Sr Quality Engineer I - Automation and CSV

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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