Senior CSV Engineer/Analyst - Senior Validation Engineer 2 - 4908

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

Senior CSV Engineer Responsibilities:

A skilled laboratory validation resource with experience validating LIMS and Chromatography Data Systems (CDS), performing execution of instrument/software validation with no guidance, and interfacing with instrument vendors to determine scope of testing.

• Independently understanding client’s quality standards, cGMP’s, and regulatory standards to support team in compliance of validation effort
• Independent verification of testing against specifications
• Managing and working collaboratively with clients’ quality representative to complete deviation investigation and resolution for problems and issues encountered during execution activities. Includes ability to complete root cause analysis

Requirements

• Direct experience and understanding of complex automated lab systems such as HPLC, GC, TOC, UV/Vis, Plate Readers and automated titrators
• Direct experience authoring and executing validation documentation for LIMS and CDS
• Direct experience utilizing Veeva for validation activities
• Familiarity with bench top analytical equipment and have worked with chromatography and LIMS system sample workflows
• Experience with lab system configuration and operation
• Understanding of system integrations, including but not limited to understanding of how integrations are designed / constructed, data flow from source systems to target systems, typical testing approach for system integrations
• 6-10 years of relevant Laboratory CSV experience
• Must be available to work onsite at client site in Norwood, MA in a hybrid role
• Obvious business maturity and interpersonal skills to be able to effectively communicate and collaborate
• Experience and capability of effectively communicating requirements (written and orally) with rationale to different levels of the client’s organization
• 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
• Capacity to make independent sound decisions and independently manage priorities
• Advanced Microsoft WORD, EXCEL, and PowerPoint capabilities

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 Verista.com

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.

$80,465-125,498

*Verista is an equal opportunity employer.