CSV Specialist Level 3/Validation Engineer

Position Title: CSV Specialist Level 3/Validation Engineer Work Location: Portsmouth NH 03801 Assignment Duration: 6 Months Work Arrangement: Onsite (5 days per week) Position Summary: 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 Key Responsibilities: • 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 Qualification & Experience: • Bachelor's Degree in Computer Science / Software Engineering • English required • Computer Systems Validation – Advanced - 5-10 years • 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 • 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 Working Conditions & Physical Demands (If Applicable): Work Schedule: Regular Office Hours Travel: <10% = low Safety: 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. Quality Responsibility: Adherence to cGMPs is required at all times during the manufacture of APIs. All personnel own the quality of what they deliver and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions. Environmental Demands: The normal working environment is: Office Setting Mental Demands: • Ability to handle multiple tasks while working within scheduled timelines • Ability to change priorities as schedules change Additional Information (If Applicable): Key Stakeholders: Controls Automation, MES eBR, Engineering Supervision Received: General Supervision People: 0 Budget: N/A Quality: 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. Safety: 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.

Salary : $777 - $7,931