Highlights
Our client is a leading biotechnology company that combines technological insight with world-class manufacturing, scientific expertise, and process excellence and helps their 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 | Vacaville, CA |
| Industry | Computer/IT Services |
| Salary | $40–$45 |
| 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 world-wide. Our client is a leading biotechnology company that combines technological insight with world-class manufacturing, scientific expertise, and process excellence and helps their 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: Laboratory Equipment Qualification Specialist
Location: Vacaville, CA - 95688
Duration: 12 Months
Job Type: Temporary Assignment
Work Type: Onsite
Summary
With direct supervision, the Laboratory Equipment Qualification Specialist / Validation Engineer is responsible for the support and execution of QC laboratory equipment qualification activities while in full compliance with current cGMP regulations and corporate principles, quality policies, standards, and core values. Maintains the company's right to operate, supply to patients, and cost-effectiveness by actively participating in continuous improvement projects.
Responsibilities
- Perform qualification of laboratory equipment in accordance with EQ policies, plans, and procedures.
- Coordinate with laboratory personnel to define qualification requirements.
- Author, review, and execute equipment qualification protocols.
- Coordinate equipment qualification activities with vendors and other support groups.
- Identify business, quality, and compliance gaps.
- Sign documents for activities as authorized and described by policies, procedures, and job descriptions.
- Perform any other tasks as requested by Senior Management to support QC laboratory operations.
Required Skills
- BS/BA degree, preferably in a relevant scientific discipline.
- Experience in the pharmaceutical/biopharmaceutical industry, or an equivalent combination of education and experience.
- Knowledge of cGMP or equivalent regulations.
- Minimum of two years' experience in Validation or equipment qualification is desired.
- Ability to make sound decisions about scheduling and managing priorities.
- Flexibility in problem-solving, providing direction, and work hours to meet business objectives.
- Strong verbal and written communication skills and the ability to influence at all levels.
- Capable of building trustful and effective relationships.
- Able to think strategically and translate strategies into actionable plans.
- Takes responsibility, drives results, and achieves expected outcomes.
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.