Senior Validation Engineer - 171296

Senior Validation Engineer

To be considered for an interview, please make sure your application is full in line with the job specs as found below.

Position Summary

We are seeking a hands-on Senior Validation Engineer to lead the planning, development, execution, and lifecycle maintenance of equipment and process validation activities within a regulated manufacturing environment. This position will support manufacturing processes and equipment, lead IQ/OQ/PQ activities, collaborate with cross-functional teams, and drive continuous improvement through data-driven problem solving.

Key Responsibilities

• Lead validation activities for manufacturing processes, equipment, and supporting systems.
• Develop and execute validation documentation, including Validation Plans, URS, risk assessments, IQ/OQ/PQ protocols and reports.
• Coordinate shop-floor execution of validation protocols, including resources, sampling, instrumentation, and testing.
• Establish and evaluate critical process parameters, control limits, and process capability using DOE, MSA, SPC, and capability analysis.
• Analyze manufacturing and validation data to identify trends and opportunities for improvement.
• Lead root cause investigations, CAPA activities, and process improvement initiatives.
• Support equipment qualifications, process changes, equipment transfers, and engineering changes while maintaining the validated state.
• Partner with Manufacturing, Quality, Engineering, and other cross-functional teams on validation and process improvement activities.
• Support improvements to quality systems, procedures, work instructions, and validation workflows.
• Ensure appropriate data integrity and documentation practices within computerized systems.
• Provide technical guidance and mentorship to engineers and technicians on validation practices, documentation, and statistical methods.

Qualifications

• Bachelor's degree in Engineering, such as Mechanical, Manufacturing, Industrial, Biomedical, or a related field.
• 6+ years of validation experience within a regulated manufacturing environment such as medical device, pharmaceutical, or combination products.
• Strong experience with IQ/OQ/PQ and validation lifecycle activities.
• Knowledge of cGMP, ISO 13485, 21 CFR 820, and Part 11; familiarity with GAMP 5 and risk-based validation is preferred.
• Experience developing sampling strategies, acceptance criteria, and validation test methods.
• Strong understanding of DOE, MSA/Gage R&R, SPC, and process capability analysis.
• Experience using Minitab or similar statistical software.
• Strong technical writing, documentation, and data integrity skills.
• Experience with process/equipment qualifications, automated manufacturing, or cleanroom environments is preferred.
• Strong communication skills with the ability to work effectively across cross-functional teams. xhyhwjd

Work Environment: This is an on-site position supporting manufacturing and validation activities directly on the production floor.