, etc) Excellent oral and written communication skills in English. Strong expertise and ability to interview and accurately interpret communication requirements of team members. Once trained, have the ability to work independently on CSV projects with minimal oversight.

• Review computerized systems validation documents such as:
• Requirements Specification
• Design Specification
• CSV Risk Assessment
• Test Plans
• Test Summary Reports
• Data Migration Plan
• Pre/Post Executed Test Scripts
• Traceability Matrix
• Release to Production Statements

Direct and review testing
Provide guidance on quality issues that affect the integrity of the data or the system
Obtain and respond to QA review
Participate in establishing standard quality and validation practices
Independently assess compliance practices and recommend corrective actions
Approve validated computer system related change requests
Monitor regulatory and inspection trends and advise the business on suitable action
Ability to create documents to an existing document standard.
Able to develop all documentation required for a 21 CFR Part 11 validated project, including Validation Plans and Summaries.

Advanced knowledge of complete MS Office suite and Visio. Firm understanding of technology platforms as needed for project.
Experience with electronic document management systems (e.g. documentum, Qumas, SharePoint etc.); application development and lifecycle management (e.g. HP ALM, JIRA, etc.); and IT service management systems (e.g. ServiceNow, SAP Solution Manager, etc)
Excellent oral and written communication skills in English. Strong expertise and ability to interview and accurately interpret communication requirements of team members.
Once trained, have the ability to work independently on CSV projects with minimal oversight.
Ability to perform in a highly matrixed organization structure

Benefits/Other Compensation

This position is a contract/temporary role where Hays offers you the opportunity to enroll in full medical benefits, dental benefits, vision benefits, 401K and Life Insurance ($20,000 benefit).

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there’s a position you really want, you’re fully prepared to get it.

Nervous about an upcoming interview? Unsure how to write a new resume?

Visit the Hays Career Advice section to learn top tips to help you stand out from the crowd when job hunting.

Hays is committed to building a thriving culture of diversity that embraces people with different backgrounds, perspectives, and experiences. We believe that the more inclusive we are, the better we serve our candidates, clients, and employees. We are an equal employment opportunity employer, and we comply with all applicable laws prohibiting discrimination based on race, color, creed, sex (including pregnancy, sexual orientation, or gender identity), age, national origin or ancestry, physical or mental disability, veteran status, marital status, genetic information, HIV-positive status, as well as any other characteristic protected by federal, state, or local law. One of Hays’ guiding principles is ‘do the right thing’.
We also believe that actions speak louder than words.
In that regard, we train our staff on ensuring inclusivity throughout the entire recruitment process and counsel our clients on these principles. If you have any questions about Hays or any of our processes, please contact us.

In accordance with applicable federal, state, and local law protecting qualified individuals with known disabilities, Hays will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570.

Drug testing may be required; please contact a recruiter for more information.

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