Tranzeal Incorporated · 5 months ago
Validation Engineer II
Hillsboro, OR
Full-time
Onsite
Senior Level
6+ years expTranzeal Incorporated is a company involved in pharmaceutical manufacturing, and they are seeking a Validation Engineer II to support validation and compliance activities in a highly automated drug substance facility. The role involves reviewing system documentation, developing validation plans, and collaborating with stakeholders to ensure compliance with regulatory standards.
Big DataBusiness IntelligenceCloud InfrastructureInfrastructureMachine Learning
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 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
Qualification
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 Incorporated
Tranzeal is an industry leading global Business Transformation Service Provider.
201-500 employees
H1B Sponsorship
Tranzeal Incorporated has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2024 (6)
2023 (4)
2022 (6)
2021 (7)
2020 (15)
Funding
Current Stage
Growth StageLeadership Team
Neha Varma
Associate Director- Client Partner
Sheehan Khera
Client Partner
Company data provided by crunchbase