Senior Cleaning Validation Engineer
Senior Cleaning Validation Engineer
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
$ 123930 - 160380
1 Vacancy
Job Description
At Gilead were creating a healthier world for all people. For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID19 and cancer working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.
Every member of Gileads team plays a critical role in the discovery and development of lifechanging scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions and were looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future you are the key driver in evolving our culture and creating an environment where every employee feels included developed and empowered to fulfil their aspirations. Join Gilead and help create possible together.
Job Description
Sr. Cleaning Validation Engineer
Job Responsibilities:
Serve as the Cleaning Validation lead of cross functional team and able to provide guidance during planning designing and development of projects.
Write and review technical documentation (cleaning cycle development reports SOPs system lifecycle documentation protocols & reports for engineering and validation testing cleaning validation master plans)
Creation execution of Cleaning Validation Protocols including identification and resolution of nonconformances/deviations.
Assist in preparation of regulatory submissions and presents validation in respective SME areas to regulatory authorities during regulatory inspections.
Manage contractors performing system qualifications ensure the quality of completed deliverables.
Report status and progress of qualification activities or projects to the Leadership team.
Knowledge & Skills:
Demonstrated knowledge of cleaning validation principles methodology and lifecycle associated practices.
Proven experience and expertise in executing cleaning studies for biological products.
Experience with cleaning validation programs in multiproduct facilities including biological products complex small molecule formulations potent and nonpotent products.
Demonstrated ability to use a riskbased approach for defining cleaning validation approach for new products.
Demonstrated knowledge of biopharmaceutical manufacturing including drug product formulation and fill/finish operations.
Experience with automated cleaning processes (CIP and parts washers) as well as manual cleaning and sanitization operations.
Experience with qualification of automated cleaning processes and oversight of cleaning cycle development activities.
Education & Experience:
A Bachelors Degree in Science Engineering or a related field with a minimum of seven (7) years of relevant experience OR Masters Degree in Science Engineering or a related field with a minimum of four (4) years of relevant experience.
Knowledge of the cleaning validation role inside of a cGMP manufacturing environment.
Experience working with the regulations and requirements for biologics or pharmaceuticals.
Knowledge of scientific and engineering principles in the biopharmaceutical industry.
Proven track record to create review and execute qualification protocols and associated validation lifecycle documentation including identification and resolution of nonconformances /deviations.
Automated equipment and system qualification experience in a cGMP environment for process and manufacturing equipment and systems.
Knowledge and experience with lifecycle approach to cleaning validation in multiproduct facility.
For additional benefits information visit:
For jobs in the United States:
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment and is dedicated to fostering an inclusive work environment comprised of diverse perspectives backgrounds and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race color religion national origin sex age sexual orientation physical or mental disabilitygenetic information or characteristic gender identity and expression veteran status or other nonjob related characteristics or other prohibited grounds specified in applicable federal state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973 the Vietnam Era Veterans Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990 applicants who require accommodation in the job application process may contact for assistance.
For more information about equal employment opportunity protections please view theKnow Your Rights poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Gilead Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.
Required Experience:
Senior IC
Employment Type
Full-Time
