Validation Engineer I

Job Summary With direct supervision, the candidate is responsible for supporting and executing 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 company’s right to operate, supply to patients, and cost effectiveness by actively participating in continuous improvement projects. Duties 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 authorized and described by Genentech policies, procedures and job descriptions. Perform any other tasks requested by Senior Management to support QC laboratory operations. Education & Job Requirements BS/BA degree (preferably in relevant scientific discipline) Experience (may vary depending on site size/scope) Experience in the pharmaceutical or biopharmaceutical industry or an equivalent combination of education and experience. Knowledge of cGMP or equivalent regulations. A minimum of two years’ experience in Validation or equipment qualification is desired. Ability to make sound decisions regarding scheduling and managing priorities. Flexibility in problem solving, providing direction and work hours to meet business objectives. Knowledge / Skills / Competencies Strong verbal and written communication skills and ability to influence at all levels. Capable of building trustful and effective relationships. Ability 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. #J-18808-Ljbffr Lenmar Consulting Inc