CSV Engineer/Analyst

Verista’s 600 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 Engineer/Analyst Responsibilities:

Documenting impact and risk assessments as part of a team.

Completing user interface testing, software verification, and complete alarm testing on automated systems.

Developing, reviewing, and executing testing documentation.

Making recommendations for design or process modification based on test results when executing test scripts.

Hands on experience with lab techniques and general lab analytical operations.

Understanding of baselined lab standards and system suitability verification.

Basic experience with IT system formats, configurations, and workflows.

General understanding of the business processes supporting one or more domains, such as: R&D, Clinical, Quality System Management, Supply Chain & Logistics, Commercialization.

Review and revision of all IT CSV project and system deliverables including but not limited to:

Plans

Requirements

Specifications

Test Protocols, Scripts and associated execution deliverables (such as test incident reports, etc.

Summary Reports

Change Controls

Review system operational and administration procedures to ensure they are adequate

Document any findings of non-compliance

Assist with strategy regarding remediation activities

Assist with review of remediation activities

Strong CSV QA/DI knowledge needed

Requirements

Experience in pharmaceutical cGxP setting with the ability to generate CSV deliverables with support of mentor.

Ability to work as part of a team.

Experience in GMP regulated environment.

Proven attention to detail and organization in project work.

Capable of working on assigned tasks without mentorship.

Demonstrated ability to generate CSV deliverables independently.

Ability to work independently and as part of a team, with the ability to transition between the two.

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

For more information about our company, please visit us at

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.

<$65,000 to $95,205>

*Verista is an equal opportunity employer.

Permanent