Requirements:
- 3 years performing validation activities.
- Experience in custom engineered solutions Medical Devices or Life Sciences is preferred.
- Experience working with electrical design drawings.
- Proficient in Microsoft Office.
- Experience working in a GAMP 5 based validation model.
- Excellent presentation skills and ability to mentor without direct authority.
- Ability to work in a team environment. Self-starter able to work with minimal guidance.
- Experience with Rockwell Automation PLC Control Systems is preferred.
- Experience debugging/working with custom machines is preferred.
Responsibilities:
- Provide validation experience and guidance during equipment design software design build debug and qualification phases of a project.
- Write overall project quality (validation scope) plans.
- Organize guide and write requirement specifications as necessary.
- Review qualification/requalification packages for completeness and accuracy sound rationale compliance with validation policies.
- Interface with internal and client validation and engineering teams to secure document approvals.
- Oversee and execute validation qualifications at our facility and at the customers site.
- Organize guide and write qualification plans and protocols as necessary.
- Work through validation documentation in a timely manner to meet project schedules.
- Create validation summary reports. Provide input to address validation deviations and/or change requests and identify qualification requirements to ensure compliance to systems current validated state and all cGxPs.
- Drive a quality approach into the organization change control and documentation for the equipment design software and documentation.
- Support all aspects of the Validation Life Cycle from design through operation and improvement.
- Develop pertinent document templates tailored to customer SOPs.
Regards
Mohammed ilyas
PH - or Text - or you can share the updated resume at com
Additional Information :
All your information will be kept confidential according to EEO guidelines.
Remote Work :
No
Employment Type :
Contract
Requirements:3 years performing validation activities.Experience in custom engineered solutions Medical Devices or Life Sciences is preferred.Experience working with electrical design drawings.Proficient in Microsoft Office.Experience working in a GAMP 5 based validation model.Excellent presentation...
Requirements:
- 3 years performing validation activities.
- Experience in custom engineered solutions Medical Devices or Life Sciences is preferred.
- Experience working with electrical design drawings.
- Proficient in Microsoft Office.
- Experience working in a GAMP 5 based validation model.
- Excellent presentation skills and ability to mentor without direct authority.
- Ability to work in a team environment. Self-starter able to work with minimal guidance.
- Experience with Rockwell Automation PLC Control Systems is preferred.
- Experience debugging/working with custom machines is preferred.
Responsibilities:
- Provide validation experience and guidance during equipment design software design build debug and qualification phases of a project.
- Write overall project quality (validation scope) plans.
- Organize guide and write requirement specifications as necessary.
- Review qualification/requalification packages for completeness and accuracy sound rationale compliance with validation policies.
- Interface with internal and client validation and engineering teams to secure document approvals.
- Oversee and execute validation qualifications at our facility and at the customers site.
- Organize guide and write qualification plans and protocols as necessary.
- Work through validation documentation in a timely manner to meet project schedules.
- Create validation summary reports. Provide input to address validation deviations and/or change requests and identify qualification requirements to ensure compliance to systems current validated state and all cGxPs.
- Drive a quality approach into the organization change control and documentation for the equipment design software and documentation.
- Support all aspects of the Validation Life Cycle from design through operation and improvement.
- Develop pertinent document templates tailored to customer SOPs.
Regards
Mohammed ilyas
PH - or Text - or you can share the updated resume at com
Additional Information :
All your information will be kept confidential according to EEO guidelines.
Remote Work :
No
Employment Type :
Contract
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