Katalyst CRO · 1 day ago
Validation Engineer
Liberty, SC
Contract
Hybrid
Mid Level
3+ years expKatalyst CRO is a company focused on providing validation services in the Life Sciences sector. The Validation Engineer will provide validation experience and guidance during various project phases, ensuring compliance with validation policies and overseeing execution of validation qualifications.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Provide validation experience and guidance during equipment design, software design, build, debug, and qualification phases of a project
Write overall project quality (validation scope) plans. Organize, guide, and write requirement specifications as necessary
Review qualification/requalification packages for completeness and accuracy, sound rationale, compliance with validation policies. Interface with internal and client validation and engineering teams to secure document approvals
Oversee and execute validation qualifications at our facility and at the customer's site
Organize, guide, and write qualification plans and protocols as necessary
Work through validation documentation in a timely manner to meet project schedules
Create validation summary reports. Provide input to address validation deviations and/or change requests and identify qualification requirements to ensure compliance to system's current validated state and all cGxP's
Drive a quality approach into the organization, change control, and documentation for the equipment design, software, and documentation. Support all aspects of the Validation Life Cycle, from design through operation and improvement. Develop pertinent document templates tailored to customer SOP's
Qualification
Required
3+ years performing validation activities
Proficient in Microsoft Office
Excellent presentation skills and ability to mentor without direct authority
Ability to work in a team environment
Self-starter, able to work with minimal guidance
Bachelor of Science degree (B.S.) in Systems Engineering, Life Sciences, Electrical/Controls Engineering, or Quality Assurance, related experience or the equivalent of
Preferred
Experience in custom engineered solutions, Medical Devices, or Life Sciences
Experience working with electrical design drawings
Experience working in a GAMP 5 based validation model
Experience with Rockwell Automation PLC Control Systems
Experience debugging/working with custom machines
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO 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 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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