Ocular Therapeutix, Inc Senior Computer Systems Validation Engineer in Bedford, Massachusetts
The Computer Systems Validation Engineer will be responsible for ensuring GxP computerized systems, including Cloud/Server based applications, are validated and controlled in compliance with industry standards. The CSV Engineer will be primarily responsible for validating manufacturing, laboratory, and enterprise computerized systems. Other responsibilities include drafting system documentation, developing functional requirement specifications, and providing validation lifecycle management.
The position is set in a dynamic, fast-paced start-up environment and shall require the individual to work on a broad range of tasks.
Provide CSV compliance guidance to the IT function, system owners, and stakeholders.
Lead the development, harmonization, implementation and adherence to validation procedures related to computer systems validation.
Generate/Revise/Execute system life cycle deliverables (e.g., URS, SRS, FRS, DDS, RTM, User Acceptance testing, FAT, SAT, Validation Planning, IQ, OQ, PQ, Risk Assessments and Final Validation Summary Report)
Evaluate proposed new computerized systems or software to assess GxP impact and provide guidance on a risk-based validation approach, working with stakeholders to achieve business needs.
Review of vendor executed Computer system qualification documents to verify compliance with internal requirements.
Support change control activities, deviation resolution (CAPA), and effectiveness checks for computer systems.
Manage and execute decommissioning activities for retired or end of life systems.
Ensure that suppliers of IT services and solutions are properly assessed to determine their level of compliance and ensure that appropriate controls are in place based on risk.
Participate in project teams executing various validation projects and communicate project plans, status updates and progress against milestones to project team members.
Maintain up to date knowledge of evolving regulatory requirements regarding computer systems and act as an information resource for the team and business stakeholders.
Support internal and external audits and regulatory inspections.
Perform other validation engineering duties as assigned.
Bachelor’s degree in Engineering, Computer Science or related discipline.
Must have 5+ years of CSV experience in an FDA regulated industry.
Strong knowledge and understanding of current Good Manufacturing Practices (cGMP) and FDA 21 CFR Part 11and EU Annex 11 regulations and standards.
Understanding of data integrity requirements and how to perform assessments.
Knowledge and experience with qualifying in-house and externally hosted (SaaS, PaaS, IaaS) software systems.
Ability to work with and influence people at all levels in matters related to CSV and GxP compliance.
Demonstrated experience in successfully managing complex validation projects and maintaining validation requirements and timelines.
Understanding of quality systems such as change control and discrepancy investigations.
Experience working with IT for qualification of network and infrastructure.
Demonstrated written and verbal communication skills.
Proficient with Microsoft Office, particularly Word and Excel.
High degree of initiative and self-motivation.
Experience creating technical, written content.
Ability to mentor team members and colleagues.
Thorough understanding of network infrastructure and business systems preferred.
IT Project Management experience preferred.
Working Conditions: Office Environment
Will be required to enter laboratory or GMP process areas donning proper gowning / lab coats or PPE such as safety glasses.
External Company Name: Ocular Therapeutix, Inc.
External Company URL: http://www.ocutx.com/
Street: 15 Crosby Drive