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LanceSoft Inc logo

Validation Engineer

LanceSoft Inc

  • Vacaville, CA
  • 30+ days ago
  • $45–$51.93 Per Hour

Highlights

Maintains the company s right to operate, supply to patients, and cost-effectiveness by actively participating in continuous improvement projects. Sign documents for activities as authorized and described by Genentech policies, procedures, and job descriptions.

Numbers & Facts

LocationVacaville, CA
IndustryStaffing/Employment Agencies
Salary$45–$51.93 Per Hour
Company Size2,000 to 2,499 employees
Year Founded2000
Websitehttp://www.lancesoft.com/

Description


Job Overview




  • Schedule: Monday Friday, 8:00 AM 4:00 PM (includes a 30-minute unpaid lunch)




  • Location: 100% Onsite (5x/week)




Job Summary


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.


Duties


Technical 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 w ith vendors and other support g roups.




  • 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.





Job Requirements


Education




  • BS/BA degree (preferably in a relevant scientific discipline).




Experience (may vary depending on site size/scope)




  • 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 actio nable pl ans.







  • Takes responsibility, drives results, and achieves expected outcomes.




Work Environment / Physical Demands / Safety Considerations




  • Standard office environment






Job Sumary:
**** PLEASE INSERT JOB DESCRI...

Shift: ['cGMP Regulations', 'Equipment Qualification']

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About Company

We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc). 

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.

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