Verista · 3 days ago
6187 - Sr. Validation Engineer / CQV Engineer - Change Management Focus
Indianapolis, IN
Full-time
Onsite
Mid, Senior Level
$60K/yr - $103K/yr
2+ years expVerista is a company that partners with leading brands in the life science industry to address critical business needs. They are seeking a detail-oriented Validation / CQV Engineer to support commissioning, qualification, and validation activities within regulated pharmaceutical environments, ensuring compliance with GMP and client requirements.
LegalHealthcareManufacturingPharmaceuticalLife ScienceComplianceHealth Care
Responsibilities
Support commissioning, qualification, and validation (CQV) activities for laboratory and manufacturing systems within GMP environments
Prepare, review, and route validation deliverables including protocols, reports, assessments, and supporting documentation
Ensure validation documentation is accurate, complete, traceable, and compliant with regulatory and client standards
Apply Good Documentation Practices (GDP) in authoring, reviewing, and maintaining validation records
Lead and support change control processes associated with validated systems, equipment, and procedures
Coordinate the end-to-end change lifecycle, ensuring impacts are properly assessed, documented, and approved
Act as a liaison between Quality, Engineering, Manufacturing, and client stakeholders to communicate changes effectively
Ensure changes are seamlessly integrated into validation strategies, procedures, and controlled documentation
Manage large volumes of validation documentation, including qualification packages, assessments, and remediation records
Utilize electronic document management systems (EDMS) and SharePoint to organize, track, and retrieve documentation
Support data integrity assessments and remediation efforts as required
Perform final document reviews prior to approval to ensure alignment with internal and client expectations
Collaborate with Quality Assurance, Engineering, Manufacturing, and client teams to gather technical input and execute validation strategies
Provide guidance and support to team members in locating documentation and navigating validation and change processes
Support project timelines by proactively tracking deliverables, approvals, and dependencies
Qualification
Required
Bachelor's degree in Engineering, Life Sciences, or a related technical discipline
2-4 years of experience supporting validation and CQV activities in pharmaceutical or regulated manufacturing environments
Demonstrated experience with change management and change control processes
Strong working knowledge of GDP, GMP, and regulatory expectations
Proficiency with EDMS platforms and Microsoft SharePoint
Excellent organizational, communication, and problem-solving skills
Ability to work effectively within cross-functional teams
Onsite work requirement in Indianapolis, IN
Benefits
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
Company
Verista
Verista offers transformative compliance, automation, packaging solutions for the life sciences, pharmaceutical and manufacturing.
501-1000 employees
H1B Sponsorship
Verista has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (7)
2024 (4)
2023 (13)
2022 (6)
2021 (1)
Funding
Current Stage
Late StageLeadership Team
Bill Murray
Chief Financial Officer
Dan White
Chief Operating Officer
Recent News
2023-12-22
2023-12-22
Company data provided by crunchbase