Job 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: Senior Validation Engineer
Location: Bend, OR, 97703
Duration: 12 Months
Job Type: Temporary Assignment
Work Type: Onsite
Location: Bend, OR, 97703
Duration: 12 Months
Job Type: Temporary Assignment
Work Type: Onsite
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Summary
We are seeking an experienced Senior Specialist and Site DI Lead, Quality Assurance / Senior Validation Engineer to support commissioning and qualification (C&Q) and Computerized System Validation (CSV) activities within a pharmaceutical / biotechnology environment. The role focuses on ensuring compliance with GxP requirements, applicable regulations, and industry standards while promoting Data Integrity (DI), maintaining validation documentation, supporting inspections, and driving continuous improvement across site operations.
Responsibilities
- Support commissioning, qualification, and computerized system validation projects.
- Prepare, execute, review, and approve validation protocols, reports, and system lifecycle documentation.
- Collaborate with IT, Quality Control (QC), Automation, Quality Assurance (QA), and vendors to review and approve qualification and validation activities.
- Perform change management and risk assessments.
- Provide subject matter expertise and ensure consistent validation strategies for equipment, systems, computerized systems, and methods.
- Support system troubleshooting, staff training, investigations, root cause analysis, and corrective and preventive actions (CAPA).
- Participate in client and regulatory inspections.
- Promote Data Integrity awareness and support improvements in site Data Integrity maturity.
- Establish and facilitate Data Integrity forums to share best practices, review remediation activities, discuss training, and address potential Data Integrity risks.
- Conduct regular Data Integrity GEMBA walkthroughs.
- Generate, review, and approve controlled documents and records.
- Oversee validation activities, support problem resolution, and make decisions related to commissioning, qualification, and validation.
- Collaborate with stakeholders to resolve findings and reduce potential Data Integrity risks identified through assessments and gap analyses.
Required Skills and Qualifications
- Bachelor's degree in Science or a related discipline.
- Minimum of five years of experience in the pharmaceutical, biotechnology, or related industry, including at least two years in a Quality Unit.
- Experience in equipment and analytical instrument qualification.
- Experience with computerized systems validation (CSV).
- Working knowledge of GxP requirements, 21 CFR Part 11, EU GMP Annex 11, and relevant industry standards such as USP.
- Knowledge of commissioning, qualification, and validation processes, including validation documentation and system lifecycle management.
- Understanding of change management, risk assessments, Data Integrity principles, investigations, root cause analysis, and CAPA.
- Strong cross-functional collaboration, technical troubleshooting, documentation, and problem-solving skills.
- Ability to support regulatory inspections, validation oversight, and continuous improvement initiatives.
- Ability to wear personal protective equipment (PPE), perform occasional light lifting of less than 25 lbs, and travel as needed.
Numbers & Facts
| Location | Bend, OR |
| Industry | Computer/IT Services |
| Salary | $15–$53 |
| Company Size | 100 to 499 employees |
| Year Founded | 2009 |
| Website | http://www.tekwissen.com/ |
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.Skills
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