Validation Engineer (Medical Device)

Job Description

The Validation Engineer leads the validation aspects of Equipment Capital projects, focusing on process improvements and supporting the development of solutions. This role is responsible for validating new equipment installations, ensuring seamless process transfer, and readiness for production.

Responsibilities

• Prepare and execute validation documents to ensure all automated systems and process improvements are validated (IQ/OQ/PQ) and comply with 21 CFR Part 820 and other applicable standards before release to production.
• Evaluate validation strategies to ensure quick and compliant transfer of processes and equipment to production.
• Maintain Agile documents related to processes and equipment, including SOPs, flow charts, electrical drawings, 2D/3D drawings, equipment parameter lists, and logic programs.
• Comply with FDA QSR and relevant product-specific regulations.
• Ensure operational and regulatory excellence.
• Lead validation activities tied to process changes, including creating, approving, and executing protocols from scratch.
• Support the implementation of new equipment and upgrades in collaboration with R&D and Quality teams in a highly integrated environment.
• Ensure all changes meet medical device validation and quality standards.
• Maintain strong communication across teams for alignment and issue resolution.
• Conduct validation including URS, FAT, SAT, IQ/OQ/PQ, and create instructional and quality handbooks.
• Assist in automation and equipment capital projects from concept to installation and validation.
• Engage in hands-on tasks involving processes and equipment when needed.
• Champion Lean, Six Sigma, and Design for Manufacturability principles across internal and outsourced operations.
• Use Scrum methodology to break large projects into milestones and conduct sprint planning and regular stand-ups.

Essential Skills

• Good computer skills, particularly with Excel.
• At least 3 years of experience in medical device or pharmaceutical engineering and validation.
• Bachelor’s degree in Engineering or similar field of study

Additional Skills & Qualifications

• Ability to complete complex reports.
• Fluency in Spanish.
• Experience with Agile documentation.
• Scrum methodology experience.

Work Environment

The role is 80-90% office-based with the remaining time on the manufacturing floor. First shift work hours. The environment is collaborative and growth-oriented, focusing on innovative, life-saving medical devices with a global impact on patient care.

This is a Contract to Hire position based out of Indianapolis, IN.

The pay range for this position is $48.08 - $55.29/hr.

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 Indianapolis,IN.

This position is anticipated to close on Jul 8, 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 actalentaccommodation@actalentservices.com 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.

Salary : $48 - $55