Equipment Validation Analyst QA Validation Specialist 3
Portsmouth, OH - USA
Job Summary
Title: Equipment Validation Analyst / QA Validation Specialist 3
Location: Portsmouth NH 03801
Duration: 6 Months with Possible extension
Shift: 1st Shift
JOB DESCRIPTION:
- Provide Subject Matter Expert support to Quality Control Manufacturing and other departments for the design operation and troubleshooting of equipment.
- Drive/own the validation plans and execution of equipment changes and process improvements.
- Execution of Installation Qualifications/Operational Qualifications and drafting Performance Qualifications as required.
- Perform Equipment Validation activities to include Validation Maintenance Quality Systems review and requalification to ensure GMP equipment is continuously maintained in a validated state.
- Program organize and maintain Validation equipment and supplies including dataloggers and probes.
- Demonstrate a general understanding of biopharmaceutical manufacturing equipment and validation procedures for Installation Verification (IV/IQ) Clean-In-Place (CIP) Steam-In-Place (SIP) Autoclaves Clean Utilities Shipping Validation Temperature Mapping Controlled Storage Rooms and Equipment.
- Develop validation protocols from plans and engineering documents.
- Provide basic technical support when reviewing and approving SOPs Protocols Change Controls Deviations CAPA etc.
- Perform assigned Quality Systems activities within Document Management System (DMS) TrackWise Quality System (Change Control Deviation CAPA)
- Perform other duties as assigned.
Why TalentBurst
At TalentBurst we deliver more than talent we deliver outcomes. We partner with you to move quickly and connect you to opportunities aligned with your skills and long term growth.
Backed by precision transparency and results we connect top talent with leading organizations through trusted partnerships.
We offer competitive compensation and comprehensive benefits including medical dental vision and retirement options.
TalentBurst is an equal opportunity employer committed to an inclusive and diverse workforce.
Required Experience:
IC