onsite: Portsmouth, New Hampshire

Job 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.
• 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.
• Advanced - 5-10 years

Competencies & Behaviors

• 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
• 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
• Works in partnership as an active member of his/her team and cross functional working groups
• 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
• 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
• 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
• 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 organizations
• Adherence to cGMPs is required at all times during the manufacture of drug products. 
• All personnel own the quality of what they deliver and are responsible for notifying responsible management in a timely manner of serious GMP deficiencies, process deviations, product defects and related actions
• Must know and follow job safety procedures, attend required health and safety training, proactively promote safety at work, and promptly report actual and potential accidents and injuries. 
• Must comply with safety policies of the company and site.
• 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

Education

• Bachelor's – Computer Science/ Software engineering
• Language – Business fluent – English

The hiring rate for this position is $80 to $87.54/per hour. The base pay actually offered will take into account internal equity, and may also vary depending on candidate's geographic region, job-related knowledge, skills, and experience amongst other factors.

Harvest Technical Services is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, Sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or any other federal, state, or local protected class.