Senior Software Engineer, Behavior Validation
General MotorsSalary not specified
Full Time
Senior (5 to 8 years)
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
Key technologies and capabilities for this role
Questions & Answers
Common questions about this position
What are the key responsibilities of the Sr. Validation Engineer II role?
Key responsibilities include developing validation schedules, project plans, protocols and reports for complex systems, resolving validation issues independently, leading investigations and CAPA recommendations, providing technical assessments for changes, and coordinating validation personnel.
What are the basic qualifications required for this position?
Candidates must be knowledgeable of GxP principles, have expertise in aseptic manufacturing principles including production of complex injectable formulations, contamination control, cleaning validation and isolator technology, and possess required experience with injectable products (biologics or pharmaceutical) along with in-depth understanding and application.
Is the salary or compensation specified for this role?
This information is not specified in the job description.
What is the work arrangement or location policy for this position?
This information is not specified in the job description.
What experience makes a strong candidate for this Sr. Validation Engineer II role?
Strong candidates will have injectable product experience in biologics or pharmaceuticals, expertise in aseptic manufacturing, contamination control, cleaning validation, isolator technology, and GxP principles, along with the ability to work independently on complex validation issues.
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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