CSV Quality Engineer

• Support software lifecycle processes for non-product software in accordance with internal procedures and regulatory requirements.
• Ensure computerized systems and software used in support of manufacturing, quality management, and other GxP activities are developed, validated and maintained in compliance with applicable FDA, EU and other international regulations and ISO standards.
• Support quality risk assessment activities (e.g., system level risk assessment, functional risk assessment, change risk assessment) throughout the life cycle of computerized systems.
• Execute validation strategies and planning of validation activities; Oversee execution of validation activities for non-product computerized systems.
• Review and approve validation documentation including, but not limited to, risk assessments, validation plans, protocols (IQ/OQ/PQ), traceability matrices, and validation reports.
• Collaborate with IT, vendors, and functional departments to ensure systems are validated and maintained in their validated state.
• Maintain computer system inventory
• Ensure validation documentation are retained per the company's retention policy and retrievable.
• Participate in change control processes to assess impact upgrades and changes on validated systems; Oversee execution of change actions.
• Coordinate and execute periodic reviews of validated systems per defined schedule; support development of remediation plan, if needed.
• Support audits and inspections by providing validation documentation and subject matter expertise.
• Provide guidance on software assurance and CSV principles and procedures to cross-functional teams.
• Support data integrity initiatives and ensure Part 11/Annex 11 compliance of electronic records and electronic signatures.
• Additional responsibilities may be assigned as necessary to support the business.
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy:
Required Skills & Experience
• Bachelor's degree in Engineering, Computer Science, Life Sciences, or related field.
• 5+ years of experience in CSV and software assurance within the medical device, pharmaceutical, or biotech industry.
• Strong understanding of:
o 21 CFR Part 11, Part 820, ISO 13485, ISO 14971
o GAMP5 guidelines, FDA guidance on risk-based software validation and computer software assurance
• Proven Experience with software development lifecycle (SDLC) and Computer System Validation (CSV) documentation.
• Experience with equipment and software development, validation and deployment activities for Manufacturing and Laboratory equipment.
• Experience with validation and compliance of on-premises and cloud-based (SaaS) applications
• Experience with QMS software platforms (i.e. MasterControl, Veeva, TrackWise).
• Experience with ERP platforms (i.e. SAP, QAD) and other enterprise business applications supporting GxP processes
• Detail-oriented with strong communication, technical writing and audit readiness skills.
• Ability to simultaneously manage multiple, cross-functional, validation projects
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.