Senior Validation Engineer

Actalent; Littleton (CO); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading company in the medical device industry is seeking a Senior Validation Engineer for their facility in Littleton, CO. The role focuses on validating systems, executing validation plans, and ensuring compliance with FDA and GMP standards. Candidates should have at least 4 years of experience in validation engineering and a strong background in FDA regulations. This is a contract position with a competitive hourly rate and potential extension.

Benefits

Medical, dental & vision

401(k) Retirement Plan

Life Insurance options

Short and long-term disability

Health Spending Account (HSA)

Qualifications

• Minimum 4 years of experience in validation and quality engineering.
• Strong knowledge of FDA regulations and GMP.
• Proficiency in equipment qualification and process validation.

Responsibilities

• Validate multiple systems in a medical device manufacturing environment.
• Execute a validation Master Plan, including IQ, OQ, and PQ.
• Collaborate with cross-functional teams to ensure compliance.

Skills

Validation and quality engineering

FDA regulations knowledge

Proficiency in IQ/OQ/PQ

Job description

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Job Description

The Validation Engineer will play a crucial role in validating multiple systems within a medical device manufacturing environment. This individual will be responsible for executing a validation Master Plan, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) reporting and procedures. Additionally, the engineer will develop test and measurement methods.

Job Title: Validation Engineer

Job Description

The Validation Engineer will play a crucial role in validating multiple systems within a medical device manufacturing environment. This individual will be responsible for executing a validation Master Plan, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) reporting and procedures. Additionally, the engineer will develop test and measurement methods.

Responsibilities

• Validate multiple systems in a medical device manufacturing environment.
• Execute a validation Master Plan, including IQ, OQ, and PQ reporting and procedures.
• Create and develop test and measurement methods.
• Ensure adherence to FDA regulations and Good Manufacturing Practices (GMP).
• Collaborate with cross-functional teams to ensure compliance and quality standards.
  
  

Essential Skills

• Minimum 4 years of experience in validation and quality engineering within the medical device industry.
• Proficiency in equipment qualification (IQ/OQ/PQ) and process validation.
• Strong knowledge of FDA regulations and GMP.
• Experience with validation and quality engineering processes.
  
  

Additional Skills & Qualifications

• Experience with plastic injection molding machines or highly automated machines is preferred.
  
  

Work Environment

The work environment is within a medical device manufacturing facility, utilizing technologies such as plastic injection machines and automated systems. The role demands adherence to strict quality standards and compliance with regulatory requirements. The dress code is professional, aligning with industry standards. This is a contract for the next 6 to 9 months with potential to extend.

Pay and Benefits

The pay range for this position is $60.00 - $75.00/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 Lakewood,CO.

Application Deadline

This position is anticipated to close on Jun 2, 2025.

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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

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 due to a disability, please email [e-mail] for other accommodation options.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Quality Assurance

• Industries

  Business Consulting and Services

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