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. 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.
Numbers & Facts
| Location | Houston, TX |
| Industry | Computer/IT Services |
| Salary | $35–$39 |
| 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: Pharmaceutical Validation Engineer
Location: Houston, TX - 77047
Duration: 6 Months
Job Type: Temporary Assignment
Work Type: Onsite
Shift: Monday to Friday - 1st Shift
Summary
The Pharmaceutical Validation Engineer / Validation Engineer II is responsible for developing and executing validation and CQV activities for equipment, utilities, facilities, and Controlled Temperature Units. The role supports cross-functional teams in ensuring compliance with cGMP, FDA, and ICH regulatory requirements within a pharmaceutical or biopharmaceutical manufacturing environment.
Responsibilities
- Develop and execute validation protocols and reports for equipment, utilities, and facilities, including IQ, OQ, and PQ.
- Develop and execute CQV deliverables for Temperature Mapping of Controlled Temperature Units.
- Coordinate validation activities with Manufacturing, Quality Assurance, Engineering, and R&D teams.
- Analyze validation data, identify deviations, and recommend Corrective and Preventive Actions (CAPAs).
- Prepare and present validation summaries and reports for internal and external audits.
- Participate in the review and approval of change controls related to validated systems.
Required Skills
- Bachelor's degree in Engineering (Chemical, Biomedical, Mechanical, or equivalent) or a related scientific discipline.
- 2-6 years of validation experience in the pharmaceutical or biopharmaceutical industry.
- Strong knowledge of cGMP, ICH guidelines, FDA regulations (21 CFR Parts 210, 211, and 820), and Other applicable regulatory requirements.
- Hands-on experience with Temperature Mapping for Controlled Temperature Units.
- Proven experience in Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Familiarity with FDA and cGMP compliance standards.
- Strong analytical, documentation, and cross-functional collaboration skills.
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.Similar Job Searches
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