Collabera · 9 hours ago
Entry Level Quality Engineer – Computer System Validation and Digital Systems
Fort Lauderdale, FL
Contract
Onsite
Entry Level
$30/hr - $36/hr
3+ years expCollabera is seeking a Quality Engineer with strong expertise in Computer System Validation and digital manufacturing systems to support regulated operations. This role focuses on ensuring compliant validation strategies for manufacturing, utilities, and digital platforms while maintaining data integrity and inspection readiness.
ConsultingInformation ServicesInformation Technology
Hiring Manager
Gagandeep Singh
Responsibilities
Review and approve Computer System Validation lifecycle documentation including validation plans, user requirements, functional specifications, risk assessments, and qualification protocols
Ensure risk-based validation approaches aligned with GAMP guidelines, regulatory requirements, and data integrity principles
Assess system changes through change control and determine validation and compliance impact
Support periodic reviews and revalidation activities for existing computerized systems
Act as Quality reviewer and approver for manufacturing execution, electronic batch records, historians, analytics platforms, and laboratory systems
Review system configurations related to audit trails, access controls, electronic records, and electronic signatures
Evaluate and approve data flows, interfaces, and integrations between regulated systems
Support internal audits and regulatory inspections related to computerized systems
Collaborate with Engineering, Automation, Manufacturing Science and Technology, Information Technology, and Operations teams to enable compliant and efficient project execution
Provide Quality input during design, factory acceptance testing, site acceptance testing, commissioning, and qualification activities
Qualification
Required
Master's degree in Engineering, Computer Science, Life Sciences, or a related field
Minimum of three years of experience in pharmaceutical or regulated manufacturing environments
At least two years of experience working within a Quality organization
Three or more years of hands-on experience reviewing and approving Computer System Validation documentation
Direct experience supporting manufacturing or utilities systems
Strong knowledge of validation lifecycle practices, regulatory compliance, and data integrity requirements
Preferred
Experience supporting manufacturing execution systems, process historians, and advanced analytics platforms in regulated environments
Exposure to commissioning and qualification activities integrated with validation efforts
Prior participation in regulatory inspections related to computerized systems
Experience supporting digital transformation or advanced manufacturing initiatives
Benefits
Medical insurance
Dental insurance
Vision insurance
401(k) retirement plan
Life insurance
Long-term disability insurance
Short-term disability insurance
Paid parking or public transportation
Paid time off
Paid sick and safe time
Hours of paid vacation time
Weeks of paid parental leave
Paid holidays annually – as applicable
Company
Collabera
Collabera is an end-to-end information technology services and solutions provider helping clients align their business and IT strategies.
10001+ employees
H1B Sponsorship
Collabera 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 (141)
2024 (93)
2023 (120)
2022 (186)
2021 (180)
2020 (146)
Funding
Current Stage
Late StageTotal Funding
$30M2006-05-04Series Unknown· $30M
Leadership Team
Lalit Sharma
CFO
Michael H. Abraham
Chief Financial Officer
Recent News
2026-02-06
2024-04-09
2023-01-20
Company data provided by crunchbase