Validation Engineer

Validation Engineer

We are seeking a Validation Engineer to plan, execute and document facility, equipment and system validations to ensure they meet design and regulatory requirements. The role focuses on developing and executing DQ/IQ/OQ/PQ protocols, performing FAT and SAT activities, and partnering with engineering, quality and operations to maintain compliant, reliable manufacturing systems and continuous improvement initiatives using Lean Manufacturing principles.

Key Responsibilities

• Develop and review validation strategies, protocols and reports for equipment, processes and computerized systems (DQ/IQ/OQ/PQ).
• Plan, lead and execute Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT); coordinate third-party vendors as required.
• Perform execution of installation and operational checks, collect and analyze test data, and prepare final validation summaries and deviation reports.
• Collaborate with cross-functional teams (Engineering, Quality, Manufacturing, IT) to ensure validation requirements are understood and implemented.
• Maintain validation documentation in accordance with company procedures and regulatory requirements (GMP, FDA, ISO).
• Support change control, CAPA and qualification activities; evaluate impact of changes and lead re-validation when necessary.
• Conduct risk assessments, define acceptance criteria, and ensure traceability of requirements through testing.
• Drive continuous improvement by applying Lean Manufacturing tools to reduce waste and optimize validation and commissioning workflows.
• Support supplier qualification and FAT oversight for new equipment purchases; review vendor documentation and test protocols.

Qualifications

• Bachelors degree in Engineering (Mechanical, Electrical, Chemical, Biomedical, or related field) or equivalent experience.
• 3+ years of hands-on experience in equipment and process validation within regulated industries (pharmaceutical, biotech, medical device, or similar).
• Proven experience writing and executing DQ/IQ/OQ/PQ protocols and summary reports.
• Demonstrated experience planning and conducting FAT and SAT activities and working with external vendors.
• Working knowledge of regulatory and industry standards such as GMP, GAMP5, 21 CFR Part 820/11 and ISO standards relevant to manufacturing/quality.
• Familiarity with Lean Manufacturing principles and experience applying continuous improvement tools in validation or production environments.
• Strong technical skills with industrial control systems (PLCs, HMIs, SCADA) and computerized system validation (CSV) preferred.
• Excellent documentation, communication and problem-solving skills, with attention to detail and ability to manage multiple projects and stakeholders.
• Willingness to travel to supplier sites and manufacturing locations for FAT/SAT as required.

Benefits

• Medical insurance
• Dental insurance - employer paid
• Vision Insurance - employer paid
• Short and Long-term disability - employer paid
• Basic Life and AD&D - employer paid
• Voluntary Life insurance
• 401(k) with company contribution
• Pension plan
• Employee Stock Ownership Program (ESOP)
• Paid time off
• Wellness Reimbursement
• 8 paid holidays