Talent.com
Validation Specialist
Validation SpecialistKatalyst HealthCares & Life Sciences • Woodside, CA
Validation Specialist

Validation Specialist

Katalyst HealthCares & Life Sciences • Woodside, CA
[job_card.30_days_ago]
[job_preview.job_type]
  • [job_card.full_time]
[job_card.job_description]

Summary:

As Qualification Specialist in the Equipment Integration team, you are responsible for caring about the GMP requirements. The team is responsible for transferring existing Lab Equipment from Spark Network to Roche Connect Network (RCN). Including replacing the HW, OS and renewing the application including the configuration and data. Your work requires you to actively interface with equipment owners, product/project managers, and business stakeholders to design and develop the build, release, and deploy for digital solutions. Responsibilities involve ensuring that our digital solutions meet regulatory requirements and quality standards, including qualified equipment, partially connected to validated software, and processes to ensure they perform as intended and comply with regulations. Excellent communication skills and teamwork are a must.

Roles & Responsibilities:
  • Qualification Strategy: Develop and implement a qualification strategy for digital equipment, ensuring alignment with regulatory requirements, industry best practices, and Roche's internal standards.
  • Qualification Plans and Protocols: 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.
  • Risk Assessment: 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.
  • Testing and Qualification: 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.
  • Compliance and Documentation: 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.
  • Continuous Improvement: 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.
  • Communication and stakeholder management: 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.

Education & Experience:
  • 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.
  • Knowledge of pharma and/or cell & gene therapy supply chain processes is a plus.
  • Displays skills and capabilities in the area of business partnering and/or product management. Proactively lead the validation efforts throughout the EE 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.

[job_alerts.create_a_job]

Validation Specialist • Woodside, CA

[internal_linking.similar_jobs]

Director, Digital Validation Strategy

Veeva SystemsSan Francisco, CA, United States
[job_card.full_time]

A leading SaaS company is seeking a Director of Validation Management Strategy to lead market expansion in North America.The role focuses on life sciences validation, driving digital transformation...[internal_linking.show_more]

 • [job_card.promoted]

Computer Systems Validation Lead

RxCloudSan Francisco, CA, United States
[job_card.full_time]

About the job Computer Systems Validation Lead.At least 10 years of experience supporting and/or performing all aspects of computer systems validation activities including development of scalable v...[internal_linking.show_more]

 • [job_card.promoted]

Provider Performance Improvement Specialist

McKinseySan Francisco, CA, United States
[job_card.full_time]

Driving lasting impact and building long-term capabilities with our clients is not easy work.You are the kind of person who thrives in a high performance/high reward culture - doing hard things, pi...[internal_linking.show_more]

 • [job_card.promoted]

Vehicle Testing Specialist

LumicitySan Francisco, CA, United States
[job_card.full_time]

I am currently representing an autonomous vehicle company who is developing innovative technology across multiple industries.As a Vehicle Testing Specialist, you will be:.Developing test plans and ...[internal_linking.show_more]

 • [job_card.promoted]

Regulatory AI Implementation Specialist

Artos AISan Francisco, CA, United States
[job_card.full_time]

A biotechnology company in San Francisco is seeking an Implementation Specialist to translate regulatory science into AI-powered tools for drug development.The role involves deconstructing regulato...[internal_linking.show_more]

 • [job_card.promoted]

Remote Biology Specialist (PhD)

TuringSan Francisco Bay Area, United States
[filters.remote]
[job_card.full_time]

Remote contract for PhDs in Biology, Biotechnology, Biochemistry, or related fields.Work on cutting-edge projects with top AI labs while earning up to $50+/hour, fully remote, with flexible weekly ...[internal_linking.show_more]

 • [job_card.promoted]

E-Billing Specialist

Cornerstone ResearchSan Francisco, CA, United States
[job_card.full_time]

The E-Billing Specialist serves as a liaison between clients, billing teams, and vendors to ensure the seamless execution of the firm's electronic invoicing lifecycle.This individual spearheads new...[internal_linking.show_more]

 • [job_card.promoted]

Clinical Specialist

Chase MedSearch LPSan Francisco, CA, United States
[job_card.full_time]

Cardiology Clinical Specialist - Sacramento, CA (On-Site).We are seeking a driven and knowledgeable.This individual will work closely with physicians, hospital staff, and sales representatives to p...[internal_linking.show_more]

 • [job_card.promoted]

Senior Facilities Validation Engineer – Pharma (Contract)

ELIQUENT Life SciencesSan Francisco, CA, United States
[job_card.temporary]

A leading life sciences company is seeking a Sr.Facilities Validation Engineer for a 6 to 12+ month contract in San Francisco.The ideal candidate will have extensive experience in EMPQ, facilities ...[internal_linking.show_more]

 • [job_card.promoted]

Integration Specialist

EvenUpSan Francisco, CA, United States
[job_card.full_time]

EvenUp is on a mission to close the justice gap using technology and AI.We empower personal injury lawyers and victims to get the justice they deserve.Our products enable law firms to secure faster...[internal_linking.show_more]

 • [job_card.promoted]

Director - Veeva Validation Management Strategy

Veeva Systems, Inc.San Francisco, CA, United States
[job_card.permanent]

Veeva Systems is a mission‑driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster.As one of the fastest‑growing SaaS companies in hist...[internal_linking.show_more]

 • [job_card.promoted]

Senior Biotech/Pharma Process Validation Engineer

Trinity Consultants - Advent EngineeringSan Francisco, CA, United States
[job_card.full_time]

A biotechnology consulting firm located near San Francisco is seeking a Life Sciences Talent Acquisition Specialist.The ideal candidate will have at least 5 years of experience in the biotech-pharm...[internal_linking.show_more]

 • [job_card.promoted]

QA Manufacturing Specialist (Cell Therapy)

Yoh, A Day & Zimmermann CompanySouth San Francisco, California, US
[job_card.full_time]

QA Manufacturing Specialist (Cell Therapy).You will support day-to-day quality operations and ensure compliance across the manufacturing processes.This role provides hands-on QA support on the manu...[internal_linking.show_more]

 • [job_card.promoted] • [job_card.new]

Training Specialist

Nortia Staffing - Human Resources, Accounting and Administrative StaffingRedwood City, CA, United States
[job_card.full_time]

We are seeking a detail-oriented and motivated.GxP training programs within a regulated biopharmaceutical environment.This role plays a critical part in ensuring compliance, training effectiveness,...[internal_linking.show_more]

 • [job_card.promoted] • [job_card.new]

Provider Performance Improvement Specialist - Clinical Workforce Management

McKinseySan Francisco, CA, United States
[job_card.full_time]

Driving lasting impact and building long-term capabilities with our clients is not easy work.You are the kind of person who thrives in a high performance/high reward culture - doing hard things, pi...[internal_linking.show_more]

 • [job_card.promoted]

Validation Engineer - Team Lead

Cloud DestinationsSan Francisco, CA, United States
[job_card.full_time]

Get AI-powered advice on this job and more exclusive features.Cloud Destinations, headquartered in Silicon Valley, specializes in digital transformation, enterprise application development, and lar...[internal_linking.show_more]

 • [job_card.promoted]

Wireless SoC RF Bring-Up & Validation Engineer - Equity

Apple Inc.San Francisco, CA, United States
[job_card.full_time]

A leading tech company in San Francisco is looking for a Wireless SoC RF Integration and Validation Engineer.The role involves delivering RF integration solutions, ensuring wireless functionality, ...[internal_linking.show_more]

 • [job_card.promoted]

Clinical Technology Specialist

ForTec MedicalSan Francisco, CA, US
[job_card.full_time]

Our Mission is to improve patient health and healthcare by delivering innovative surgical technologies on demand.ForTec’s commitment to excellence, integrity, and positive culture defines our organ...[internal_linking.show_more]