QualificationValidation Engineer
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Job Location:
Phoenix, NM - USA
Monthly Salary:
Not Disclosed
Posted on:
2 days ago
Vacancies:
1 Vacancy
Job Summary
Job Title: Qualification/Validation Engineer
Location: Phoenix AZ
Position Type: Contract
Duration: 6 / 12 Month
Work Type: Onsite
Rate: Pay range offered to a successful candidate will be based on several factors including the candidates education work experience work location specific job duties certifications etc.
Job Description:
Job Description:
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.
What are the Mandatory skills and skill proficiencies required for this position
Bachelors 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.
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.
What are the Mandatory skills and skill proficiencies required for this position
Bachelors 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.
ABOUT Ztek:
Ztek Consulting Inc is a minority- and woman-owned business enterprise that leverages a unique blend of human talent machine learning algorithms and artificial intelligence to provide customized talent management solutions for clients. Zteks diversity-focused hiring models have proven successful particularly in hiring veterans. The companys veteran-focused hiring and deployment program Z-V.E.T matches skilled veterans with clients needs in various areas.
Disclaimer:
Ztek is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Ztek is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race color religion or belief national origin citizenship social or ethnic origin sex age physical or mental disability veteran status marital status domestic partner status sexual orientation or any other status protected by the statutes rules and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment please contact us at Please indicate the specifics of the assistance needed. Ztek encourages all interested and qualified candidates to apply for employment opportunities. Ztek does not discriminate against applicants based on citizenship status immigration status or national origin in accordance with 8 U.S.C. 1324b.
