Highlights
Experience (may vary depending on site size/scope) Experience in the pharmaceutical/biopharmaceutical industry, or an equivalent combination of education and experience. Maintains the company's right to operate, supply to patients, and cost-effectiveness by actively participating in continuous improvement projects.
Numbers & Facts
| Location | Vacaville, CA |
| Industry | Staffing/Employment Agencies |
| Company Size | 100 to 499 employees |
| Year Founded | 1990 |
| Website | http://www.sunrisesys.com/ |
Description
Job Title: Validation Engineer
Location: Vacaville, CA
Duration: 12 Month Contract
Position Summary
Knowledge / Skills / Competencies
Location: Vacaville, CA
Duration: 12 Month Contract
Position Summary
- Schedule: Monday Friday, 8:00 AM 4:00 PM (includes a 30-minute unpaid lunch) 100% Onsite (5x/week)
- With direct supervision, the candidate is responsible for the support and execution of QC laboratory equipment qualification activities while in full compliance with current cGMP regulations and Roche/Genentech 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.
- 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 Genentech policies, procedures, and job descriptions.
- Perform any other tasks as requested by Senior Management to support QC laboratory operations.
- Education: 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.
Knowledge / Skills / Competencies
- Possesses 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.
- Standard office environment
About Company
Sunrise Systems was founded in 1990 with a clear vision to deliver world-class staffing service solutions in all labor categories, including IT consulting and solutions; all with the commitment to provide service that exceeds expectations and become the most trusted name in the industry. More than two and a half decades later, we pride ourselves on being at the forefront of the staffing industry. Combining our deep industry expertise, insights, and global resources, we have partnered with our clients to connect them with top professionals across several different industries.
We provide cost-effective Managed Staffing Solutions, Information Technology and Information Technology Consulting Services to several Fortune 500 companies and U.S. Government agencies. We provide our clients with flexible engagement models and customized products that are budget and time specific. Understanding the challenges that every business faces, we offer our services either on-site at the clients' site or from one of our globally distributed technology centers. Our onshore and offshore development capabilities ensure that we excel at meeting customer requirements every single time.
Our collective business experience spans over two and a half decades and ranges from:
- Business, management, and technical fields
- Information technology consulting and software solutions.
- Providing strategic support for the development and long-term growth of new business ventures across several industries including but not limited to; accounting, banking, finance, and recruitment.
- Motivating technology staff and establishing partnerships with Fortune 500 companies
Sunrise Systems has a vast range of competence in:
- Design, development, and support of cloud-based solutions from simple to highly complexed
- Database administration of multi-platform applications, complex databases, and web-based environments that include all aspects of installation, planning, maintenance, and monitoring.
- Data processing and data migration
- Application re-engineering and platform migration
- Working with the Information Systems and end-user communities at all levels to resolve issues and establish consensus.