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About TSR:

TSR is a relationship-based, customer-focused IT and technical services staffing company.

For over 40 years TSR, Inc. and its wholly owned subsidiary, TSR Consulting Services, have prospered in the Information Technology staffing business, earning the respect of companies both large and small with well refined candidate screening, timely placement, and a real understanding of the right skill sets required by our clients.

Mission & Vision

We do not believe in building a vision around the company but building a company around our vision, which is simply;

Every employee’s voice matters, their effort is appreciated, and their talent is rewarded.

We challenge each employee daily, to raise the bar on how we treat our consultants and candidates. For far too long in this industry, candidates have been ghosted, lied to, or placed at a client and then forgotten about. Each day our staff works tirelessly at qualifying and placing, top talent with our clients, in a compassionate and caring manner.

Not every candidate is a match for the job, but every candidate and consultant will be treated with respect and professionalism.

Validation Engineer

Job Description

  • Type: Contract
  • Job #67478

Our client, a leading pharmaceutical company is hiring a Validation Engineer on a contract basis.

Work Location

Bothell, WA

Summary

The primary functions of this role will be to support Validation activities as they pertain to Jump in Bothell, WA. Qualification may include on-site equipment testing activities. The duties and responsibilities of the role are as follows:

• Support equipment qualification projects

o Work cross-functionally with Validation, Quality, and System Owner groups to manage IQ/OQ/PQ execution in accordance with project timelines.

o Complete all validation package documents (e.g., IQ/OQ/PQ, Summary Report, Traceability Matrices) including management of stakeholder review and approval.

o Develop lifecycle documents for new assets. This includes Configuration Specifications (CS) and User Requirement Specifications (URS).

• Support the Periodic Review and Requalification program as needed

o Complete Periodic Reviews and Requalification activities as needed

o Temperature mapping of temperature-controlled chambers using the Kaye Validator

• Support other Validation projects/deliverables as needed

o This includes but is not limited to: Technical assessments for equipment maintenance events or changes, cleanroom classification studies, EMPQ, etc.

 

Experience Required:

• Bachelors Degree in Engineering or Life Science

• 2+ years of experience in a cGMP Pharmaceutical/Biologics/Cell Therapy Manufacturing facility, preferably in Validation or other Engineering capacity.

 

Preferred Experience:

• Experience writing and executing IQ/OQ/PQ protocols and Summary Reports

• Experience with Cell Therapy equipment (e.g. Xuri Wave Bioreactors, temperature controlled chambers, etc)

• Experience with ValGenesis, Blue Mountain/Maximo/SAP, Trackwise or other Quality Record Management system.

• Temperature mapping experience, particularly with the Kaye Validator

 

 

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