Validation Engineer

Job Title: Project Validation EngineerJob Description

The Project Validation Engineer leads process validation activities for medical device manufacturing, ensuring that production processes, equipment, and automation systems are robust, compliant, and ready for release to production. This role combines hands-on work on the manufacturing floor with extensive documentation, protocol development, and collaboration across Quality, Manufacturing, and Engineering teams to support innovative, life-saving medical devices.

Responsibilities

• Develop, author, and execute validation documentation, including IQ/OQ/PQ protocols, process validation plans, procedures, reports, engineering studies, and risk-based documentation.
• Partner closely with Quality, Manufacturing, and Engineering teams to draft, review, execute, and obtain approval for all validation deliverables.
• Evaluate manufacturing processes to understand product requirements, process flow, critical parameters, risks, and validation needs, and translate these into clear validation strategies.
• Support PPV and PQ-related activities for existing process backlogs, new product lines, and process transfers to ensure smooth and compliant implementation.
• Ensure all validation documentation follows established templates, internal standards, and applicable regulatory requirements for medical devices.
• Support automation and equipment capital projects from concept through installation and validation, ensuring equipment is properly qualified and ready for production use.
• Maintain and administer validation records within the company's quality management system, including documentation in Agile and other relevant tools.
• Spend time on the manufacturing floor to observe processes, support validation execution, troubleshoot issues, gather data, and verify that processes operate as intended.
• Perform significant office-based work to develop protocols, analyze data, prepare reports, and manage quality system documentation related to validation activities.
• Support process readiness and release-to-production activities after validation execution and approval, ensuring all requirements are met before manufacturing ramp-up.
• Work in a hands-on manner with process and equipment when needed, including direct interaction with manufacturing, assembly, automation, and molding systems.
• Track and report project outcomes, savings, and key performance indicators (KPIs) to demonstrate the impact and effectiveness of validation efforts.
• Assist with validation of manufacturing equipment, assembly equipment, automation equipment, molding processes, and plastics-related processes as required.
• Prepare and execute validation documents to ensure all automated systems are validated (IQ/OQ/PQ) and fully compliant with 21 CFR Part 820 and other applicable standards before release to production.
• Ensure compliance with FDA Quality System Regulations (QSR) and relevant product-specific regulations and standards, including IEC and ISO requirements.
• Champion Lean, Six Sigma, and Design for Manufacturability (DFM/DFA) principles across internal and outsourced operations to improve efficiency and product quality.

Essential Skills

• Minimum of 3+ years of experience in medical device validation or process validation within a similar regulated industry.
• Bachelor's degree in Engineering or a related technical field.
• Strong background in medical device process validation and regulatory compliance, including IQ/OQ/PQ and 21 CFR Part 820.
• Experience working in the medical device field or another highly regulated manufacturing environment.
• Ability to complete complex technical reports and documentation clearly and accurately.
• Good computer skills, including proficiency with Excel for data analysis and documentation.
• Demonstrated ability to work hands-on with manufacturing processes and equipment while also managing detailed documentation.
• Experience with Agile documentation systems for managing validation records and quality documentation.
• Understanding of FDA QSR and relevant IEC and ISO standards related to medical devices.
• Experience with plastics processing or injection molding in a manufacturing environment.

Additional Skills & Qualifications

• Scrum methodology experience and familiarity with working in an Agile environment.
• Experience championing or applying Lean and Six Sigma methodologies to improve processes and reduce waste.
• Knowledge of Design for Manufacturability (DFM) and Design for Assembly (DFA) principles.
• Ability to collaborate effectively with cross-functional teams in Quality, Manufacturing, and Engineering.
• Strong analytical and problem-solving skills, with the ability to evaluate process risks and critical parameters.
• Clear written and verbal communication skills for drafting protocols, reports, and presenting validation outcomes.
• Willingness to travel occasionally to Mexico to support validation and process transfer activities, as needed.
• Interest in contributing to innovative, life-saving medical devices in a collaborative, growth-oriented environment where work has direct global impact on patient care.

Work Environment

This role is 100% onsite and combines both manufacturing floor and office-based activities, with approximately 30% hands-on work on the production floor and 70% focused on documentation, protocol development, review, and quality system administration. The position operates on a first-shift schedule, Monday through Friday, with some flexibility in hours. The environment includes interaction with manufacturing, assembly, automation equipment, and molding processes, as well as extensive use of computer-based tools for documentation and data analysis. Occasional travel to Mexico is preferred to support process validation and transfer activities. The culture emphasizes collaboration, continuous improvement, and a strong commitment to quality in support of innovative, life-saving medical devices.

Job Type & Location

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

Pay and Benefits

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)

Workplace Type

This is a fully onsite position in Noblesville,IN.

Application Deadline

This position is anticipated to close on Jul 31, 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.