QA Validation Specialist 3
Sunrise Systems IncPortsmouth, NH
Automate your job search with Sonara.
Submit 10x as many applications with less effort than one manual application.1
Reclaim your time by letting our AI handle the grunt work of job searching.
We continuously scan millions of openings to find your top matches.
Overview
Remote
On-site
Job Description
Job Title: Equipment Validation Analyst Job ID: 26-03440 Location: Portsmouth, NH Duration: 6 Months Manager's insight:
- Role is Equipment Validation and Cleaning Validation
- Experience with Kneat is absolutely required. Experience with Ellab for Temp Mapping is a plus
- Manager is looking for candidates with Cleaning Val (CIP, COP, SIP). 95% of equipment is single-use, so the Cleaning Val is limited mostly to Media Hold/Media Fill. Cleaning Val is mostly drafting SOPs
- Other equipment includes Autoclaves, Parts Washers, and Storage equipment (cold and ambient). Looking for a worker to Build Equipment Requalifications in Kneat.
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 of 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 the Document Management System (DMS), TrackWise Quality System (Change Control, Deviation, CAPA)
- Perform other duties as assigned.
Contact: Sunny Rajput | sunny.r@sunrisesys.com | URL: www.sunrisesys.com
Automate your job search with Sonara.
Submit 10x as many applications with less effort than one manual application.
FAQs About QA Validation Specialist 3 Jobs at Sunrise Systems Inc
What is the work location for this position at Sunrise Systems Inc?
This job at Sunrise Systems Inc is located in Portsmouth, NH, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at Sunrise Systems Inc?
Employer has not shared pay details for this role.
What employment applies to this position at Sunrise Systems Inc?
The employer has not provided this information. This may be discussed during the hiring process.
What is the process to apply for this position at Sunrise Systems Inc?
You can apply for this role at Sunrise Systems Inc either through Sonara's automated application system, which helps you submit applications 10X faster with minimal effort, or by applying manually using the direct link on the job page.