Ocular Therapeutix, Inc. · 12 hours ago
Sr. Computer Validation System's Engineer
Bedford, MA
Full-time
Onsite
Senior Level
$135K/yr - $145K/yr
7+ years expOcular Therapeutix, Inc. is a biopharmaceutical company focused on innovative therapies for eye diseases. They are seeking a Senior Computer Validation Systems Engineer responsible for validating GxP computerized systems and ensuring compliance with industry standards. The role includes drafting system documentation, conducting risk assessments, and managing validation lifecycle processes.
BiotechnologyHealth CareMedical Device
Responsibilities
Provide CSV and CSA-based compliance guidance to the IT function, system owners, and business stakeholders, applying a risk‑based approach focused on patient safety, product quality, and data integrity
Lead the development, harmonization, implementation, and adherence to CSV and CSA procedures, ensuring validation effort is commensurate with system risk, intended use, and GxP impact
Generate/Revise/Execute system life cycle deliverables using a risk‑based CSA methodology and GAMP 5 guidelines (including URS, SRS, FRS, DDS, RTM, User Acceptance testing, FAT, SAT, Validation Planning, IQ, OQ, PQ, Risk Assessments and Final Validation Summary Report as applicable)
Evaluate proposed new computerized systems and software to determine GxP impact, system criticality, and intended use, and define a CSA‑aligned validation strategy that balances compliance, efficiency, and business needs
Review and assess vendor‑supplied documentation and testing evidence, leveraging supplier activities where appropriate, and perform independent risk‑based verification to ensure compliance with internal requirements and regulatory expectations
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
Qualification
Required
Bachelor's degree in Engineering, Computer Science or related discipline
Must have 7+ years of CSV experience in an FDA regulated industry
Strong knowledge and understanding of current Good Manufacturing Practices (cGMP) and FDA 21 CFR Part 11 and EU Annex 11 regulations and standards
Understanding of data integrity requirements and how to perform assessments
Knowledge and experience with qualifying on premises and externally hosted (SaaS, PaaS, IaaS) software systems
Ability to work with and influence people at all levels in matters related to CSV, CSA 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
Preferred
Experience with systems like LabWare LIMS, MasterControl, SAP, Blue Mountain, Environmental Monitoring Systems (EMS), and IT infrastructure components
Company
Ocular Therapeutix, Inc.
Ocular Therapeutix, Inc. is a biopharmaceutical company committed to redefining the retina experience across drug development, treatment, and outcomes.
51-200 employees
H1B Sponsorship
Ocular Therapeutix, Inc. 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 (6)
2024 (1)
2023 (3)
2022 (4)
2021 (10)
2020 (3)
Funding
Current Stage
Public CompanyTotal Funding
$1.19BKey Investors
Ascension VenturesPolaris Partners
2025-09-30Post Ipo Equity· $475M
2024-02-22Post Ipo Equity· $325M
2023-12-13Post Ipo Equity· $115.11M
Leadership Team
Pravin Dugel
Executive Chair, President, and CEO
Michael Goldstein
Chief Strategy Advisor
Recent News
2026-01-24
2026-01-23
2026-01-23
Company data provided by crunchbase