1 year Valication Contractor Position

Job Description

Job Description

Support the Clinical Manufacturing Organization at the Malvern site of Johnson & Johnson Innovative Medicine.

Provide overall Validation support of the new Clinical Manufacturing Organization inclusive of manufacturing. Oversee and perform Risk Based C&Q activities following procedures on equipment and instruments.

Will perform the following duties but not limited to: Draft, Review, and Approval of CMMS Change Controls, Work Orders, Validation Forms, and Validation Protocols. Work on a team responsible for instruments undergoing AIQ and C&Q. Complete equipment/instrument lifecycle management forms. Assist with quality release paperwork. Draft/review/approve assessments, protocols, final reports, and standard operating procedures as required.

All activities will be executed under the direction Validation personnel.

-Experience Required:

* Knowledge of Equipment Lifecycle Management Process

* Validation/Qualification of GxP Lab Equipment and Process Equipment

* Review and approval of Standard Operating Procedures

* Computer System Validation and Data Integrity

* Change Management Process

* Navigating and recording documentation in electronic systems per Good Documentation Practices

* 5+ Years of Industry Experience

-Systems Experienced Preferred:

* Document Management Systems

* Change Control systems (such as TrackWise/Salesforce)

* SAP

*DeltaV, EMS, BMS, Green Button Go