Naderi Engineering, Inc
Validation Engineer - CSV ITOT
Naderi Engineering, Inc, Hillsboro, Oregon, United States, 97104
Base pay range
$68.00/hr - $75.00/hr Location: Hillsboro, OR - onsite position Resource type: Contractor 12 months with possibility of extension Overview
This position, based in Hillsboro, Oregon, provides an opportunity to contribute to a highly automated pharmaceutical drug substance facility. The site uses integrated computer control systems to manage plant operations and manufacturing data. The ITOT team supports manufacturing operations and is undergoing a digitalization transformation to standardize and leverage new technologies. What youll be working on
Active involvement in the daily operations for all Manufacturing ITOT systems and infrastructure to support the system owners and the manufacturing site projects, along with related administrative tasks and validation activities. Responsibilities
Be responsible for the review of system documentation according to Roche CSV SOPs and regulatory guidance. Develop plans and reports such as validation plans/reports, test plans/reports (and other deliverables). Update existing validation deliverables and procedures in collaboration with the system owners. Apply ALCOA+ principles to validation deliverables and quality management system records. Support deviation investigations to identify root causes and define corrective and/or preventative actions. Support system audit/inspection preparation and execution as CSV subject matter expert. Complete or orchestrate timely completion of post-audit action items. Support system maintenance and enhancement activities, ensuring the validated state is kept, and it is audit and inspection ready. Support system periodic reviews according to company procedures. Collaborate with local and global stakeholders in defining and completing validation and compliance activities. Education
Bachelor of Science or equivalent in computer science, engineering, life sciences, or related field. Minimum 6+ years experience in IT, OT or Software Technical Writing, Quality Systems, and Validation (CSV/CSA, GAMP), preferably in a regulated industry. Good understanding of the ISA-95 model. Experience working with Level 2 and Level 3 systems is required. Experience working with Level 1 systems is a plus. Good knowledge of FDA regulations/guidance (i.e. CFR 21 Part 11, Annex 11, EU GMP Annex 1, GxP practices) and Data Integrity principles. Good understanding of system and data risk assessment concepts. Strong ownership, results orientation, and effective written and verbal communication skills. Ability to work collaboratively in cross-functional and agile teams to achieve milestones and goals. Ability to build trustful and productive relationships, think innovatively, and translate ideas into actionable plans. Ability to work with stakeholders from different technical domains and cultures. Technical skills
Knowledge of or experience with system administration and recipe authoring, industrial data and manufacturing controls systems. Familiarity with IT service management, quality and document management systems such as Veeva, HP ALM, Valgenesis, and ServiceNow. Awareness of Manufacturing IT trends: Smart Buildings, Smart Manufacturing, Industrial IoT, Cybersecurity, Data Integrity principles, data standardization. Seniority level
Mid-Senior level Employment type
Contract Job function
Consulting Industries
Pharmaceutical Manufacturing #J-18808-Ljbffr
$68.00/hr - $75.00/hr Location: Hillsboro, OR - onsite position Resource type: Contractor 12 months with possibility of extension Overview
This position, based in Hillsboro, Oregon, provides an opportunity to contribute to a highly automated pharmaceutical drug substance facility. The site uses integrated computer control systems to manage plant operations and manufacturing data. The ITOT team supports manufacturing operations and is undergoing a digitalization transformation to standardize and leverage new technologies. What youll be working on
Active involvement in the daily operations for all Manufacturing ITOT systems and infrastructure to support the system owners and the manufacturing site projects, along with related administrative tasks and validation activities. Responsibilities
Be responsible for the review of system documentation according to Roche CSV SOPs and regulatory guidance. Develop plans and reports such as validation plans/reports, test plans/reports (and other deliverables). Update existing validation deliverables and procedures in collaboration with the system owners. Apply ALCOA+ principles to validation deliverables and quality management system records. Support deviation investigations to identify root causes and define corrective and/or preventative actions. Support system audit/inspection preparation and execution as CSV subject matter expert. Complete or orchestrate timely completion of post-audit action items. Support system maintenance and enhancement activities, ensuring the validated state is kept, and it is audit and inspection ready. Support system periodic reviews according to company procedures. Collaborate with local and global stakeholders in defining and completing validation and compliance activities. Education
Bachelor of Science or equivalent in computer science, engineering, life sciences, or related field. Minimum 6+ years experience in IT, OT or Software Technical Writing, Quality Systems, and Validation (CSV/CSA, GAMP), preferably in a regulated industry. Good understanding of the ISA-95 model. Experience working with Level 2 and Level 3 systems is required. Experience working with Level 1 systems is a plus. Good knowledge of FDA regulations/guidance (i.e. CFR 21 Part 11, Annex 11, EU GMP Annex 1, GxP practices) and Data Integrity principles. Good understanding of system and data risk assessment concepts. Strong ownership, results orientation, and effective written and verbal communication skills. Ability to work collaboratively in cross-functional and agile teams to achieve milestones and goals. Ability to build trustful and productive relationships, think innovatively, and translate ideas into actionable plans. Ability to work with stakeholders from different technical domains and cultures. Technical skills
Knowledge of or experience with system administration and recipe authoring, industrial data and manufacturing controls systems. Familiarity with IT service management, quality and document management systems such as Veeva, HP ALM, Valgenesis, and ServiceNow. Awareness of Manufacturing IT trends: Smart Buildings, Smart Manufacturing, Industrial IoT, Cybersecurity, Data Integrity principles, data standardization. Seniority level
Mid-Senior level Employment type
Contract Job function
Consulting Industries
Pharmaceutical Manufacturing #J-18808-Ljbffr