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Skills: Computer System Validation, Equipment Qualification, LabVantage LIMS, GxP, 21 CFR Part 11
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$79k–$109k/yr
Full-time
bachelor degree
Life Insurance, Short-Term Disability Insurance, Long-Term Disability Insurance, Medical Insurance, Dental Insurance, Vision Insurance
Posted 16d ago
~40 hrs/week
Responsibilities
Lead and execute computer system validation and equipment qualification activities for laboratory systems integrated with LabVantage LIMS. Ensure all activities comply with GxP, data integrity, and 21 CFR Part 11 regulations while managing documentation and troubleshooting.
Requirements
Requires a bachelor's degree in a technical discipline and at least 5 years of experience in CSV or equipment qualification within a regulated life sciences environment. Strong hands-on experience with LabVantage LIMS and vendor-provided qualification protocols is essential.
Full 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
Senior Validation Engineer Responsibilities:
Lead and execute computer system validation and equipment qualification activities for laboratory equipment integrated with LabVantage LIMS in a GxP-regulated environment
Qualify and validate laboratory instruments and systems, with a primary focus on Climet environmental monitoring instruments and similar laboratory equipment that interface with LabVantage
Execute vendor-provided qualification documentation and protocols, including SAT, IQ, OQ, and related testing, ensuring activities are performed in accordance with approved procedures and protocols
Support the execution and documentation of qualification activities for laboratory instruments, primarily using existing approved protocols and documentation with minor updates to reflect equipment-specific differences
Leverage existing approved validation and qualification documentation to efficiently develop or update URS, risk assessments, IQ/OQ documentation, test scripts, traceability, and validation summary documentation for equipment that is substantially equivalent to existing qualified units
Evaluate existing equipment qualification and validation packages to identify required updates based on instrument configuration, LIMS integration, software, hardware, or other equipment-specific differences
Perform and document testing of LIMS interfaces and data flows associated with laboratory instruments, ensuring accurate, complete, and reliable transfer of data between equipment and LabVantage
Review vendor documentation and protocols for completeness and applicability and identify any gaps or deviations requiring resolution prior to or during execution
Execute validation and qualification activities in accordance with GxP, data integrity, 21 CFR Part 11, company validation procedures, and applicable CSV/CSA principles
Document test results, deviations, discrepancies, and exceptions and support resolution through appropriate investigation, change control, and CAPA processes
Collaborate with Laboratory, Quality, IT, Validation, equipment vendors, and system owners to coordinate qualification activities and resolve technical or documentation issues
Support validation documentation closeout, ensuring qualification packages are complete, accurate, traceable, and audit-ready
Provide technical support for the laboratory equipment and LabVantage environment following qualification, including troubleshooting and assessment of changes impacting the validated state
Job Requirements:
Bachelor’s degree in Engineering, Computer Science, Life Sciences, Information Systems, or related technical discipline
5+ years of CSV, equipment qualification, or validation experience in a regulated life sciences environment
2–3+ years of experience qualifying laboratory equipment integrated with a LIMS, with hands-on LabVantage LIMS experience strongly preferred
Demonstrated experience executing vendor-provided qualification protocols, including SAT and IQ/OQ, and accurately documenting test results, deviations, and exceptions
Experience developing, reviewing, and executing validation and qualification documentation, including URS, risk assessments, IQ/OQ, test scripts, traceability, deviations, and validation summary reports
Ability to leverage existing approved qualification and validation packages and efficiently adapt documentation for equivalent or similar laboratory equipment with minimal configuration differences
Strong understanding of GxP, CSV/CSA, data integrity, 21 CFR Part 11, change control, and validation lifecycle requirements, including testing of LIMS interfaces and data flows
Strong attention to detail, organization, troubleshooting, and communication skills, with the ability to manage a high-volume validation backlog and collaborate effectively with Laboratory, Quality, IT, Validation, and equipment vendors
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
$78,925—$108,980 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
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
Related keywords
CSVComputer System ValidationEquipment QualificationLabVantageLIMSGxP21 CFR Part 11Data IntegritySATIQOQURSRisk AssessmentTest ScriptsTraceabilityValidation Summary
Integrated Strategy, Solutions, and Execution for the Life Sciences
Industry
Pharmaceutical Manufacturing
Company size
501-1,000 employees
Headquarters
Fishers, Indiana
LinkedIn followers
38,038
Verista helps life sciences companies solve complex quality, compliance, validation, technology, and operational challenges with greater confidence, speed, and control.
Our teams bring together expertise in CQV, CSV and CSA, quality and data integrity, regulatory readiness, automation, digital transformation, IT security, and advanced technology solutions. By connecting these capabilities, we help clients reduce risk, accelerate execution, eliminate silos, and maintain compliance from strategy through implementation.
Verista supports pharmaceutical, biotechnology, medical device, and other regulated organizations as they launch facilities, modernize systems, prepare for inspections, and strengthen operations.
Our approach is practical, collaborative, and grounded in real-world life sciences experience, helping clients move critical initiatives forward when timing, compliance, and performance matter most.
What matters most can’t wait.
Offices: 9100 Fall View Dr, Fishers, Indiana 46037, US · 950 W Valley Rd, Suite 2400, Wayne, Pennsylvania 19087, US · 1 Technology Park Dr., Suite 1, Westford, Massachusetts 01886, US · 400 Concar Dr,, San Mateo, CA 94402, US
computer system validationCQVQMSautomation engineeringR&Dmachine vision21 CFR Part 11lab systems & informaticsEnterprise ITpackaging
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