Senior Validation Engineer

Summary:

Key Duties and Responsibilities:

General:

• As a subject matter expert in medical device validation, complete validation projects for Chemence’s medical device products in accordance with FDA and ISO regulations and best practices.
• Provide leadership, training, and advice related to validation, product design, process design, and equipment selection and implementation.
• Example projects include validating new production processes and equipment, scaling up existing processes, requalifying and reviewing existing processes and products, validating new products or configurations, qualifying components from new suppliers, and implementing corrective and preventive actions (CAPA) to ensure regulatory compliance.
• Use insights from engineering, operations, design, development, and validation activities to improve process quality and economics.

Validation Ownership and Subject Matter Expertise:

• Develop and author validation/qualification protocols, including DQ/IQ/OQ/PQ, lead execution of these protocols, and report results.
• Lead the execution of validation/qualification protocols for processes, equipment, facilities, and utility systems, performing hands-on work and directing others as needed.
• Oversee the work of Chemence employees, vendors, or contractors in executing validation and qualification activities.
• Develop and update procedures to ensure compliance with cGMP, GLP, FDA, and international regulations.
• Support the translation of critical process parameters and the process control strategy into focused validation plans.
• Participate in continuous improvement and CAPA activities.
• Generate and review documentation (SOPs, Protocols, Change Requests/Change Controls) to support validation activities.
• Ensure compliance with cGMP, industry standards, and approved SOPs for protocols, records, procedures, and change control documents.
• Create and oversee specifications for processes, equipment, and user requirements, and determine test methods for specification compliance.
• Develop and oversee validation policies and procedures, ensuring adherence to corporate QSR, ISO, GMP, and other regulatory standards.
• Utilize project management tools to lead and monitor validation work.
• Apply statistical tools as needed to support validation and pre-validation activities, collecting and reviewing validation data and generating exception reports as necessary.
• Serve on cross-functional teams as a validation expert during the design phase for new equipment, defining test plans to ensure validation requirements are included in design decisions.

Safety:

• Identify and escalate any activities that may cause harm or damage.
• Ensure all incidents, including minor and trivial accidents, are reported.
• Maintain a safe working environment for yourself and colleagues by following Chemence’s health, safety, environmental, and quality procedures.
• Comply with environmental requirements, including proper disposal of chemicals and other waste.
• Identify opportunities to enhance equipment and process safety.
• Ensure equipment and processes meet safety, health, and environmental regulations.

Communications and Teamwork:

• Mentor and train colleagues on validation methodologies, complex processes, and automated equipment.
• Represent the validation team on cross-functional teams (PMO, Maintenance, Operations, R&D, Regulatory, and Quality) for various projects.

Qualifications, Education, and Experience Required:

• Bachelor’s degree in Science/Engineering or a related Life Science field.
• 7+ years of FDA-regulated GMP experience, ideally in medical device manufacturing.
• Ability to quickly learn new technologies and applications necessary for understanding validation requirements.
• Working knowledge of quality and validation tools, including statistical analysis, technical writing, metrology and calibration, inspection and testing, Statistical Process Control (SPC), Failure Mode and Effects Analysis (FMEA), sampling principles, Acceptable Quality Level (AQL), process mapping, risk analysis, cause-and-effect diagrams, and Pareto analysis.
• Experience managing validation activities for new process qualifications, new supplier qualifications for existing components, and periodic validation reviews.
• Strong problem-solving skills, including root cause analysis and process improvement with automated manufacturing and process control equipment.
• Proficient in Windows MS Office applications (Excel, Word, Outlook, PowerPoint, Teams).
• Preferred: Six Sigma Black Belt, Certified Quality Engineer, or similar certification.

Language Skills:

• English required; bilingual (Spanish) is a plus.

Physical Demands:

• Ability to stand for long periods, frequently bend, reach, handle items, and work with fingers.
• Ability to lift and push up to 25 pounds.
• Ability to kneel and bend.

Work Environment:

• Non-temperature-controlled warehouse and production floor, temperature-controlled office.

Other Duties:

• Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

AAP/EEO Statement:

• CHEMENCE® provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.