Senior CSV Engineer / Senior Validation Engineer 2

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

Overview: The Senior CSV Engineer will be responsible for validating and verifying computerized systems that control or interface with laboratory equipment, ensuring data integrity and compliance. This includes writing, reviewing, and executing validation documents in alignment with regulatory expectations.

Responsibilities:

Validate GxP computerized systems/analytical instruments such as liquid handlers, Cellaca MX, and robotic arms

Lead development and execution of Data Integrity documentation, including: DI Specifications, User Access Test Scripts, Data Flow / Audit Trail Risk Assessments, Grouped and Individual DI Test Scripts

Participate in configuration reviews and verify implementation of system security, access roles, and audit logging

Coordinate closely with automation and validation engineering teams to ensure readiness of computerized systems for testing

Requirements:

Bachelor's Degree or equivalent required

5-10 years of industry experience

Strong understanding of GxP requirements and 21 CFR Part 11 compliance

Demonstrated experience drafting and executing DI testing across similar instruments as seen in complex lab environments

Familiarity with validation lifecycle documentation and electronic protocol management systems

Experience with highly automated systems that are integrated into systems such as Delta V or Syncade

This role requires the ability to be on-site full-time in Devens, MA.

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

$80,465—$122,603 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