Validation Engineer

Noblesville, Indiana Manufacturing 8 days ago

Apply

Validation Engineer focused on qualification and validation activities for sterile pharmaceutical manufacturing equipment, utilities, and systems.

Job Requirements

  • 3+ years of validation experience in pharmaceutical or regulated manufacturing environments
  • 2+ years of experience supporting sterile processes
  • Experience with sterile manufacturing equipment, utilities, and systems
  • Experience with cleaning validation, HVAC, autoclaves, fill-finish lines, lyophilization, WFI, clean steam, and packaging systems
  • Experience with IQ, OQ, PQ, FAT, SAT, risk assessments, deviations, change controls, and validation lifecycle documentation
  • Knowledge of cGMPs, FDA, EU, ISO, USP, and related regulatory standards
  • Comfortable working in a radiopharmaceutical manufacturing environment
  • Ability to travel approximately 25% within the U.S. to support validation activities at multiple facilities

Preferred Skills

  • Bachelor’s degree in Engineering, Life Sciences, or related field
  • Experience with temperature mapping tools such as Kaye Validator, ValProbe, or Ellab
  • Familiarity with sterile manufacturing and packaging operations
  • Radiopharmaceutical experience

Job Responsibilities

  • Perform validation and qualification activities for sterile manufacturing equipment, utilities, and systems
  • Support cleaning validation activities for sterile manufacturing processes
  • Execute and document IQ, OQ, PQ, FAT, and SAT protocols
  • Support validation activities for HVAC, autoclaves, fill-finish lines, lyophilization, WFI, clean steam, and packaging systems
  • Develop and maintain validation lifecycle documentation
  • Conduct risk assessments related to equipment, utilities, processes, and systems
  • Investigate and document deviations related to validation activities
  • Support change control processes for validated systems and equipment
  • Perform temperature mapping and related studies using approved tools and procedures
  • Ensure validation activities comply with applicable cGMP, FDA, EU, ISO, USP, and related regulatory requirements
  • Travel to facility locations within the U.S. to support validation and qualification activities


Pay Details: $80,000.00 to $92,000.00 per year

Equal Opportunity Employer/Veterans/Disabled

Military connected talent encouraged to apply

To read our Candidate Privacy Information Statement, which explains how we will use your information, please

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:
  • The California Fair Chance Act
  • Los Angeles City Fair Chance Ordinance
  • Los Angeles County Fair Chance Ordinance for Employers
  • San Francisco Fair Chance Ordinance


Massachusetts Candidates Only: 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.

Apply

Equal Opportunity Employer/Veterans/Disabled
The Company will consider qualified applicants with arrest and conviction records.

  • Flex your reach.

    When you work with us, you gain access to our expansive network of top companies that are searching for engineering and technical talent just like you.

  • Leverage our reputation.

    Sometimes it's not about what you know, but who you know. And when you know us, you're getting your foot in the right doors, shaking the right hands, and landing in the right spots.

  • Let us go to bat for you.

    We'll make sure your resume, interview techniques, and technical training and certification are in line to shine with your next potential employer. We know what they're looking for, and we know how to help you stand out.