US_East | Manufacturing & Process Engineer_L

Position: US_East | Manufacturing & Process Engineer_L1
Description:

"Possible 3 Month CTH | No Fees | Do Not Re-Post| Confidential

TMR M
Role:
Qualification/Validation Engineer

Work location:

Phoenix , AZ
Background and Meet and Greet: MANDATORY

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?
"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 following details must accompany your submission:

First Name, Middle name, and Last Name:
City and State:
Open to Relocate?
Rate:
Availability:
Phone #:
Mobile #:
Email address:
Visa type:
Visa Expiration Date:
Hiring Status:

Mariana Zarate - ERM
Capgemini North America
Tel.: "

Additional Details

• Global Grade : A
• Named Job Posting? (if Yes - needs to be approved by SCSC) :
  No
• Remote work possibility :
  No
• Global Role Family : 61404 (P) Manufacturing & Process Engineering
• Global Technical Skills Family : 18611 (F) Product Engineering
• Local Role Name :
  Qualification/Validation Engineer
• Local Skills :
  Ashish Mhatre
• Languages
  
  Required:
  
  :
  English