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Validation Engineer I

HireTalent

Vacaville, CA

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JOB DETAILS
SKILLS
Communication Skills, Continuous Improvement, Cost Effectiveness Analysis, Current Good Manufacturing Practice (cGMP), Equipment Validation, Laboratory Equipment, Laboratory Operations, Operational Support, Presentation/Verbal Skills, Problem Solving Skills, Quality Control, Regulations, Regulatory Compliance, Requirements Management, Strategic Planning, Writing Skills
LOCATION
Vacaville, CA
POSTED
16 days ago
Job Title: Validation Engineer I
Location: Vacaville, CA
Duration: 06 Months

Shift: M-F 8am - 4pm (including unpaid lunch 30 mins) 5x onsite

Job Summary:
  • With direct supervision, candidate is responsible for support and execution of QC laboratory equipment qualification activities while in full compliance with current cGMP regulations and Roche/Genentech corporate principals, quality policies, standards and core values.
  • Maintains company s right to operate, supply to patients, and cost effectiveness by actively participating in continuous improvement projects.
Duties:
Technical:
  • 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.
Job Requirements:
Education:
  • BS/BA degree (preferably in 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 of 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
Work Environment/Physical Demands/Safety Considerations:
  • Standard office environment

About the Company

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