ZipRecruiter

Log In

1

Sr Validation Engineer Jobs in Indiana (NOW HIRING)

Performance Validation

Senior CSV Engineer

Indianapolis, IN · On-site

$110 - $160/hr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Certain positions at Performance Validation are designated as safety sensitive based on job duties ... About the Job Performance Validation is seeking a Senior CSV Engineer to join our Indianapolis team.

PM Group

CSV Engineer I

Indianapolis, IN · On-site

$68K - $88K/yr

The CSV Engineer will work under the guidance of senior CSV team members to execute and document validation activities, support deviation resolution, verify system functionality against approved ...

PM Group

CSV Engineer I

Indianapolis, IN · On-site

$68K - $88K/yr

The CSV Engineer will work under the guidance of senior CSV team members to execute and document validation activities, support deviation resolution, verify system functionality against approved ...

Carrier

Validation Technician

Fort Wayne, IN · On-site

$35K - $71K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Execute test procedures and validation plans under the guidance of senior technicians or engineers. * Set up test equipment, instrumentation, and test environments according to defined instructions.

previous page

Showing results 41-60

All JobsSr Validation Engineer JobsSr Validation Engineer Jobs in Indiana

Sr Validation Engineer information

See Indiana salary details

$33

$61

$94

How much do sr validation engineer jobs pay per hour?

As of Aug 18, 2026, the average hourly pay for sr validation engineer in Indiana is $61.64, according to ZipRecruiter salary data. Most workers in this role earn between $49.18 and $70.00 per hour, depending on experience, location, and employer.

What is a Sr validation engineer?

Sr Validation Engineers are experienced professionals responsible for ensuring that products, systems, or processes meet regulatory standards and function as intended. They lead validation projects, develop protocols, oversee testing, and document results to confirm compliance with industry regulations, such as those from the FDA or ISO. Their work is essential in industries like pharmaceuticals, biotechnology, and manufacturing, where product quality and safety are critical. Senior validation engineers also mentor junior staff and help improve validation processes within their organizations.

What are the key skills and qualifications needed to thrive as a Sr validation engineer?

To thrive as a Sr Validation Engineer, you need a solid background in engineering or life sciences, extensive experience with validation protocols, and a strong understanding of regulatory standards such as FDA, GMP, or ISO. Expertise in using validation software, risk assessment tools, and familiarity with documentation management systems is typically required, along with certifications like Six Sigma or ASQ CQE being advantageous. Exceptional problem-solving abilities, attention to detail, and effective communication skills help you lead teams and interact with cross-functional departments. These competencies are crucial for ensuring products and processes meet compliance standards, maintain quality, and support organizational success.

What are some common challenges a Sr validation engineer faces when managing multiple validation projects simultaneously?

A Sr Validation Engineer often manages several validation projects at once, which can present challenges such as coordinating timelines, ensuring compliance with regulatory standards, and balancing cross-functional communication. Keeping detailed documentation and staying organized are essential, as unexpected equipment issues or shifting project priorities may arise. Successful engineers proactively communicate with quality, manufacturing, and R&D teams to mitigate risks, maintain project momentum, and deliver results within required deadlines.

What is the difference between Sr Validation Engineer vs Validation Engineer?

AspectSr Validation EngineerValidation Engineer
Required CredentialsBachelor's/Master's in Engineering, certifications like CQE or ASQ, experience in validation processesBachelor's in Engineering or related field, some certifications preferred, less experience required
Work EnvironmentPharmaceutical, biotech, or manufacturing industries; leading validation projectsSupporting validation tasks under supervision, often in similar industries
Employer & Industry UsageUsed by companies requiring compliance with FDA, ISO, or GMP standardsCommonly used in manufacturing and quality assurance roles

The main difference between a Sr Validation Engineer and a Validation Engineer lies in experience, responsibility, and expertise. The Sr Validation Engineer typically leads validation projects, has more advanced certifications, and plays a strategic role in compliance. Validation Engineers support validation activities and often work under supervision. Both roles are essential in regulated industries like pharmaceuticals and manufacturing, but the senior role involves greater leadership and technical oversight.

What are popular job titles related to Sr Validation Engineer jobs in Indiana?

For Sr Validation Engineer jobs in Indiana, the most frequently searched job titles are:

What job categories do people searching Sr Validation Engineer jobs in Indiana look for?

The top searched job categories for Sr Validation Engineer jobs in Indiana are:

What cities in Indiana are hiring for Sr Validation Engineer jobs?

Cities in Indiana with the most Sr Validation Engineer job openings:

Sr Validation Engineer jobs near you
Infographic showing various Sr Validation Engineer job openings in Indiana as of August 2026, with employment types broken down into 90% Full Time, 6% Part Time, and 4% Contract. Highlights an 86% Physical, 5% Hybrid, and 9% Remote job distribution, with an average salary of $128,201 per year, or $61.6 per hour.

Senior Quality Process Validation Specialist

INCOG BioPharma Services

Fishers, IN • On-site

Full-time

Re-posted 3 days ago

Job description

Description
The Senior Quality Process Validation Specialist provides QA oversight of Process Design (Stage 1), Process Performance Qualification (Stage 2), and Continued Process Verification (Stage 3) activities across the site. This role is responsible for ensuring validation protocols, risk assessments, PPQ studies, and CPV programs meet applicable regulatory expectations and internal procedures, while taking direct, hands-on ownership of protocol design, execution, lifecycle documentation, and ongoing process monitoring.
Essential Job Functions:
  • Provide QA oversight and approval of process validation activities of aseptically filled drug product across all three stages of the process validation life cycle, including Process Design, Process Performance Qualification (PPQ), and Continued Process Verification (CPV).
  • Review and approve process validation life cycle documents including risk assessments, process flow diagrams, critical process parameter (CPP) and critical quality attribute (CQA) identification, validation protocols, and summary reports.
  • Ensure all process validation activities are performed in compliance with FDA, EMA, and applicable regulatory requirements, ICH guidelines (including ICH Q8, Q9, Q10, Q11, Q12), and internal SOPs.
  • Oversee process-related change controls to ensure appropriate revalidation assessments are performed, documented, and closed in a timely manner.
  • Participate in the development, review, and revision of process validation-related SOPs, policies, and guidance documents.
  • Serve as a QA subject matter expert during internal and external audits and regulatory inspections related to process validation activities.
  • Support deviation investigations and CAPA activities related to process validation, PPQ, and continued process verification; review and approve deviations associated with process validation
  • Maintain current knowledge of regulatory trends, guidance documents, and industry best practices related to process validation, including FDA's 2011 Process Validation Guidance, EU Annex 15, and ICH Q8-Q12.

Special Job Requirements:
  • Bachelor's degree in a science or engineering field (e.g., Chemistry, Biology, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, or related discipline).
  • Minimum of 5 years of experience in pharmaceutical, biopharmaceutical, or CDMO manufacturing with direct involvement in process validation activities.
  • Demonstrated hands-on experience in designing and executing process validation protocols, including Process Performance Qualification (PPQ) studies, for aseptically filled drug product.
  • Working knowledge of the three-stage process validation life cycle as defined in the FDA 2011 Process Validation Guidance, including Process Design, Process Performance Qualification, and Continued Process Verification.
  • Direct experience with critical process parameter (CPP) and critical quality attribute (CQA) identification, statistical process monitoring, and process capability analysis. Familiarity with NOR/PAR determination, and other process design and qualification using ICH Q8 methodology.
  • Thorough understanding of FDA, EMA, and ICH regulatory requirements and guidance documents applicable to process validation (e.g., FDA Process Validation Guidance, EU Annex 15, ICH guidances; PDA and ISPE Process Validation and Technology Transfer guidances).
  • Familiarity with technology transfer activities and the associated process validation requirements for new product introductions.

Additional Preferences:
  • Experience in a sterile injectable or aseptic manufacturing environment, particularly within a CDMO setting.
  • Experience with aseptic processing validation, including media fills, hold time studies, shipping validation, and container closure integrity testing.
  • Prior experience supporting regulatory inspections (FDA, EMA, Health Canada) or client audits related to process validation activities.
  • Working knowledge of statistical tools and software used for process capability analysis, control charting, and continued process verification trending (e.g., Minitab, JMP).
  • Experience authoring or reviewing Annual Product Quality Reviews (APQRs) or Product Quality Reviews (PQRs) as part of continued process verification programs.

Additional info about INCOG BioPharma Services:
At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.
If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.
INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.
By submitting your resume and details, you are declaring that the information is correct and accurate.

Apply