Highlights
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. 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.
Numbers & Facts
| Location | Portsmouth, NH |
| Industry | Computer/IT Services |
| Salary | $45–$55 |
| Company Size | 100 to 499 employees |
| Year Founded | 2009 |
| Website | http://www.tekwissen.com/ |
Description
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 Professional
Location: Portsmouth, NH 03801
Duration: 6 Months
Job Type: Temporary Assignment
Work Type: Onsite
Shift: 1st Shift
Location: Portsmouth, NH 03801
Duration: 6 Months
Job Type: Temporary Assignment
Work Type: Onsite
Shift: 1st Shift
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 mandatory.
- Experience with Equipment Validation and Cleaning Validation is required.
- Experience with Ellab for temperature mapping is preferred.
- 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 requalifications 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.
About Company
WE THE TEKWISSEN PEOPLE
TekWissen offers you a broader portfolio of services, industry-leading solutions, and the meaningful innovations that give you greater flexibility and speed to respond to market dynamics, reduced costs and risk to improve enterprise performance, and increased productivity to enable growth.
To keep pace with global market demands, TekWissen keeps its finger on the pulse of change. Our organized approach to guiding a project from its inception to closure. Managing projects is becoming more and more important as we enter the digital era. To cope with the pace that this transition demands, a method is required to manage projects so they can yield quality work, while incorporating efficient use of time and resources.
Project involves identifying which quality standards are relevant to the project and determining how to satisfy them.
It is important to perform quality planning during the Planning Process and should be done alongside the other project planning processes because changes in the quality will likely require changes in the other planning processes, or the desired product quality may require a detailed risk analysis of an identified problem. It is important to remember that quality should be planned, designed, then built in, not added on after the fact.
Capabilities and accomplishments in one TekWissen business enhance the opportunity for success in the others. Put simply, TekWissen's unique combination of attributes promotes success.