Equipment Validation Analyst

Overview:

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients worldwide. Our client is a leading biotechnology company that combines technological insight with world-class manufacturing, scientific expertise, and process excellence and helps its customers deliver new and innovative medicines that help treat a wide range of diseases. Our client specializes in pharmaceutical ingredients, bioscience, biopharmaceuticals, custom manufacturing, biotechnology, life science ingredients, nutrition, microbial control, agriculture, materials science, personal care, and cell and gene therapy.

Job Title: Equipment Validation Analyst

Location: Portsmouth, NH 03801

Duration: 6 Months

Job Type: Temporary Assignment

Work Type: Onsite

Shift: 1st Shift

Pay Rate: $45 to $55 Depending on experience

Summary

Seeking an Equipment Validation professional to support Quality Control, Manufacturing, and other departments by providing subject matter expertise for equipment design, operation, troubleshooting, validation, and process improvements. The role focuses on equipment validation, cleaning validation, equipment requalification, and maintaining GMP equipment in a validated state, with strong experience using Kneat. Experience with Ellab for temperature mapping is preferred.

Responsibilities

• Provide Subject Matter Expert (SME) support to Quality Control, Manufacturing, and other departments for the design, operation, and troubleshooting of equipment.
• Drive and own validation plans and execution for equipment changes and process improvements.
• Execute Installation Qualification (IQ), Operational Qualification (OQ), and draft Performance Qualification (PQ) protocols as required.
• Perform equipment validation activities, including validation maintenance, quality systems review, and equipment 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 validation plans and engineering documents.
• Provide technical support during the review and approval of SOPs, protocols, change controls, deviations, and CAPA documentation.
• Perform Quality Systems activities within the Document Management System (DMS) and TrackWise Quality System, including Change Control, Deviations, and CAPA.
• Perform other duties as assigned.

Required Skills

• Experience with Kneat is required.
• Experience with Ellab for temperature mapping is preferred.
• Experience with Equipment Validation and Cleaning Validation.
• Experience with Clean-In-Place (CIP), Clean-Out-of-Place (COP), and Steam-In-Place (SIP).
• Experience drafting SOPs related to cleaning validation.
• Experience building equipment requalification’s in Kneat.
• General understanding of biopharmaceutical manufacturing equipment and validation procedures, including, IV/IQ, IQ, Clean-In-Place (CIP), Steam-In-Place (SIP), Autoclaves, Clean Utilities, Shipping Validation, Temperature Mapping and Controlled Storage Rooms and Equipment
• Experience developing validation protocols from engineering documents and validation plans.
• Experience reviewing and supporting SOPs, protocols, change controls, deviations, and CAPA documentation.
• Experience working with Document Management Systems (DMS) and TrackWise Quality System (Change Control, Deviations, and CAPA).

TekWissen® Group is an equal opportunity/affirmative action employer (m/f/d/v) supporting workforce diversity.