Senior Quality Engineer, Computer System Validation (Csv)

The Sr Quality Engineer, Computer System Validation (CSV) is responsible for QA oversight of the validation and compliance of GxP-regulated computerized systems and any associated GMP equipment ensuring they are implemented, maintained, and retired in accordance with global regulatory requirements, industry standards, and internal procedures.

Primary responsibilities include, but are not limited to, the following:

Individual Responsibilities

GxP Systems & Applications

• Collaborate with IT and GxP system business owners to ensure internal CSV processes and procedures are aligned to GAMP 5, 21 CFR Part 11, EU Annex 11, ICH Q9 (risk management), ICH Q10 (PQS), and FDA's Computer Software Assurance (CSA) guidance.
• Serve as a team member to provide qualification expertise to CMC, Manufacturing Operations, Facilities, Quality Control and Engineering departments.
• Provide QA oversight for new system implementations, upgrades, integrations, cloud/SaaS solutions, and decommissioning activities.
• Experience validating GxP computerized systems, associated equipment (hardware) and digital platforms across laboratory, manufacturing, quality, ERP, or cloud-based environments
• Approve validation deliverables (validation/assurance planning, testing strategy, traceability, UAT, periodic review, and retirement/archival plan, risk assessments, protocols, reports).
• Ensure validated systems remain in a controlled state through change management, periodic review, requalification, deviation management, and CAPA.
• Serve as QA reviewer/approver of deviations, CAPAs, change controls and effectiveness checks.
• Collaborate with customers and internal stakeholders to define validation strategies, risk-based approaches, and compliant delivery models aligned with GxP expectations
• Review/approve comprehensive validation documentation, including validation plans, user and functional requirements, risk assessments, test scripts, and summary reports.
• Coordinate with vendors for maintenance, upgrades, and issue resolutions to minimize downtime.

Primary skills and knowledge required include, but are not limited to the following:

• Must have previous experience in Quality Assurance or Quality Engineering
• Must have previous experience with GAMP5 system validation and validation of associated equipment.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
• Strong experience with regulated laboratory and/or manufacturing systems
• Understanding of access control, security principles, and audit trail requirements in regulated environments.
• Ability to manage GxP system lifecycle activities including change control, deviations, CAPAs, and periodic reviews.
• Strong documentation skills with experience authoring and maintaining validation and technical support documentation.
• Effective communication and collaboration skills, with the ability to interface between technical teams, vendors, and business stakeholders.
• Strong analytical and problem-solving skills with the ability to troubleshoot complex system issues in a timely manner.
• High attention to detail and commitment to data integrity.
• Proven ability to lead medium-to-large projects, drive planning/controlling, and utilize tools like RCA, FMEA, and VSM.
• Experience supporting audits, inspections, supplier assessments, CAPA activities, data integrity initiatives, or compliance remediation programs is considered an advantage.

Level of Education Required:

• Bachelor's degree(Scientific or Engineering discipline, or other technical disciplines); master's degree a plus

Number of Years of Experience in the Function and in the Industry:

• Minimum of 8+ years experience in the pharmaceutical or biotechnology industry
• Must have 3+ years' experience in GxP computerized system validation and associated equipment within the pharmaceutical, biotech, or medical device industry.

EyePoint is committed to fair and equitable compensation practices. The salary offer is commensurate with EyePoint's compensation philosophy and considers factors including but not limited to education, training, experience, market conditions, criticality of the role and internal equity. 

The target salary range for this position is listed below:

Salary Range

$142,140—$179,220 USD

Envision Your Future

With the exciting energy of a winning culture and an exhilarating pace, we are an ophthalmology company committed to preventing blindness by developing and commercializing innovative therapeutics.

The collective power of our values influences everything we do, and everything we do for you.

Transformational Innovation

We exist to change our patients' lives through the power of sight. We are forward looking, embrace challenges with curiosity, and continuously seek to improve our products and ourselves by learning, problem-solving and pushing the limits of science and technology.

Unwavering Integrity

We recognize our responsibility to our patients, employees, and our community, and value the trust they put in us. We set a high ethical bar and expect responsible leadership at every level to ensure we serve those who matter most to us.

Compassionate Excellence

We believe that fun and excellence can coexist. We foster a culture where enjoying the work we do and caring for each other are as important as delivering exceptional outcomes.

Inclusive Collaboration

We strive to see through the eyes of others and work as one team. We appreciate one another's differences and perspectives, and ensure everyone feels valued, respected and encouraged to bring their ideas forward.

EyePoint is proud to be an equal opportunity employer. We believe that diversity and inclusion among our colleagues is critical to our success as a company, and we seek to recruit, develop, and retain the most talented people from a diverse candidate pool. All applicants will be considered for employment without attention to age, race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.