Equipment Validation Analyst - Portsmouth, New Hampshire

Job Location: Portsmouth, New Hampshire 03801
Duration: 6 months contract with possible extension or full time conversion

About the role

Equipment validation and Cleaning Validation. Experience with Kneat is absolutely required. Experience with Ellab for Temp Mapping is a plus. The role involves building Equipment Requalifications in Kneat and providing subject matter expert support to Quality Control, Manufacturing, and other departments for equipment design, operation, and troubleshooting.

Responsibilities

• Drive and own validation plans and execution of equipment changes and process improvements.
• Execute Installation Qualifications (IQ) and Operational Qualifications (OQ), and draft Performance Qualifications (PQ) as required.
• Perform Equipment Validation activities, including Validation Maintenance, Quality Systems review, and requalification to ensure GMP equipment remains in a validated state.
• Program, organize, and maintain Validation equipment and supplies, including dataloggers and probes.
• 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) and TrackWise Quality System (Change Control, Deviation, CAPA).
• Perform other duties as assigned.

Requirements

• Experience with Cleaning validation (CIP, COP, SIP).
• Experience with Kneat (required).
• Experience with Ellab for Temp Mapping (a plus).
• 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.

Equipment Focus

• 95% of equipment is Single Use, so Cleaning validation is limited mostly to Media Hold/Media Fill.
• Other equipment includes Autoclaves, Parts Washers, and Storage equipment (cold and ambient).
• Cleaning validation primarily involves drafting SOPs.

Pay

$75/hr - $85/hr