Qualification/Validation Engineer

Qualification/Validation Engineer Capgemini - 3.7 Phoenix, AZ Job Details Contract $23.11 - $36.12 an hour 19 hours ago Benefits Health insurance Dental insurance Vision insurance Retirement plan Qualifications Regulatory compliance Data reporting

GMP HVAC

Equipment testing Data analytics tools Cross-functional collaboration FDA regulations Engineering validation Full Job Description Phoenix, AZ, United States (On-site) Contract (3 months 21 days) Published 20 days ago troubleshooting skills process validation regulatory compliance documentation & reporting Deviation management FDA regulations problem - solving analytical skills Perform equipment and HVAC Qualification activities as per company standard operating procedures and site requirements. Document the installation process, including utility connections, environmental conditions, and component verification. Ensure all necessary documentation, such as manuals and certificates, are available and complete. Develop and approve IQ & OQ protocols that outline the tests to be performed to verify equipment operation. Conduct tests to ensure the equipment operates according to predefined specifications under normal operating conditions. Document test results, any deviations, and corrective actions taken. Develop and approve PQ protocols that outline the tests to be performed to verify equipment performance under actual production conditions. Document test results, any deviations, and corrective actions taken. Ensure all qualification activities comply with local and international regulatory standards, such as FDA and cGMP guidelines.

Key Responsibilities:

Develop and conduct execution of

IQ/OQ/PQ

protocols. Assist external contractor for external testing and documentation Implement monitoring systems to ensure adherence to qualification protocols. Maintain detailed records of all qualification activities, including protocols, test results, and corrective actions. Ensure documentation is accurate and easily accessible for regulatory inspections.

Mandatory skills:

Bachelor's degree in engineering, Life Sciences, or a related field. 3-5years of experience in equipment qualification including HVAC validation in a regulated industry. Strong knowledge of

IQ/OQ/PQ

processes and regulatory standards. Excellent analytical and problem-solving skills. Strong communication and interpersonal skills. Experience with cGMP and FDA regulations. Proficiency in data analysis and reporting tools. Ability to work collaboratively with cross-functional teams. The pay range that the employer in good faith reasonably expects to pay for this position is $23.11/hour - $36.12/hour. Our benefits include medical, dental, vision and retirement benefits. Applications will be accepted on an ongoing basis. Tundra Technical Solutions is among North America's leading providers of Staffing and Consulting Services. Our success and our clients' success are built on a foundation of service excellence. We are an equal opportunity employer, and we do not discriminate on the basis of race, religion, color, national origin, sex, sexual orientation, age, veteran status, disability, genetic information, or other applicable legally protected characteristic. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law, including the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

Unincorporated LA County workers:

we reasonably believe that criminal history may have a direct, adverse and negative relationship with the following job duties, potentially resulting in the withdrawal of a conditional offer of employment: client provided property, including hardware (both of which may include data) entrusted to you from theft, loss or damage; return all portable client computer hardware in your possession (including the data contained therein) upon completion of the assignment, and; maintain the confidentiality of client proprietary, confidential, or non-public information. In addition, job duties require access to secure and protected client information technology systems and related data security obligations.