What are the responsibilities and job description for the Manufacturing Equipment Qualification (IQ/OQ/PQ) Engineer position at capgemini?
The Qualification Program (IQ/OQ/PQ) Administrator is responsible for overseeing the installation, operational, and performance qualification of equipment and systems in compliance with regulatory standards. This role ensures that all equipment operates within specified parameters and meets quality and safety requirements.
Verify that equipment is installed according to manufacturer specifications 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 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.
Conduct tests to ensure the equipment consistently performs according to specifications.
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.
Stay updated on changes in regulations and adjust qualification protocols accordingly.
Develop and conduct training programs for staff on IQ/OQ/PQ procedures and protocols.
Promote awareness of qualification processes within the company.
Implement monitoring systems to ensure adherence to qualification protocols.
Conduct regular internal audits to identify areas for improvement and ensure compliance.
Maintain detailed records of all qualification activities, including protocols, test results, and corrective actions.
Ensure documentation is accurate and easily accessible for regulatory inspections."
Key Responsibilities:
Establish the requirements (IQ)
Approval of the Protocol (IQ)
Execution of the IQ
Documentation of IQ Protocol
Post protocol review
Complete the IQ
Summary of IQ activities
Initiate and review OQ requirements
Approval of OQ Plan
Execution OQ and Test Plan
Completion and Verification of Training OQ
Verification of Equipment OQ
Deviation Identification OQ
Record and Resolve Deviation OQ
Re-execute Failed Portion of OQ
Documentation of OQ Protocol
Completion of all OQ Requirements
OQ Protoccol review approval
Creation of Quality Summary Report (IQ/OQ)
Initiate and Review PQ requirements
PQ Plan approval
Executing the PQ Protocol
Process Verification PQ
Completion and verification of PQ training
Deviation Identification PQ
Record and Resolve Deviation
Re-execute Failed Portion of PQ Protocol
Completion of the PQ
Quality Approval PQ
Stakeholders Approval PQ
Qualifications:
Bachelor’s degree in engineering, Life Sciences, or a related field.
3-5years of experience in equipment qualification or 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 $30.05/hour - $46.95/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.
Salary : $30 - $47