Senior Validation Engineer

ZipRecruiter; Cleveland (OH); On-site; USD 80,000 - 110,000; Full time

Job summary

An established industry player is seeking a Senior Validation Engineer to lead equipment and process validation efforts for gene and cell therapy manufacturing. This role involves preparing protocols, managing validation projects, and ensuring compliance with regulatory standards. You will collaborate with various departments, author critical documentation, and drive process optimization initiatives. If you have a strong background in validation engineering and a passion for improving manufacturing processes, this is an exciting opportunity to make a significant impact in a dynamic environment.

Qualifications

• 8+ years of experience in Equipment and Process Validation Engineering.
• Strong knowledge of GLP, GDP, GCP, GMP regulations.

Responsibilities

• Oversee validation processes and ensure documentation compliance.
• Manage validation projects and supervise technicians and contractors.

Skills

Process Validation Engineering

Technical Writing

Regulatory Compliance

Analytical Skills

Project Management

Statistical Analysis

Education

Bachelor's degree in Engineering

Bachelor's degree in Life Sciences

Tools

Statistical Analysis Software

Document Processing Software

Project Management Tools

Job description

The Sr. Validation Engineer will provide specialized knowledge in developing strategies for equipment qualifications and process validations, including products and processes for gene and cell therapy manufacturing. Responsibilities include preparing protocols and reports, coordinating validation activities across departments, overseeing validation processes, and ensuring documentation compliance. The role also involves providing technical expertise for facility, equipment, and process qualification, authoring validation documents, executing validations, and overseeing contractors during validation activities. Additionally, the engineer will support the lifecycle of launched products, identify process optimization opportunities, and lead validations to ensure regulatory compliance.

Responsibilities

• Interface effectively with management in IT, Operations, Quality, Manufacturing, and other disciplines.
• Provide technical decision-making for validation strategies on complex projects.
• Create SOPs and training materials.
• Author and approve qualification plans, impact assessments, validation protocols, risk assessments, user requirements, validation reports, and other validation documents.
• Perform, coordinate, and manage qualification testing.
• Coordinate IQ, OQ, and PQ activities to ensure regulatory compliance.
• Identify areas for improvement and implement necessary changes.
• Review validation needs with equipment, method, and process owners/SMEs.
• Manage validation projects, supervising technicians, engineers, and contractors, providing leadership and guidance.
• Develop protocols using a risk-based approach aligned with regulatory requirements.
• Manage individual and team goals.
• Train staff in qualification and validation procedures and reporting.
• Maintain controlled documents within the company's document control system.
• Assist in FDA and other regulatory inspections.
• Support daily operational issues as needed.
• Engage in ongoing training and education.
• Perform other duties as assigned.

Requirements

• Bachelor's degree in Engineering or Life Sciences (Chemistry, Biology, Physics, etc.).
• 8+ years of experience in Equipment and/or Process Validation Engineering within a pharmaceutical or medical device company.
• Adaptability to changing priorities, well-organized, articulate, and strong writing skills.
• Experience qualifying process equipment and facilities in a pharmaceutical setting.
• Experience validating formulation and filling processes in cleanroom environments.
• Knowledge of GLP, GDP, GCP, GMP regulations, and relevant ISO standards.
• Proficiency with software supporting statistical analysis, document processing, flow charting, and project management.
• Understanding of manufacturing equipment and methods for gene and cell therapy products.
• Knowledge of calibration and preventive maintenance requirements.
• Computer literacy related to validation documentation and execution.
• Strong verbal and written communication skills.
• Ability to work independently and in teams, including with consultants and contractors.
• Analytical skills for investigating and addressing technical and regulatory issues.
• Ability to design, execute, and analyze validation studies.
• Capability to manage multiple tasks concurrently.
• Experience executing validation plans for gene and cell therapy products.