Senior Computer Systems Validation Engineer at Ocular Therapeutix
Ocular Therapeutix · Bedford, United States Of America · Onsite
- Senior
- Office in Bedford
Ocular Therapeutix, Inc. (NASDAQ:OCUL) is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology, ELUTYX™. Ocular Therapeutix has built a robust product pipeline of drug delivery solutions developed to reduce the complexity and burden of the current standard of care and position itself to become a leader in the ophthalmic space.
Outside of the ophthalmic realm and behind the doors of our headquarters in Bedford, MA, we strive to build a strong culture where employees can flourish and achieve their career goals. We encourage out of the box thinking, cross-functional collaboration, and creativity.
Position Summary:
The Senior Computer Systems Validation Engineer will be responsible for ensuring GxP computerized systems, including both on premises and Cloud/Server based applications, are validated and controlled in compliance with industry standards and regulations. The CSV Engineer will be primarily responsible for validating manufacturing, laboratory, and enterprise computerized systems. Other responsibilities include drafting system documentation, conducting risk assessment, and providing validation lifecycle management.
Principal Duties and Responsibilities include the following:
- 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.
Qualification Requirements:
- 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 11and 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 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.
Working Conditions:
- Office Environment
- May be required to enter laboratory or GMP process areas donning proper gowning / lab coats or PPE such as safety glasses.
Ocular Therapeutix is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws regarding nondiscrimination. Ocular Therapeutix provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, or status as a veteran. For information on how Ocular Therapeutix collects, stores, and utilizes candidate information please see our privacy policy found at https://www.ocutx.com/privacy-policy/. For the Privacy Notice for California Job Applicants, please see CCPA Applicant Notice.
