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Sr Quality Engineer I - Automation and CSV

United States - Maryland - FrederickQualityRegular

Job Description

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve 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 world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead’s 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 we’re 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

Everyone at Kite is grounded by one common goal – curing cancer. Every single day, we seek to establish a line between that purpose and our day-to-day work. Join us in our mission!

We are seeking a highly motivated individual to join us as a Sr Quality Engineer I, reporting to the Associate Director, Quality Engineering in our state-of-the-art Frederick, MD facility.

Responsibilities:

  • Provide Quality Engineering oversight for Commissioning, Qualification, and Validation (CQV) related activities.
  • Represent site in global matrix team towards strategic CQV alignment, and corporate CQV goals.
  • Site Quality Engineering SME for local CQV deliverables.
  • Provide guidance to the QE CQV team and cross-functional system owners.
  • Support the change control process for validated systems.
  • Support the site validation team.
  • Support the cross-functional system owners with strategic quality oversite and input with CQV deliverables.
  • Encourage compliance aspects of CQV with Kite’s corporate Quality Engineering.
  • Support regulatory inspections and audits.
  • Support vendor qualification and – compliance audits.
  • Track, review, and report metric information for use in continuous improvement of areas of responsibility.
  • Supports efforts/teams focused on identifying primary root causes, and implements corrective and preventative actions to ensure minimal errors/issues.
  • Guides and demonstrates compliance with agency regulations/guidance and standard operating procedures regarding new system implementation, CQV planning and deliverables, and risk management.
  • Authors technical investigation reports, including root causes as they relate to equipment, instruments, and/or facilities-related tasks.
  • Actively collaborates with external service providers and internal stakeholders to ensure compliance with regulations.
  • Uses advanced statistical techniques for data analysis. Uses complex research techniques and methodologies such as Six Sigma and Kaizen to improve QE processes and procedures.
  • Proactively recommends and implements improvements to CQV processes, and related document templates.
  • Quality Assurance, GMPs, global Health Authority Regulations, and Validation practices/principles.
  • Experience with internal and external audit principles.
  • Support other QE functions as necessary.
  • Additional duties as assigned.
  • These duties can be delegated to designated deputies of a satisfactory qualification level as needed

Basic Qualifications:

  • Master’s and 4+ years of Quality Engineering experience OR
  • Bachelor’s and 6+ years of Quality Engineering experience OR
  • Associate and 8+ years of Quality Engineering experience OR
  • High School Diploma/GED and 10+ years of Quality Engineering experience

Preferred Qualifications:

  • BA or BS in a technical discipline (Computer Science/Engineering or similar) with 6+ years or MS in a technical discipline (Computer Science/Engineering or similar) with 4+ years of experience in a GMP environment
  • 8 years of process automation and/or Computer System Validation experience in a GMP environment (Drug Substance or Drug Product).
  • Working knowledge of Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software, and various computerized systems
  • Working knowledge of regulatory requirements (21 CRF Part 11/210/211, ICH Q8, ICH Q9, ICH Q10).
  • Demonstrates in-depth knowledge of QE principles, concepts, industry practices, and standards.
  • Demonstrated experience and expertise in GAMP5 and 21 CFR Part 11 to ensuring site compliance.
  • Demonstrates excellent verbal, written, and interpersonal communication skills.
  • Demonstrates ability to interact with senior management.
  • Proficiency in concept, deployment, and support of computerized systems.
  • Proficiency in process automation across the commercialization of pharmaceutical/biotech products.
  • Meaningful knowledge of cGMP, GAMP, and quality systems.
  • Demonstrates knowledge of ICH Q9 and Risk Management resources (e.g., Hazard Analysis and Critical Control Points (HACCP) and / or Failure Mode Effects Analysis (FMEA)).
  • Certification by ASQ (Certified Six Sigma Black Belt, Certified Quality Engineer, and Certified Quality Manager) or other industry recognized professional organizations.
  • Experience with electronic validation software (e.g., Valgenesis, HPALM, KNEAT, etc.), and Manufacturing Execution Systems (e.g., Korber Pas-X, SAP MES, Emerson Syncade, etc.) is a plus.

Does this sound like you? If so, apply today!

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The salary range for this position is: $121,125.00 - $156,750.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.


For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.


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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic 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 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 ApplicantAccommodations@gilead.com for assistance.

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