Principal Commissioning/Validation Engineer III in Waltham, MA

Location: Waltham, MA (Fully onsite, local candidates only)

Duration: 06 months contract (+Chances of extension)

References will be required

Required Experience:

• Minimum BS degree in Engineering or a related field.
• 5–10 years of experience in validation and GMP environments.
• Experience with lab equipment, drafting, approving, and reviewing documents

Responsibilities Will Include

• Local Validation Program Maintenance
• QAV Documentation Review and Approvals for local and CMO's.
• CS Periodic Reviews planning and approvals
• QA GMP IT Support for DI and CS INF activities
• Validation and Metrology QMS events ownership as QAV (Change Control, CAPA & Deviation)
• QRFR's Generation
• Metrology Deliverables Review & Approval (forms or SOP's) + SAP Operation
• SME support on the GMP Equipment Calibration/ PM/ Breakdown assessment from QAV Technical perspective.

Validated Equipment Requalification, Modification/ Remediation/ Decommissioning

• Software Upgrade(s)
• Validation SME support for QMS Impact Assessments and Change Actions
• Validation Support for Risk Assessment on Equipment
• AdHOC Validation Support on Global Computerized Equipment Deployment.
• Serve as liaison and cross-functional lead with department likes QC, Manufacturing and Quality Assurance to provide an overall compliant Validation and QAV program with *** standards and GMP regulations.

The role will support the Validation, Metrology and QAV department in drafting, reviewing, approving documentation in conjunction with *** guidelines.

• URS
• Registration/ Calibration form
• SCCA forms
• Risk Assessment (for equipment with CSV)
• Configuration Spec. (for equipment with CSV or as applicable)
• Vendor qualification package (if purchased)
• Global/Digital CS System QAV Representation and deliverables approver.
• Internal Validation protocol
• Requirements Traceability Matrix
• Internal Final Report.
• Reports will be provided within client Quality Management System and email.
• Reports to channel through Quality Assurance Validation staff.

Rangam Consultants is a minority, women-owned, disability workforce solutions global organization. We specialize in attracting and retaining talent globally for rewarding careers in IT, Engineering, Scientific, Clinical, Healthcare, Administrative, Finance, Business Management, and many more, while integrating veterans and individuals with disabilities into the workforce. Indeed, we connect career aspirants to relevant job opportunities, whether in the USA, UK, India, or Ireland. Additionally, we offer Location Independent jobs and contract positions across different verticals and industries.
Rangam strives to put job seekers first, providing them with free access to search for jobs, post resumes, and research companies. Every day, we connect millions of people to new opportunities.