Katalyst CRO ยท 1 month ago
Validation Specialist
Woodside, CA
Contract
Onsite
Mid LevelKatalyst CRO is focused on ensuring compliance with GMP requirements in the digital solutions space. The Validation Specialist will be responsible for developing qualification strategies and ensuring that digital equipment meets regulatory standards while collaborating with various stakeholders.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Develop and implement a qualification strategy for digital equipment, ensuring alignment with regulatory requirements, industry best practices, and Roche's internal standards
Create qualification plans and protocols for equipment that will be connected to RCN including their interfaces and automation applications. Ensure that all qualification activities are properly documented and executed according to established procedures
Conduct risk assessments to identify potential risks associated with the use of digital solutions in a GMP environment. Develop risk mitigation strategies and ensure that appropriate controls are in place
Collaborate with cross-functional teams to perform testing and qualification activities for digital solutions, particularly with QA SMEs. This includes executing test cases, analyzing results, and documenting findings
Ensure that all qualification activities are compliant with relevant regulatory requirements, such as GMP and data integrity guidelines. Maintain accurate and up-to-date validation documentation, including validation plans, protocols, reports, and change control documentation
Drive continuous improvement initiatives related to qualification processes, tools, and methodologies. Stay updated with the latest industry trends and regulatory requirements in the field of validation
Act as an interface between business and IT functionals and as a contact point for business leads in order to launch initiatives, leading and driving the scoping phase
Qualification
Required
Understanding of lab systems lifecycle models and experience with business/end-user applications
Strong knowledge in qualification principles and practices in a GMP environment. Experience in qualification of digital solutions, including Release Management processes and controls
Experience in managing infrastructure through multiple product releases, and have passion for reliability and security. Work with management to set priorities, track operational metrics
Demonstrate knowledge of current GxP requirements and documentation standards with the ability to write validation docs
Displays skills and capabilities in the area of business partnering and/or product management. Proactively lead the validation efforts throughout the E2E process and work in a cross-functional and global team
Demonstrates ability to perform detail-oriented work with a high degree of accuracy and able to explain complex concepts with clarity and simplicity
Demonstrates ability to identify, troubleshoot and resolve issues quickly and effectively
Positive attitude and high energy with exceptional cross-group collaboration working with partner teams
Possess a combination of analytical thinking, hands-on problem-solving, and a customer-service mindset
Excellent communication skills - fluent in written and spoken English
Preferred
Knowledge of pharma and/or cell & gene therapy supply chain processes is a plus
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO 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 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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