Validation Engineer

Validation Engineer Medical Device Manufacturing (Dallas-Fort Worth)

Our client, a well-established medical device manufacturer in the Dallas-Fort Worth area, is seeking a Validation Engineer to support the development, qualification, validation, and ongoing optimization of manufacturing processes, equipment, software systems, and quality systems. This role will be responsible for planning and executing validation activities, including IQ/OQ/PQ protocols, analyzing validation data, preparing technical documentation, and ensuring compliance with regulatory and quality requirements. The Validation Engineer will collaborate closely with Quality, Manufacturing, Engineering, R&D, and Regulatory teams to support new product introductions, process improvements, equipment qualifications, computerized system validation (CSV), and continuous manufacturing support.

Key Responsibilities

• Develop, execute, and document equipment, process, and computerized system validation activities.
• Create and maintain IQ/OQ/PQ protocols, validation plans, reports, risk assessments, and supporting documentation.
• Evaluate validation data using statistical methods to demonstrate process capability and compliance.
• Support validation of manufacturing equipment, packaging systems, inspection systems, utilities, software applications, and eQMS platforms.
• Assess process, equipment, and software changes to determine validation and revalidation requirements.
• Support process improvements, troubleshooting, investigations, CAPAs, change controls, and quality system initiatives.
• Collaborate cross-functionally to transition new products, materials, and manufacturing processes into production.
• Maintain compliance with FDA, ISO 13485, data integrity, electronic records/signatures, and other regulatory requirements.
• Manage multiple validation projects while ensuring timelines, documentation quality, and stakeholder communication.

Qualifications

• Bachelor's degree in Engineering, Science, Biomedical Engineering, Mechanical Engineering, Chemical Engineering, Manufacturing Engineering, or related technical discipline.
• 2+ years of experience in validation, quality, manufacturing, or engineering within medical device, pharmaceutical, biotechnology, or other regulated industries.
• Experience with equipment and process validation, including development and execution of IQ/OQ/PQ protocols.
• Medical device manufacturing experience preferred.
• Strong technical writing, problem-solving, and cross-functional collaboration skills.

Preferred Technical Skills

• Process and equipment validation
• IQ/OQ/PQ protocol development and execution
• Computerized System Validation (CSV) and/or Computer Software Assurance (CSA)
• eQMS systems and validation documentation
• Statistical analysis and data interpretation
• Microsoft Excel and data analysis tools
• Electronic records and electronic signatures compliance
• Manufacturing equipment and software validation
• Automated inspection and vision systems
• Knowledge of FDA, ISO 13485, and regulated manufacturing environments

Ideal Candidate: A hands-on validation professional with experience supporting regulated manufacturing environments who can independently drive validation projects while partnering effectively with Quality, Operations, Engineering, and Regulatory teams.

This is a Contract to Hire position based out of Fort Worth, TX.

The pay range for this position is $40.00 - $60.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)

This is a fully onsite position in Fort Worth,TX.

This position is anticipated to close on Oct 19, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email View email address on click.appcast.io for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.