Validation Engineer

Ingersoll Rand is committed to achieving workforce diversity reflective of our communities. We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sex (including pregnancy), sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.

Job Overview:



The Validation Engineer actively supports pharmaceutical containment manufacturing and ensures that equipment, systems, and processes comply with regulatory standards and company policies. This role requires the development, execution, and maintenance of validation protocols to ensure operational excellence and compliance with cGMP standards. The Validation Engineer will identify opportunities for process improvements and support continuous improvement initiatives. The role may also involve customer-facing interactions such as audits and responses to validation-related queries.

This is an on-site floor support position. Typical hours are 8 am - 5:00 pm M - F.

Responsibilities:

• Develop and execute validation protocols (IQ, OQ, PQ) for equipment, systems, and processes.
  
  
  
  
• Conduct risk assessments and gap analyses to ensure compliance with applicable regulatory standards.
  
  
  
  
• Author and maintain validation documentation, including protocols, reports, and supporting documentation.
  
  
  
  
• Perform periodic reviews of validated systems and revalidation activities to maintain a state of control.
  
  
  
  
• Troubleshoot equipment and processes to resolve validation issues and ensure optimal performance.
  
  
  
  
• Collaborate with cross-functional teams to support equipment commissioning, qualification, and validation efforts.
  
  
  
  
• Lead validation-related investigations and contribute to CAPA development to address root causes.
  
  
  
  
• Stay current with regulatory guidelines and industry best practices to ensure alignment with applicable standards (e.g., ISO 9001:2015, ISO 13485:2016, 21 CFR Part 820, 21 CFR Part 211).
  
  
  
  
• Provide technical guidance and training to manufacturing and quality teams on validation processes and procedures.
  
  
  
  
• Contribute to continuous improvement initiatives by evaluating and implementing process improvements.
  
  
  
  

• Bachelor's Degree
  
  
  
  
• 3 years of relevant experience developing and executing validation protocols (IQ, OQ, PQ) in cleanroom and/or aseptic manufacturing environments
  
  
  
  
• Experience with CAPA, root cause analysis, and 8D problem-solving methods.
  
  
  
  
• Experience with regulatory and industry standards (ISO 9001:2015, ISO 13485:2016, 21 CFR Part 820, 21 CFR Part 211).
  
  
  
  
• Experience with Microsoft Office Suite and statistical analysis software.
  
  
  
  
• Experience with measurement, calibration, and test equipment.
  
  
  
  
  
  
  
  
• Experience with general safety and hygiene practices.
  
  
  
  
  
  
  
  

Core Competencies:

• Operating knowledge of Microsoft office software and other basic computer usage. Working proficiency with hand held computer (i.e. Smartphone, iPad) and network bases.
  
  
  
  
  

Preferences:

• Demonstrates strong analytical, problem -solving
  skills.
  
  
  
  
  
  
  
  
• Strong written and verbal communication skills.
  
  
  
  
  
  
  
  
• Detail oriented, good organizational traits.
  
  
  
  
  
  
  
  
• Ability to work in a team-oriented environment.
  
  
  
  
  
  
  
  
• Master's or advanced degree in Engineering or a related field.
  
  
  
  
  
• Six Sigma Green Belt or Black Belt certification.
  
  
  
  
  
• Familiarity with CAD or AutoCAD software.
  
  
  
  
  
• Mechanically inclined with strong troubleshooting aptitude.
  
  
  
  
  
• Knowledge of manufacturing methods, process & quality standards (ISO 9001:2015, 13485:2016, 21cfr820, 21cfr211).
  
  
  
  
  
  
  
  

Travel & Work Arrangements/Requirements

This position will be based at our corporate offices in Durham and Lillington, NC.

What we Offer

At Ingersoll Rand, we embrace a culture of personal ownership - taking responsibility for our company, our communities, and our environment, as well as our individual health and well-being. Our comprehensive benefits package is designed to empower you with the tools and support necessary to take charge of your health, ensuring that together, we can continue to make life better. Our range of benefits includes health care options like medical and prescription plans, dental and vision coverage, as well as wellness programs. Additionally, we provide life insurance, a robust 401(k) plan, paid time off, and even an employee stock grant, among other offerings. These benefits are our commitment to you, so you can be your best at work and beyond.

Ingersoll Rand Inc. (NYSE:IR), driven by an entrepreneurial spirit and ownership mindset, is dedicated to helping make life better for our employees, customers and communities. Customers lean on us for our technology-driven excellence in mission-critical flow creation and industrial solutions across 40+ respected brands where our products and services excel in the most complex and harsh conditions. Our employees develop customers for life through their daily commitment to expertise, productivity and efficiency. For more information, visit www.IRCO.com.