Manufacturing Equipment Qualification Engineer

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:
1 Establish the requirements (IQ)
2 Approval of the Protocol (IQ)
3 Execution of the IQ
4 Documentation of IQ Protocol
5 Post protocol review
6 Complete the IQ
7 Summary of IQ activities
8 Initiate and review OQ requirements
9 Approval of OQ Plan
10 Execution OQ and Test Plan
11 Completion and Verification of Training OQ
12 Verification of Equipment OQ
13 Deviation Identification OQ
14 Record and Resolve Deviation OQ
15 Re-execute Failed Portion of OQ
16 Documentation of OQ Protocol
17 Completion of all OQ Requirements
18 OQ Protoccol review approval
19 Creation of Quality Summary Report (IQ/OQ)
20 Initiate and Review PQ requirements
21 PQ Plan approval
22 Executing the PQ Protocol
23 Process Verification PQ
24 Completion and verification of PQ training
25 Deviation Identification PQ
26 Record and Resolve Deviation
27 Re-execute Failed Portion of PQ Protocol
28 Completion of the PQ
29 Quality Approval PQ
30 Stakeholders Approval PQ

What are the Mandatory skills and skill proficiencies required for this position
Qualifications:
Bachelors 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.