Sr. Validation Engineer II at Gilead Sciences

La Verne, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

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

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

Skills

Validation Protocols

Validation Schedules

Project Plans

CAPA

Investigations

Technical Assessment

Process Changes

Manufacturing Validation

GMP

Gilead Sciences

Develops and commercializes biopharmaceuticals

About Gilead Sciences

Gilead Sciences focuses on discovering, developing, and commercializing medicines for various medical conditions, including HIV/AIDS, liver diseases, cancer, inflammatory and respiratory diseases, and cardiovascular issues. The company conducts extensive research and development to create new therapies, which are then marketed to healthcare providers, hospitals, and pharmacies after receiving regulatory approval. Gilead differentiates itself from competitors through its strong commitment to R&D and strategic partnerships, such as with SAP Ariba, to enhance its operations and product offerings. The company's goal is to improve health equity and access to care globally, working with communities to ensure that its medicines reach those in need.

Foster City, CaliforniaHeadquarters

1987Year Founded

$15,873.6MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Paid family time off and paid parental time off

Generous 401(k) contribution matching

Comprehensive medical plans that cover both physical and mental healthcare

Global Wellbeing Reimbursement

Time Off

Global Volunteer Day

Giving Together Program

Employee Support Programs

Flexible Work Options

Risks

Increased competition in HIV treatment from ViiV Healthcare's expanding drug portfolio.

Regulatory scrutiny over drug pricing could impact Gilead's U.S. market operations.

Patent expirations, like Truvada's, lead to increased generic competition and revenue loss.

Differentiation

Gilead's lenacapavir is recognized as the 2024 Breakthrough of the Year for HIV care.

Partnerships with LEO Pharma and Tubulis enhance Gilead's focus on inflammatory and cancer therapies.

Gilead's commitment to health equity initiatives like COMPASS and HepConnect sets it apart.

Upsides

Gilead's strategic partnerships expand its reach in inflammatory and oncology drug markets.

Investment in digital health technologies enhances Gilead's R&D and patient engagement.

Focus on sustainability improves Gilead's operational efficiency and corporate reputation.

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