Validation Engineer 12775
Validation Engineer 12775
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Job Description
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.
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 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 customerfacing interactions such as audits and responses to validationrelated queries.
This is an onsite 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 crossfunctional teams to support equipment commissioning qualification and validation efforts.
- Lead validationrelated 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.
Requirements:
- Bachelors 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 problemsolving 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 problemsolving skills.
- Strong written and verbal communication skills.
- Detail oriented good organizational traits.
- Ability to work in a teamoriented environment.
- Masters 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::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 wellbeing. 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 technologydriven excellence in missioncritical 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 .
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 technologydriven excellence in missioncritical 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 .
Employment Type
Full-Time
