Posted 29 July, 2026
CSV Engineer LVL IV
TalentBurst, Inc.
Portsmouth, NH, US
Full Time
Job Description
Job Description
Job Title: CSV Engineer LVL IV
Job Location: Portsmouth, NH, United States
Duration: 9+ months
Job Description Summary:
The CSV Specialist Level 4 provides team leadership and training to assess new and changing computer systems to ensure compliance with company policies, procedures and industry guidance. The CSV Specialist Level 4 will risk assess systems, review change requests and test scripts, draft protocols and initiate and review GMP documentation revisions. Specialist will be involved as the QA CSV representative during small and large-scale projects.
Job Description:
Perform all aspects of QMS process' – Change Control, Deviations, CAPAs
Execute all responsibilities as CSV project lead for complex projects
Oversee all CSV lifecycle activities
Schedule qualification activities and personnel to meet business, manufacturing, engineering and quality objectives
Mentor junior specialists
Revise and maintain CSV SOPs
Assess departments standing in the business and regulatory aspects
Function as CSV SME in Inspections and Audits
Perform other duties as assigned.
Education:
Bachelor's Degree in Computer Science / Software Engineering
Computer Systems Validation
Computer Systems Validation - Advanced - 5-10 years
Agility*
Learns from experience, errors and setbacks
Helps others learn from experience to develop themselves
Challenges the status quo and looks for opportunities to make improvements in his/her area of the business and beyond
Embraces new initiatives and drives successful implementation in his/her area
Adapts thinking and behavior to support change
Takes personal responsibility for promoting change in his/her area
Understands how to effectively engage others in the change processes
Business Acumen*
Understands and explains the corporate strategy to his/her peers and/or team
Provides feedback to his/her managers on the content of the strategy and its implementation
Sets and delivers on individual and team objectives that support the company strategy
Uses knowledge of his/her business area and related areas to make correct and timely decisions
Uses knowledge of his/her own business area and related areas to identify and develop operational/financial improvements
Collaboration*
Works in partnership as an active member of his/her team and crossfunctional working groups * Mandatory field
Generously shares information and knowledge with others across teams and functions
Actively seeks out and shares different perspectives from a broad network and implements alternative approaches
Champions and role models the values of diversity and inclusion through everyday interactions in groups or 1:1s
Customer Focus*
Proactively seeks to understand internal/external customer and market needs
Develops insights that can be used to enhance customer satisfaction or other metrics
Identifies when company and customer interests may not align and seeks effective solutions to resolve or escalate
Manages internal and external customer relations professionally and effectively
Uses systematic approaches to ensure customer key metrics are tracked and analyzed for continuous improvement
Driving Results*
Establishes and consistently delivers on KPIs and challenging goals for him/herself (and team)
Proactively shares credit for successes
Helps peers (and team) overcome performance obstacles and challenges
Secures buy-in from key stakeholders
Ensures delivery excellence for own goals and those of his/her team
Regularly solicits, assesses and addresses feedback
Develops budgets and resource plans
Appropriately prioritizes multiple demands and leads defined work to successful conclusion on time
Leadership*
Supports others in taking responsibility for a safe and sustainable environment
Takes personal accountability for outcomes resulting from choices and behaviors of self and team
Seeks and provides feedback to their team to support professional development
Takes personal accountability for defining and implementing his/her own development and supports others to do same
Creates a positive work environment for his/her team and demonstrates high integrity
Ensures clear and direct 2-way communication within his/her team and other organisations
#TB_OTH
#ZRHC
#Linkd
Company DescriptionJob Location: Portsmouth, NH, United States
Duration: 9+ months
Job Description Summary:
The CSV Specialist Level 4 provides team leadership and training to assess new and changing computer systems to ensure compliance with company policies, procedures and industry guidance. The CSV Specialist Level 4 will risk assess systems, review change requests and test scripts, draft protocols and initiate and review GMP documentation revisions. Specialist will be involved as the QA CSV representative during small and large-scale projects.
Job Description:
Perform all aspects of QMS process' – Change Control, Deviations, CAPAs
Execute all responsibilities as CSV project lead for complex projects
Oversee all CSV lifecycle activities
Schedule qualification activities and personnel to meet business, manufacturing, engineering and quality objectives
Mentor junior specialists
Revise and maintain CSV SOPs
Assess departments standing in the business and regulatory aspects
Function as CSV SME in Inspections and Audits
Perform other duties as assigned.
Education:
Bachelor's Degree in Computer Science / Software Engineering
Computer Systems Validation
Computer Systems Validation - Advanced - 5-10 years
Agility*
Learns from experience, errors and setbacks
Helps others learn from experience to develop themselves
Challenges the status quo and looks for opportunities to make improvements in his/her area of the business and beyond
Embraces new initiatives and drives successful implementation in his/her area
Adapts thinking and behavior to support change
Takes personal responsibility for promoting change in his/her area
Understands how to effectively engage others in the change processes
Business Acumen*
Understands and explains the corporate strategy to his/her peers and/or team
Provides feedback to his/her managers on the content of the strategy and its implementation
Sets and delivers on individual and team objectives that support the company strategy
Uses knowledge of his/her business area and related areas to make correct and timely decisions
Uses knowledge of his/her own business area and related areas to identify and develop operational/financial improvements
Collaboration*
Works in partnership as an active member of his/her team and crossfunctional working groups * Mandatory field
Generously shares information and knowledge with others across teams and functions
Actively seeks out and shares different perspectives from a broad network and implements alternative approaches
Champions and role models the values of diversity and inclusion through everyday interactions in groups or 1:1s
Customer Focus*
Proactively seeks to understand internal/external customer and market needs
Develops insights that can be used to enhance customer satisfaction or other metrics
Identifies when company and customer interests may not align and seeks effective solutions to resolve or escalate
Manages internal and external customer relations professionally and effectively
Uses systematic approaches to ensure customer key metrics are tracked and analyzed for continuous improvement
Driving Results*
Establishes and consistently delivers on KPIs and challenging goals for him/herself (and team)
Proactively shares credit for successes
Helps peers (and team) overcome performance obstacles and challenges
Secures buy-in from key stakeholders
Ensures delivery excellence for own goals and those of his/her team
Regularly solicits, assesses and addresses feedback
Develops budgets and resource plans
Appropriately prioritizes multiple demands and leads defined work to successful conclusion on time
Leadership*
Supports others in taking responsibility for a safe and sustainable environment
Takes personal accountability for outcomes resulting from choices and behaviors of self and team
Seeks and provides feedback to their team to support professional development
Takes personal accountability for defining and implementing his/her own development and supports others to do same
Creates a positive work environment for his/her team and demonstrates high integrity
Ensures clear and direct 2-way communication within his/her team and other organisations
#TB_OTH
#ZRHC
#Linkd
Why TalentBurst?
At TalentBurst, we deliver more than talent, we deliver outcomes. We partner with you to move quickly and connect you to opportunities aligned with your skills and long term growth.
Backed by precision, transparency, and results, we connect top talent with leading organizations through trusted partnerships.
We offer competitive compensation and comprehensive benefits, including medical, dental, vision, and retirement options.
TalentBurst is an equal opportunity employer committed to an inclusive and diverse workforce.
Founded in 2002 by three former Monster.com executives; TalentBurst is an award-winning full-service Staffing Firm working directly with Fortune 500 companies in the US and Canada. We specialize in Contract and Contract to Permanent roles across many industries and have direct/contractual relationships with all our clients. Please visit our website www.talentburst.com or come meet us at our offices in Natick, MA, Miami, FL, Christiansburg, VA, Vineland, NJ, Houston, TX & downtown San Francisco, CA
