CSV Engineer / CSV Validation Specialist

Job Description

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

For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.

*Verista is an equal opportunity employer.

National (US) Range

$56,980—$81,735 USD

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

Full-time