Validation Equipment Specialist in West Chester Township, OH at Johnson Service Group

Date Posted: 10/14/2021

Job Snapshot

Job Description

JobID: 386822

A validation and quality assurance provider are looking to hire a Validation Equipment Specialist to support a new inspection line in Ohio. This unique group works to develop and blueprint a universally implemented validation process that reliably achieves quality, affordable and available healthcare products. This is a 9-month  assignment that could be extended.

The deliverables are the following:

Equipment:

• New Bonfiglioli CCIT Machine (400 vials per min)                            • New Conveyor

• New MS60 Seidenader Automatic Inspection Machine (400 vials per min)

• New Syntegon GLT Trayloader

Validation Deliverables/Support:

• SLIA review for CCIT                      • SLIA review for MS60               • SLIA review for GLT

• SLIA review for Conveyor             • URS review for CCIT               • URS review for MS60

• URS review for GLT                       • SRA review for Vial Inspection Line

• Specification review for CCIT (FS, SDS, HDS)              • Specification review for MS60 (FS, SDS, HDS)

• Specification review for GLT (FS, SDS, HDS)          • CCIT DQ         • MS60 DQ

• GLT DQ                • pFMEA collaboration and review for Vial Inspection Line

• Room Finish Qualification(s) for Pack 1 – may be more than 1 if needed in multiple phases

• Conveyor IOV: TBD       

• CCIT FAT: End March - Early April 2022

o Review vendor FAT, write FAT wrapper, FAT support

• CCIT SAT: Early May

o Review vendor SAT, write SAT wrapper, SAT support

• CCIT IOQ: Mid-End May

o Write IOQ and execute

• MS60 FAT: End May

o Review vendor FAT, write FAT wrapper, FAT support

• GLT FAT: End May

o Review vendor FAT, write FAT wrapper, FAT support

• GLT / MS60 Installation & SAT Start: Mid June

o Review vendor SAT, write SAT wrapper, SAT support for GLT

o Review vendor SAT, write SAT wrapper, SAT support for MS60

• GLT / MS60 IOQ: Late June

o Write IOQ and execute for GLT     o Write IOQ and execute for MS60

• All PQs & Integrated OQ: Early – Mid July

o CCIT PQ – write and execute         o MS60 PQ – write and execute

o GLT PQ – write and execute

o Integrated OQ of all equipment with Conveyor – write and execute

• PV support (3 runs): End July

• Commercial: End of July              • Trace Matrix for CCIT              • Trace Matrix for MS60

JSG has been named to three prestigious lists from Staffing Industry Analysts (SIA)’s: Largest Staffing Firms in the U.S., Largest Engineering Staffing Firms in the U.S., and Largest Staffing Firms in Canada.

Please contact Allen Mudalel at 610 828-7356 and email resume to amudalel@jsginc.com

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