Senior Validation Engineer

The Senior Validation Engineer is responsible for providing technical leadership and execution support for validation activities required to achieve and maintain regulatory compliance in preparation for an NDA filing and commercial readiness. This role oversees validation efforts across process validation (PV), Process Performance Qualification (PPQ), facility and utility qualification, equipment qualification, computer system validation (CSV), automation/controls validation, and validation lifecycle management.

The Senior Validation Engineer ensures that all validation deliverables meet applicable regulatory requirements, internal quality standards, and inspection‑readiness expectations.

This position is based at our Northbridge, MA facility. We offer a hybrid work schedule.

Essential Duties and Responsibilities

* Lead the development, execution, and approval of Process Validation and PPQ protocols and reports, ensuring alignment with FDA, EMA, and ICH guidelines.

* Support the establishment and maintenance of a robust process control strategy and contribute to Continued Process Verification (CPV) planning.

* Plan, execute, and document facility, equipment, and utilities qualification activities, including IQ/OQ/PQ, in accordance with internal procedures and regulatory expectations.

* Lead and support Computer System Validation (CSV) activities following GAMP 5 and 21 CFR Part 11 requirements, including validation of automation and control systems.

* Ensure validation documentation is maintained in a state of inspection readiness, supporting internal audits, regulatory inspections, and pre‑approval inspection (PAI) preparation.

* Conduct validation lifecycle gap assessments, develop remediation plans, and drive closure of identified gaps.

* Contribute to the development, revision, and implementation of Validation Master Plans (VMPs), validation SOPs, risk assessments, and related quality system documentation.

* Collaborate cross‑functionally with Manufacturing, Quality Assurance, Engineering, MS&T, and Regulatory Affairs to ensure validation activities support operational and regulatory objectives.

* Provide subject matter expertise (SME) during audits, inspections, and technical discussions.

* Mentor junior validation staff and support training initiatives related to validation practices and compliance requirements.

Education Requirements

* Bachelor's degree in Engineering, Life Sciences, Pharmaceutical Sciences, or a related technical discipline required.

Experience Requirements

* Minimum 8-12 years of validation experience in the pharmaceutical, biotechnology, or related regulated industry.

* Demonstrated experience leading process validation and PPQ activities in support of NDA/BLA submissions or commercial product launches.

* Strong background in facility, equipment, and utilities qualification, including cleanroom environments and critical utilities (e.g., compressed gases, WFI, etc.).

* Hands‑on experience with CSV and automation validation, including PLC, SCADA, HMI, and data integrity compliance.

* Proven experience supporting regulatory inspections, including PAI preparation and response.

* Familiarity with applicable regulations and guidance, including FDA, EMA, ICH Q7/Q8/Q9/Q10/Q12, EU Annex 15, and data integrity principles.

Knowledge, Skills, and Abilities

* Strong understanding of validation principles, risk‑based approaches, and lifecycle management.

* Proficiency in technical writing, protocol development, and documentation review.

* Ability to interpret and apply regulatory requirements to validation strategies.

* Strong analytical and problem‑solving skills, including experience with statistical tools and process capability concepts.

* Excellent communication, organizational, and cross‑functional collaboration skills.

* Demonstrated leadership capability and ability to mentor junior staff.

* Ability to work independently in a fast‑paced, evolving environment.

Working Conditions

* Standard office and GMP manufacturing/cleanroom environments.

* Some travel may be required for vendor visits, FAT/SAT activities, or corporate meetings.

EyePoint is committed to fair and equitable compensation practices. The…