Tunnell Consulting Inc. Equipment Validation Specialist in Andover, Massachusetts

Equipment Validation Specialist

Job City: Andover

Job State: US - Massachusetts

Client Project Number: 8769

Description

Perform CIP and SIP Validation for new Filter Skids FS1095, FS1096 and FS1097 in PSB and Suite B- to include CIP OQ, CIP PQ and SIP OQ.

Provide validation services including summary report generations for CIP paths described below.

Deliverables

CIP OQ testing for the new skids on CIP1036. The uneventful testing will include rinse water samples for TOC, Endo and Bio as well as verification that the target skids are dry upon completion per visual inspection SOP-15664.

Testing will include performance of routine NWP and Storage.

CIP PQ testing for the new filter skids on CIP1036.

SIP OQ testing for the new filter skids docked onto UF1037.

Summary reports will be generated to document these deliverables.

  • SIP OQ summary report

  • CIPOQ summary report

  • CIP PQ summary report

Conditions for release:

New filter carts will be conditionally released for use following SIP OQ summary report approval. Unconditional release will follow CIP PQ summary report approval.

Candidates should have experience with SIP and CIP system operation as well as GMP, BPE, GAMP, and other applicable industry standards.