Cleaning Validation Engineer II
Job Location:
La Verne, CA - USA
Monthly Salary:
Posted on:
Vacancies:
Job Summary
At Gilead were creating a healthier world for all people. For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID-19 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 life-changing 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
Knowledge & Skills:
- Understanding and application of validation principles concepts practices and industry standards.
- Working knowledge of current Good Manufacturing Practices (cGMPs) and regulatory requirements.
- Familiarity with equipment utility systems facility operations and automation systems.
- Strong investigation and troubleshooting skills.
- Good verbal written and interpersonal communication skills.
- Proficient in Microsoft Office applications.
Key Responsibilities:
- Perform validation activities for equipment utilities facilities processes and/or automation systems in accordance with approved SOPs cGMPs and regulatory requirements.
- Lead and execute cleaning validation activities for a multiproduct facility including parenteral and solid dose products.
- Execute validation protocols and test plans including sample collection data recording and results documentation.
- Compile analyze and interpret validation data; prepare validation reports and recommend process improvements.
- Initiate and support investigations and troubleshooting of validation deviations or failures identifying root cause and corrective actions.
- Coordinate and execute change control activities related to validation including drafting protocols reports and data summaries.
- Maintain comprehensive and compliant validation documentation and records.
- Author and revise validation procedures protocols and technical documentation.
- Coordinate and oversee contractors and external resources to ensure timely completion of validation activities.
- Collaborate with cross-functional teams (Manufacturing Quality Engineering etc.) to support project execution.
- Provide day-to-day guidance and training to validation technicians and junior staff as needed.
- Serve as a technical resource for validation-related inquiries from internal teams contractors and vendors.
- Resolve moderately complex validation issues with limited supervision while ensuring compliance and data integrity.
- Experience with recovery studies and cleaning validation within GMP-regulated environments
- Hands-on experience with swabbing execution for cleaning verification and monitoring
- Occasionally support night weekend and off-shift schedules as needed based on business demands
Basic Qualifications:
- Bachelors degree in a science or related field with at least 4 years of relevant experience
OR
- Masters degree (MS/MBA) with at least 2 years of relevant experience.
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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 non-job related characteristics or other prohibited grounds specified in applicable federal state and local 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
Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about discussed or disclosed their own pay or the pay of another employee or applicant. However employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information unless the disclosure is (a) in response to a formal complaint or charge (b) in furtherance of an investigation proceeding hearing or action including an investigation conducted by the employer (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
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:
IC
About Company
Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensu ... View more
