5727 - CSV Engineer / CSV Validation Specialist

Description

Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.

Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.

Company Culture Guidelines & Values:

• We empower and support our colleagues


• We commit to client success at every turn


• We have the courage to do the right thing


• We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.


• We constantly acquire new skills and learn from our experiences to enhance our collective expertise

CSV Analytical and Enterprise Validation Specialist will lead validation activities including, but not limited to, software updates, new system introduction, Administration of systems and applications, and decommissioning activities as appropriate. This person will work closely with other functional groups like Manufacturing, Operations Technology, Computer System Validation, Engineering, and Quality Assurance to support updates to help the site remain in compliance and contribute to quality, on-time delivery and right first-time performance.

CSV Validation Specialist Responsibilities:

• Provide Subject Matter Expert support to Quality Control, Manufacturing and other departments for the design, operation and troubleshooting of CSV, analytical and enterprise systems/applications


• Review and Approval of Installation Qualifications/Operational Qualifications and drafting Performance Qualifications as required


• Assist in generating User Requirements Specification Documentation, Electronic Records/Electronic Signatures, Data Integrity Risk Assessments and Audit Trail Risk Assessments


• Prepare Administration and Configuration specification document with support from vendor user manual


• Procurement of Analytical Equipment which includes ensuring system meets specifications, quotes, budgets and installations


• Performs user and application software administration on Enterprise systems. Works on troubleshooting assignments that are complex in nature where considerable judgment and initiative are required in making creative and effective recommendations to solve problems


• Create and or Revise SOPs for CSV, Analytical and enterprise systems and applications


• Participate on Risk Assessments


• Review/Approve Commissioning Qualification Validation Documents


• Perform other duties as assigned

Requirements:

• Education: Bachelor of Science - Science related discipline or relevant experience in the field


• Experience 5-10 Years


• Demonstrated delivery of CSV requirements 


• Demonstrated capability to deliver on the CSV responsibilities. 


• Ability to take independent leadership role on project(s)


• Proven ability to identify areas of business expansion and initiate technical discussion on Verista solutions for business expansion


• Onsite job requirements in Portsmouth, NH

Benefits

Why Choose Verista?

• High growth potential and fast-paced organization with a people-focused culture


• Competitive pay plus performance-based incentive programs


• Company-paid Life, Short-Term, and Long-Term Disability Insurance.


• Medical, Dental & Vision insurances


• FSA, DCARE, Commuter Benefits


• Supplemental Life, Hospital, Critical Illness and Legal Insurance


• Health Savings Account


• 401(k) Retirement Plan (Employer Matching benefit)


• Paid Time Off (Rollover Option) and Holidays


• As Needed Sick Time


• Tuition Reimbursement


• Team Social Activities (We have fun!)


• Employee Recognition


• Employee Referral Program


• Paid Parental Leave and Bereavement

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For more information about our company, please visit us at Verista.com