Veeva Developer Jobs in Oregon (NOW HIRING)

Job Summary:
Tranzeal Incorporated is a company focused on pharmaceutical manufacturing and IT solutions. The Validation Engineer II role involves reviewing system documentation, developing validation plans and reports, and ensuring compliance with regulatory standards while collaborating with various stakeholders.
Responsibilities:
• Be responsible for the review of system documentation according to the 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 in deviation investigations to identify root causes and define corrective and/or preventative actions.
• Support system maintenance and enhancement activities, ensuring the validated state is kept, and it is audit and inspection ready.
• Collaborate with local and global stakeholders in defining and completing validation and compliance activities.
Qualifications:
Required:
• 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 Food and Drug Administration regulations/guidance (i.e. CFR 21 FDA Part 11, Annex 11, EU GMP Annex 1, GxP practices) and Data Integrity principles.
• Good understanding of system and data risk assessment concepts.
• Takes responsibility, drives results, and achieves expected outcomes.
• Effective communicator with excellent verbal and written communication skills.
• Ability to work collaboratively in cross-functional and agile teams to achieve milestones and goals.
• Builds trustful and effective relationships.
• Able to think innovatively and translate ideas into actionable plans.
• Ability to work productively with stakeholders from different technical domains and cultures.
Preferred:
• Knowledge of or experience with the following technical areas is a plus: System administration, software development, networking, server administration, MES Systems administration and recipe authoring, Industrial Data and manufacturing controls systems.
• Familiarity with IT Service Management, Quality and Document Management systems such as Veeva, Client ALM, Valgenesis, and ServiceNow, is a plus.
• Keep abreast of key Manufacturing IT trends and be curious - Smart Buildings, Smart Manufacturing, Industrial IoT, Manufacturing Digital Plant Maturity, Cybersecurity, Pharma 4.0, Data Integrity principles, technology, and data standardization, etc.
Company:
Tranzeal is an industry leading global Business Transformation Service Provider. Founded in , the company is headquartered in San Jose, USA, with a team of 201-500 employees. The company is currently Growth Stage.