- Full Time
- Summit, NJ
Verista, Inc.
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
Job Overview: We are seeking an experienced CSV Engineer to support the implementation and validation of ELLA and Synergy Neo2 laboratory instruments. The ideal candidate should have hands-on experience supporting GxP laboratory instrument implementations and be comfortable managing validation activities for both technologies in parallel.
Validation Engineer Responsibilities:
- Support CSV activities for ELLA and Synergy Neo2 instrument implementation
- Develop, review, and/or execute validation deliverables including validation plans, risk assessments, test protocols, traceability matrices, summary reports, and related documentation
- Partner with laboratory, Quality, IT, and project stakeholders to ensure validation activities are completed on schedule
- Support GxP compliance, data integrity, and 21 CFR Part 11 considerations as applicable
- Manage validation workstreams for both instruments simultaneously
- Identify and escalate risks, gaps, delays, or documentation issues
- Support deviation resolution and documentation updates during protocol execution
Job Requirements:
- Strong CSV experience in a GxP laboratory or regulated life sciences environment
- Prior experience with laboratory instrument implementation and validation
- Experience with ELLA and Synergy Neo2 strongly preferred
- Ability to manage multiple validation activities or technologies concurrently
- Familiarity with IQ/OQ/PQ, CSV lifecycle documentation, risk-based validation, data integrity, and Part 11 expectations
- Strong communication skills and ability to work effectively with cross-functional teams
- Experience supporting ECQ or lab equipment qualification
- Experience in biotech, pharma, plasma, or manufacturing laboratory environments
- Prior experience working in client-facing hybrid/onsite roles
This role can be a local/hybrid setup. At minimum, a 50% on-site presence is required.
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.
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
Verista collects and processes personal data in accordance with applicable data protection laws. If you are a California Job Applicant, see the privacy notice for further details.
For more information about our company, please visit us at Verista.com
To apply for this job please visit job-boards.greenhouse.io.
Terms used in this posting
- hybrid
- A work arrangement combining both in-office and remote/at-home work, typically on a set schedule.
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Working in Summit, Union County
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New Jersey is a state located in both the Mid-Atlantic and Northeastern regions of the United States. Located at the geographic hub of the heavily urbanized Northeast megalopolis, it is bordered to the northwest, north, and northeast by New York State; on its east, southeast, and south by the Atlantic Ocean; on its west by the Delaware River and Pennsylvania; and on its southwest by Delaware Bay a
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- Elevation 122m (400 ft)
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