Validation Engineering

Validation Engineer 2
Location: Portsmouth, NH Job Duration: 6 months
The CSV Specialist Level 3 helps to lead team members to assess new and changing computer systems to ensure compliance with company policies, procedures and industry guidance. The CSV Specialist Level 3 will risk assess systems, review change requests and test scripts, draft protocols and initiate and review GMP documentation revisions. This position also provides guidance to junior team members. 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 simple projects
Oversee/perform all CSV qualification activities for DeltaV and Syncade systems
Perform Validation Maintenance of computerized systems
Review/Revise CSV SOPs
Perform review of Engineering documents (P&IDs, SOPs, Specifications, Submittals, etc.)
Assist with audits and inspections
Perform other duties as assigned
Competencies & Behaviors

Demonstrates an ability and desire to learn from experience
Treats errors as a learning opportunity
Is willing to take on new challenges
Takes steps to adapt thinking and behavior to support change
Supports a culture of process improvement and problem solving
Demonstrates an openness to trying new approaches
Seeks to understand the corporate strategy and how his/her business area contributes to the company's success
Understands the impact of his/her own actions on his/her business area
Expresses ideas that will improve his/her business area
Uses knowledge of his/her business area to make accurate and timely decisions
Works as an active member of his/her team
Generously shares information and knowledge with others on team
Demonstrates an openness to different perspectives by balancing listening and speaking
Treats all co-workers and customers professionally and with respect
Understands what internal and/or external customers need from him/her to deliver in his/her respective role
Demonstrates an openness to receiving customer feedback
Takes action to enhance customer satisfaction within the scope of his/her role
Consistently delivers goals while monitoring KPIs with supervisor
Demonstrates persistence and motivation to overcome obstacles and challenges
Ensures quality standards are maintained while delivering results
Plans, prioritizes and organizes work to deliver on time
Takes responsibility for his/her safety and that of others
Takes responsibility for personal choices and behaviors
Seeks feedback and reflects on his/her development needs in order to continuously improve
Contributes to a positive work environment
Acts as a reliable and dependable member of the team
Skills

Experience with 21 CFR Part 11 and ISPE GAMP guidelines as they relate to Computer Systems Validation
Strong written and oral communication skills
Strong organizational and time management skills