Medical-Device Validation Engineer

Actalent; Fort Worth (TX); On-site; USD 55,000 - 83,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

PTO / Time Off

Job summary

Actalent in Fort Worth, TX is seeking a Validation Engineer to lead validation/qualification activities for manufacturing processes, equipment, and computerized systems in a regulated environment. You will plan, execute, and document validation work across IQ/OQ/PQ and support data analysis with robust documentation.

Ideal candidates have 4+ years in engineering/validation within medical device or related regulated industries, strong statistical skills, and experience with eQMS.

Qualifications

• Bachelor0s degree in Engineering or related technical discipline.
• Approximately 4+ years of engineering, validation, quality, manufacturing, or related experience in regulated industries.
• Hands-on experience performing or supporting equipment/process validation.
• Experience developing and executing IQ/OQ/PQ protocols and reports in a regulated environment.
• Knowledge of validation principles for equipment and processes.
• Ability to prepare and manage validation protocols, reports, risk assessments, and other technical documentation.
• Experience with statistical analysis and interpretation of validation data.

Responsibilities

• Support sustaining activities for existing products to ensure stable, compliant, and efficient manufacturing processes.
• Support R&D efforts for modified and new products and processes, helping to bring them to routine production.
• Understand customer needs and plan validation activities accordingly.
• Adhere to quality-system requirements in all validation work.
• Collaborate with cross-functional teams to support commercialization of changes.
• Plan, coordinate, execute, and document validation activities per regulatory expectations.
• Develop and maintain IQ/OQ/PQ protocols and reports.
• Prepare validation plans, protocols, reports, risk assessments, and test records with accuracy.
• Evaluate data using appropriate statistical methods to demonstrate process capability.
• Support validation of equipment, packaging, inspection systems, and related processes.
• Assess changes to determine validation needs and rationale.
• Support investigations and CAPAs related to validation.
• Provide ongoing validation support for existing manufacturing processes.
• Support validation of computerized systems within QMS and manufacturing.
• Participate in validation of software updates and configuration changes.
• Work with stakeholders to define system requirements and testing strategies.

Skills

Validation

GxP Compliance

Statistical Analysis

IQ/OQ/PQ

Documentation

Excel

eQMS

CSV

Cross-functional Collaboration

Project Management

Root Cause Analysis

Education

Bachelor0s degree in Engineering or related field

Tools

TMV

eQMS Tools

Job description

Actalent in Fort Worth, TX is seeking a Validation Engineer to lead validation/qualification activities for manufacturing processes, equipment, and computerized systems in a regulated environment. You will plan, execute, and document validation work across IQ/OQ/PQ and support data analysis with robust documentation.

Ideal candidates have 4+ years in engineering/validation within medical device or related regulated industries, strong statistical skills, and experience with eQMS.