USA Sr. Validation Specialist
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Job Location:
Marion, IA - USA
Monthly Salary:
Not Disclosed
Posted on:
6 hours ago
Vacancies:
1 Vacancy
Job Summary
Description:
Max BR: BR
Job Title: Validation Specialist (Contract) KNEAT Gx
Industry: Pharmaceutical & Medical Devices
Contract Type: Contract (On site / Hybrid as required)
Duration: Contract basis (length defined by project needs)
Role Overview
The Validation Specialist (Contract) will support pharmaceutical and medical device operations by executing and maintaining compliant validation activities using Kneat Gx as the electronic validation lifecycle management system. This role is focused on hands on execution of validation deliverables to support equipment process utility and computerized system readiness in accordance with FDA ISO and cGMP requirements.
The specialist will work closely with Engineering Quality Automation IT and Operations to ensure systems and equipment are validated audit ready and capable of supporting safe compliant production.
Key Responsibilities
Validation Execution (Primary Role)
Execute IQ OQ PQ requalification and validation maintenance activities for pharma and medical device manufacturing systems.
Support validation of:
o Manufacturing and packaging equipment
o Utilities (compressed air clean utilities environmental controls)
o Computerized systems (automation data acquisition MES LIMS vision systems)
Apply risk based validation methodologies aligned with GAMP 5 and industry best practices.
KNEAT Gx Lifecycle Management
Author execute review and route validation documents within KNEAT Gx.
Maintain end to end traceability between:
o User Requirements (URS)
o Risk Assessments
o Test cases and protocols
o Deviations and final reports
Ensure proper use of KNEAT Gx workflows execution controls and electronic approvals.
Maintain compliance with 21 CFR Part 11 and data integrity expectations.
Deviation Change Control & CAPA Support
Document and investigate validation deviations within KNEAT Gx.
Support change control impact assessments affecting validated systems.
Participate in root cause analysis and CAPA implementation when required.
Regulatory & Quality Compliance
Ensure validation deliverables comply with:
o FDA cGMP regulations (21 CFR Parts 210/211 Part 11)
o ISO 13485 (Medical Devices)
o Internal Quality Management System (QMS) requirements
Support regulatory inspections and customer audits by providing validation documentation and responses.
Maintain validation documentation in a state of continuous inspection readiness.
Cross Functional Support
Collaborate with Engineering Quality IT Automation Manufacturing and external vendors.
Provide on floor support during commissioning troubleshooting and validation execution.
Support site initiatives such as new equipment introduction line upgrades remediation efforts and capacity expansions.
Preferred Qualifications
Experience supporting medical device manufacturing under ISO 13485.
Experience with automation and controls (PLC/SCADA) vision systems or MES.
Experience supporting high speed packaging or assembly lines.
Exposure to validation remediation or regulatory commitment work.
Core Competencies
Detail oriented with a strong compliance mindset
Ability to work independently under contract deliverables
Strong problem solving and root cause analysis skills
Effective communication with cross functional teams
Comfortable working in production and controlled environments
Work Conditions
On site support in a controlled GMP manufacturing environment
May require off shift or weekend support during execution windows
PPE and gowning requirements may apply depending on area
Supplier Spotlight Call Monday 5/4 10:30am CST. Please do not submit your candidates until after the call. If you could also join 5 minutes prior to the call I would appreciate it. Thank you for your support!
Microsoft Teams meeting
Join:
Meeting ID:
Passcode: Rr3Yd7v7
Need help System reference
Dial in by phone
1 # United States Waukegan
Find a local number
Phone conference ID:#
Join on a video conferencing device
Tenant key: *************
Video ID:
Job Title: Validation Specialist (Contract) KNEAT Gx
Industry: Pharmaceutical & Medical Devices
Contract Type: Contract (On site / Hybrid as required)
Duration: Contract basis (length defined by project needs)
Role Overview
The Validation Specialist (Contract) will support pharmaceutical and medical device operations by executing and maintaining compliant validation activities using Kneat Gx as the electronic validation lifecycle management system. This role is focused on hands on execution of validation deliverables to support equipment process utility and computerized system readiness in accordance with FDA ISO and cGMP requirements.
The specialist will work closely with Engineering Quality Automation IT and Operations to ensure systems and equipment are validated audit ready and capable of supporting safe compliant production.
Key Responsibilities
Validation Execution (Primary Role)
Execute IQ OQ PQ requalification and validation maintenance activities for pharma and medical device manufacturing systems.
Support validation of:
o Manufacturing and packaging equipment
o Utilities (compressed air clean utilities environmental controls)
o Computerized systems (automation data acquisition MES LIMS vision systems)
Apply risk based validation methodologies aligned with GAMP 5 and industry best practices.
KNEAT Gx Lifecycle Management
Author execute review and route validation documents within KNEAT Gx.
Maintain end to end traceability between:
o User Requirements (URS)
o Risk Assessments
o Test cases and protocols
o Deviations and final reports
Ensure proper use of KNEAT Gx workflows execution controls and electronic approvals.
Maintain compliance with 21 CFR Part 11 and data integrity expectations.
Deviation Change Control & CAPA Support
Document and investigate validation deviations within KNEAT Gx.
Support change control impact assessments affecting validated systems.
Participate in root cause analysis and CAPA implementation when required.
Regulatory & Quality Compliance
Ensure validation deliverables comply with:
o FDA cGMP regulations (21 CFR Parts 210/211 Part 11)
o ISO 13485 (Medical Devices)
o Internal Quality Management System (QMS) requirements
Support regulatory inspections and customer audits by providing validation documentation and responses.
Maintain validation documentation in a state of continuous inspection readiness.
Cross Functional Support
Collaborate with Engineering Quality IT Automation Manufacturing and external vendors.
Provide on floor support during commissioning troubleshooting and validation execution.
Support site initiatives such as new equipment introduction line upgrades remediation efforts and capacity expansions.
Preferred Qualifications
Experience supporting medical device manufacturing under ISO 13485.
Experience with automation and controls (PLC/SCADA) vision systems or MES.
Experience supporting high speed packaging or assembly lines.
Exposure to validation remediation or regulatory commitment work.
Core Competencies
Detail oriented with a strong compliance mindset
Ability to work independently under contract deliverables
Strong problem solving and root cause analysis skills
Effective communication with cross functional teams
Comfortable working in production and controlled environments
Work Conditions
On site support in a controlled GMP manufacturing environment
May require off shift or weekend support during execution windows
PPE and gowning requirements may apply depending on area
Supplier Spotlight Call Monday 5/4 10:30am CST. Please do not submit your candidates until after the call. If you could also join 5 minutes prior to the call I would appreciate it. Thank you for your support!
Microsoft Teams meeting
Join:
Meeting ID:
Passcode: Rr3Yd7v7
Need help System reference
Dial in by phone
1 # United States Waukegan
Find a local number
Phone conference ID:#
Join on a video conferencing device
Tenant key: *************
Video ID:
Additional Details
- Shore Options Available for this Position : Onshore Only
- Direct or Indirect : Indirect
- Time clock worker : No
- Shift : USA-1
