Gilead Sciences · 2 days ago
Sr. Cleaning Validation Engineer II
La Verne, CA
Full-time
Onsite
Senior Level
$143K/yr - $185K/yr
6+ years expGilead Sciences is committed to creating a healthier world and developing life-changing therapies. The Sr. Cleaning Validation Engineer II will contribute to project completions through the development of validation schedules and protocols, resolve complex validation issues, and provide leadership for the Validation team.
BiopharmaBiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Contributes directly to the completion of projects through the development of validation schedules, project plans, master plans, validation protocols and reports for systems that may be complex in nature to support clinical and commercial manufacturing
Works independently to resolve moderately complex to complex validation issues with very limited direct supervision
Conducts and serves as a lead/coordinator of investigations and corrective and preventative action (CAPA) recommendations related to distribution and validation activities
Provides technical assessment and approval for engineering and process changes
Forecast external support requirements for continuous validation support, including implementation of new projects
Coordinates the activities of assigned validation and contract personnel, ensuring the quality of completed work
Prepares regulatory submissions and presents validations to regulatory authorities during routine internal and pre-approval inspections
Provides relevant CMC support for pre- and post-approval filings
Leads standardization and harmonization of Standard Operating Procedures, leveraging existing Gilead Quality Systems
Work with Quality to adopt an effective quality management system and achieve the quality objectives
Able to implement new technologies, programs or initiatives
Provide leadership for Validation team and ensure growth and development of staff to meet changing business needs
Qualification
Required
Knowledgeable of the principles of GxPs
Expertise in aseptic manufacturing principles, including production of complex injectable formulations, contamination control, cleaning validation and isolator technology
Injectable product experience (biologics or pharmaceutical) required
Must have in-depth understanding and application of GMP principles, concepts, practices and standards in the US and internationally
Demonstrate extensive knowledge of industry best practices and trends
Able to develop and improve complex concepts, techniques, and standards and new applications based on quality principles and theories
Able to develop solutions to complex problems, which require a high degree of ingenuity, creativity and innovation
Able to exercise judgment and independently determine and take appropriate action where precedent may not exist
Excellent verbal, written, and interpersonal communications skills are required
Demonstrate ability in managing competing priorities, creating an effective team environment
A bachelor's degree in science, engineering or a related field with a minimum of eight (8) years of relevant experience or master's degree in science, Engineering or a related field with a minimum of six (6) years of relevant experience
Benefits
Discretionary annual bonus
Discretionary stock-based long-term incentives (eligibility may vary based on role)
Paid time off
Company-sponsored medical, dental, vision, and life insurance plans
Company
Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops, manufactures and commercializes therapies for critical diseases.
10001+ employees
H1B Sponsorship
Gilead Sciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (269)
2024 (241)
2023 (222)
2022 (208)
2021 (235)
2020 (187)
Funding
Current Stage
Public CompanyTotal Funding
$4.41BKey Investors
Abingworth
2024-11-13Post Ipo Debt· $3.5M
2024-02-29Post Ipo Equity· $210M
2023-09-07Post Ipo Debt· $2B
Leadership Team
Keeley Wettan
Senior Vice President, Legal
Patrick Loerch
Senior Vice President, Clinical Data Science
Recent News
2025-12-30
BioWorld Financial Watch
2025-12-29
Company data provided by crunchbase