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

Location	Vacaville, CA
Industry	Staffing/Employment Agencies
Salary	$45–$51.93 Per Hour
Company Size	2,000 to 2,499 employees
Year Founded	2000
Website	http://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.