Quality Engineer - III

Company: Calsoft Labs
Location: Santa Monica
Posted on: June 13, 2022

Job Description:

Job Description

Quality Engineer III

Job Description

Kite is a cell therapy company that is focused on providing patients with highly effective, life-saving therapies. Everyone at Kite is grounded by one common goal curing cancer. Every single day, we seek to establish a direct 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 Quality Engineer III, at our location in Santa Monica. The ideal candidate will interface and build strong partnerships with other parts of the organization. This position must excel in an environment that embraces teamwork, change, risk-based decision making, and flexibility.
The candidate will be responsible for overseeing and approving laboratory equipment validation strategies required to complete assigned validation projects. An ideal candidate would have extensive experience with the performance of such validation activities that include Equipment/Utility/Facility Qualification and Cleaning Validation across the entire validation lifecycle from Plan to Retire.
This role is expected to make a significant contribution to a multi-disciplinary team driving adherence and consistent implementation of the Pharmaceutical Quality System across the network. A successful individual will be self-motivated to take actions and have excellent written, verbal communication, and critical thinking skills.

Responsibilities:

Lead and/or support risk analysis activities. Demonstrate proficiency in applying various risk management and risk mitigation tools and practices such as FMEA and others.
Create and maintain the site validation master plan and its periodic review program.
Lead/coordinate completion of Equipment Qualification deliverables such as user requirement specifications (URS), system impact assessments (SIA), Qualification Protocols (IQ/OQ/PQ), Design Specifications, Functional Risk Assessments (FRS), etc.
Ensure periodic reviews of Risk Management Reports are performed according to schedule.
Support change controls and related activities
Ensure validation and data integrity requirements are met in accordance with company procedures
Provide insight as a subject matter expert (SME) on the risks associated with analytical equipment such as chromatography, compendial analytical methods, Flow Cytometry, etc.
Provide insight as a subject matter expert (SME) on the risks associated with data integrity associated with analytical equipment.
Provide quality oversight of site Validation Engineering execution activities, and external partners
Apply Statistical methods and Data Analytical Tool for Data Analysis.
Support Equipment and laboratory life cycle processes.
Support continuous improvement initiatives and identify and implement tools/processes for continuous improvement
Communicate effectively at all levels within Quality, as well as cross functionally with departments and sites
Perform other duties in support of the quality system as assigned.

Basic Qualifications:

Masters Degree in technical discipline (Engineering/Biology/Chemistry/Microbiology) and 3+ years experience in a pharmaceutical or FDA regulated environment OR
Bachelors Degree in technical discipline (Engineering/Biology/Chemistry/Microbiology) and 5+ years experience in a pharmaceutical or FDA regulated environment OR
High School Degree in technical discipline (Engineering/Biology/Chemistry/Microbiology) and 9+ years experience in a pharmaceutical or FDA regulated environment

Preferred Qualifications:

Bachelors degree in Engineering with a strong knowledge of Quality Engineering /Scientific Method and Techniques.
Excellent technical writing experience in a regulatory environment.
Experience Equipment, Facility and Utility IQ/OQ/PQ/PV
Knowledge in computer System validation in a GMP environment
Strong Knowledge of Risk Assessments and Risk Mitigation tools (e.g. FMEA).
Strong Knowledge of Change Control Practices
Strong written and verbal communication skills
Strong Analytical and Statistical skills

Familiarity with global regulatory agencies requirements for Quality Risk Management and Quality
Systems (ICH Q9, GAMP5, 21CFR 11/210/211)
Ability to function efficiently in a diverse, fast paced, and changing environment.

Keywords: Calsoft Labs, Santa Monica , Quality Engineer - III, Engineering , Santa Monica, California