6516 - Laboratory Systems Specialist / Validation Engineer

United States·Indianapolismid

QA & TestingValidation Engineer

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Quick Summary

Key Responsibilities

Support day-to-day operation of laboratory and quality systems, instrument workstations, and associated technologies, including configuration, troubleshooting, and maintenance of laboratory computers,

Technical Tools

QA & TestingValidation Engineer

Description

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

Responsibilities

~2 min read

→Support day-to-day operation of laboratory and quality systems, instrument workstations, and associated technologies, including configuration, troubleshooting, and maintenance of laboratory computers, software, peripherals, and connectivity
→Coordinate software installations, upgrades, patches, and controlled configuration changes, partnering with laboratory users and support teams to resolve incidents and minimize operational disruption
→Maintain accurate technical documentation and contribute to hardware and software lifecycle planning
→Support deployment of new laboratory instruments, applications, and computerized systems, including workstation builds, system configuration, and domain or network migrations
→Coordinate vendor installation, upgrade, and implementation activities, contributing to implementation planning, test preparation, cutover, deployment, and hypercare support, and document technical dependencies, issues, and risks for escalation
→Support computer system validation and computer software assurance activities throughout the system lifecycle, contributing technical input to impact assessments, risk assessments, change controls, validation plans, and test scripts
→Execute or support qualification and testing activities, collecting complete, attributable technical evidence, and support deviation investigation, discrepancy resolution, periodic review, and audit or inspection readiness within applicable GxP, data integrity, and security requirements
→Coordinate with infrastructure and cybersecurity teams on endpoint management, access, network, server, backup, and recovery dependencies, supporting vulnerability remediation, patching, and approved security controls for regulated systems
→Assist with backup, restoration, disaster recovery, and business continuity planning and testing, and escalate infrastructure or cybersecurity risks affecting system availability, compliance, or validated state
→Support assigned technical activities across projects, tracking actions and deliverables and providing status updates, while participating in cross-functional working sessions and identifying process improvement opportunities

Requirements

~2 min read

Bachelor's Degree in Information Technology, Engineering, Life Sciences, or a related field
3+ years of experience supporting laboratory, manufacturing, quality, or other regulated computerized systems
Experience working in a GxP-regulated pharmaceutical, biotechnology, medical device, or comparable environment
Hands-on experience with LIMS, Veeva, chromatography data systems, instrument software, or other laboratory informatics platforms
Working knowledge of computer system validation, qualification, change control, and controlled documentation practices
Strong technical troubleshooting, root-cause analysis, and written communication skills, with the ability to work independently and manage competing priorities
Knowledge of GAMP 5, 21 CFR Part 11, data integrity principles, and risk-based validation or CSA methods
Experience with Windows administration, Active Directory, endpoint management, server dependencies, networking, and backup or recovery solutions (Preferred)
Experience supporting system migrations, hardware refreshes, vendor-led implementations, or cybersecurity remediation in regulated environments (Preferred)
Experience authoring or reviewing validation and technical lifecycle documentation (Preferred)

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

$73,920—$104,439 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