Description:Job DescriptionWe are seeking a highly motivated individual to join us as Quality Engineer II, at our El Segundo location.
This position must excel in an environment that embraces teamwork, change, risk-based decision making and flexibility.
This role is expected to make a significant contribution to a multi-discipline team, must be self-motivated to take actions, and have excellent written and verbal communication skills.Job responsibilities include QE oversight of site processes related to cGMP such as Commissioning, Qualification and Validation (CQV), Computer System Configuration Management and Computer System Validation (CSV).
The position will ensure compliance with Kites corporate procedures and all applicable regulatory guidelines as well as Quality oversight of commissioning and qualification of Kites manufacturing site, providing guidance and support to the site validation group tasked with implementation of new equipment and manufacturing suites.
Responsibilities:1.Reviews commissioning, qualification, and validation testing on utilities and manufacturing process equipment and instruments under direct or indirect supervision.2.Reviews equipment specifications, manuals, and develops an understanding of how equipment works; tests equipment accurately to meet requirements for intended use.3.Reviews engineering drawings for accuracy and error corrections.4.Reviews executed protocols, final summary of commissioning and qualification reports5.Interacts with project team to identify CQV needs and work toward solutions that meet schedule, cost, and quality expectations and requirements based on Good Engineering Practices under direct or indirect supervision.
6.Quality oversight of site CQV in collaboration with Validation, Engineering and external partners ensuring compliance with company procedures, regulatory guidelines and safety standards7.Reviews the Investigation of Commissioning/Qualification failures reports.8.Ensure process control and validation requirements in accordance with company procedures.9.Apply Statistical methods and process excellence tools to evaluate qualification data.
10.Communicate effectively at all levels within Quality, as well as cross functionally with departments11.Perform other duties as assigned.Qualifications (but not limited to)1.Bachelors degree in technical discipline (Biology/Chemistry/Microbiology/Engineering or related field) with a strong knowledge of Quality Engineering /Scientific Method and Techniques.2.Minimum 5 years of experience in a pharmaceutical or FDA regulated environment.3.Knowledge of Quality Systems and pharmaceutical regulatory requirements (ICH8, ICH Q9, ICH10 GAMP5, 21CFR 11/210/211) 4.Clear understanding of cGMPs and pharmaceutical and biopharmaceutical unit operations5.Understands and can apply principles of commissioning and qualification when providing quality review.6.Able to provide critical review of DQ, FAT, SAT, OQ, PQ, and PV documents, SOPs.7.Basic understanding of working in a construction environment and possess basic understanding and knowledge to apply current industry guidelines, standards and safety requirements.8.Ability to read and interpret P& IDs and identify boundaries.9.Proficient with Microsoft Word, Excel, PowerPoint, Visio and Project10.Possesses validation knowledge in the following areas: manufacturing and utility systems, qualification of controlled temperature environments, process validation, cleaning validation, equipment qualification, and use of various temperature and relative humidity loggers11.Detail oriented.
Completes work tasks and documentation with minimal errors.12.Ability to work independently or on a team13.Strong written and verbal communication skills14.Strong Analytical and Statistical skills15.Ability to function efficiently in a diverse, fast paced, changing environment.Skills:CQV, Commissioning Validation, Commissioning, CSV, Commissioning software validation, IQ/OQ/PQ, FAT, SAT, OQ, PQ, Pharmaceutical, GMPTop Skills Details:CQV, Commissioning Validation, Commissioning, CSV, Commissioning software validation ,IQ/OQ/PQ,FAT,SAT,OQ,PQ, Pharmaceutical, GMPAdditional Skills & Qualifications:Job DescriptionWe are seeking a highly motivated individual to join us as Quality Engineer II, at our El Segundo location.
This position must excel in an environment that embraces teamwork, change, risk-based decision making and flexibility.
This role is expected to make a significant contribution to a multi-discipline team, must be self-motivated to take actions, and have excellent written and verbal communication skills.Job responsibilities include QE oversight of site processes related to cGMP such as Commissioning, Qualification and Validation (CQV), Computer System Configuration Management and Computer System Validation (CSV).
The position will ensure compliance with Kites corporate procedures and all applicable regulatory guidelines as well as Quality oversight of commissioning and qualification of Kites manufacturing site, providing guidance and support to the site validation group tasked with implementation of new equipment and manufacturing suites.
Responsibilities:1.Reviews commissioning, qualification, and validation testing on utilities and manufacturing process equipment and instruments under direct or indirect supervision.2.Reviews equipment specifications, manuals, and develops an understanding of how equipment works; tests equipment accurately to meet requirements for intended use.3.Reviews engineering drawings for accuracy and error corrections.4.Reviews executed protocols, final summary of commissioning and qualification reports5.Interacts with project team to identify CQV needs and work toward solutions that meet schedule, cost, and quality expectations and requirements based on Good Engineering Practices under direct or indirect supervision.
6.Quality oversight of site CQV in collaboration with Validation, Engineering and external partners ensuring compliance with company procedures, regulatory guidelines and safety standards7.Reviews the Investigation of Commissioning/Qualification failures reports.8.Ensure process controlExperience Level:Expert Level About Actalent:Actalent connects passion with purpose.
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