Validation Engineer
Validation Engineer
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Job Description
WeCare is seeking a Validation Engineer to support the development execution and documentation of validation protocols to ensure regulatory compliance and system reliability. The ideal candidate will be experienced in validation methodologies (IQ/OQ/PQ) FDA regulations and quality systems particularly within healthcare medical devices or pharmaceutical industries. You will work closely with Quality Assurance IT Regulatory Affairs and Operations teams to ensure systems and processes meet applicable standards.
Key Responsibilities
Develop and execute validation protocols (Installation Qualification Operational Qualification and Performance Qualification) for software systems medical equipment and processes.
Create and maintain validation documentation in accordance with FDA 21 CFR Part 11 GxP and ISO regulations.
Ensure compliance with internal quality management systems and external regulatory requirements.
Collaborate with cross-functional teams to define validation requirements and establish risk-based approaches.
Conduct system and process assessments to identify gaps or improvements needed for validation compliance.
Lead or support periodic re-validation activities and change control processes.
Review and approve validation deliverables such as test plans scripts summary reports and traceability matrices.
Maintain accurate validation records and support internal/external audits and inspections.
Provide training and guidance on validation processes to technical and non-technical teams.
Required Qualifications
Bachelors degree in Engineering Life Sciences Computer Science or related field.
Minimum of 3 years of experience in validation engineering within healthcare pharmaceutical or medical device industries.
Solid understanding of validation lifecycle and methodologies (IQ/OQ/PQ).
Familiarity with FDA regulations GxP 21 CFR Part 11 and ISO 13485/ISO 14971.
Experience validating clinical or healthcare-related software/systems is a plus.
Strong analytical problem-solving and documentation skills.
Excellent verbal and written communication abilities.
Proficiency with tools such as Microsoft Office electronic document management systems (EDMS) and validation tracking tools.
Preferred Qualifications
Advanced degree or additional certifications (e.g. ASQ Six Sigma Lean CSV certification).
Experience with automated testing tools and/or computer systems validation (CSV) for electronic health records (EHR) laboratory information systems (LIS) or manufacturing execution systems (MES).
Previous experience working in a fully remote and cross-functional environment.
Work Environment & Benefits
Remote Work: Fully remote role with flexible working hours based on project needs.
Compensation: Competitive salary based on experience.
Benefits Package:
Health dental and vision insurance
401(k) retirement plan with employer match
Paid time off (PTO) and holidays
Continuing education and professional development support
Technology allowance and home office setup assistance
Eligibility Requirements
Applicants must be U.S. Citizens or possess a valid U.S. Work Permit.
Must be able to pass background checks and comply with HIPAA and internal confidentiality standards
Employment Type
Full Time