- Act as a Validation Lead for multiple products (applications) for GxP compliance
- Assist building a standardized method of enabling / implementing the SOPs for the GxP applications and getting the teams to adopt the standard approach
- Manage and execute validation plans and validation documents for new systems in scope
- Analyze and propose changes to already validated systems and recommend requisite level of validation activities
- Act as project manager for validation projects process
- Responsible for overseeing other teams / individuals that are doing the actual executions (lead/coordinate/manage)
- Act as single point of contact to plan, gauge workload, and help the multiple teams streamline to standards for multiple teams responsible for the validation of their individual products
- Coordinate with business to support the required software change
- Help create system requirements and specifications to ensure requirements can be tested to meet the validation goals
- Support auditing of internal computer systems validation activities, protocol and procedures along with preparing appropriate responses
- Initiate / Prepare and closeout all validation related deviations, discrepancies and change control documents
- Support development teams in creating, and maintaining test plans, test scripts and user acceptance tests
- Manage the execution of test plans
- Guide the teams in the proper execution of validation documents
- Overall 15+ years IT experience
- 8+ years of relevant experience in computer system Validation preferably in a pharma company
- Experience and good knowledge in CSV / CSA
- Experience in managing other teams and individuals
- Knowledge of GxP
- Have good organization skills
- Ability to work on multiple projects in parallel
- Good verbal and written communication skills
- Ability to provide guidance on revising validation documents and protocols
-
Computer Systems Validation Lead
3 weeks ago
RxCloud San Francisco, United StatesAbout 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 validation strategies, documents, and perform document reviews · At least 7 year ...
-
Lead Systems Validation Engineer
6 days ago
Apple Sunnyvale, United StatesLead Systems Validation Engineer · Sunnyvale,California,United States · Hardware · Hardware Engineering is looking for a system hardware validation engineer to develop new hardware test plans, test execution and validation of hardware designed for large scale deployment and in ...
-
Lead Systems Validation Engineer
3 days ago
Apple Sunnyvale, United StatesSummary · Posted: May 14, 2024 · Weekly Hours: 40 · Role Number: · Hardware Engineering is looking for a system hardware validation engineer to develop new hardware test plans, test execution and validation of hardware designed for large scale deployment and integrated use. ...
-
Power Validation Lead Engineer
3 weeks ago
Quest Global Sunnyvale, United StatesRequired Skills (Technical Competency): · 8+ years of experience in Power consumption measurement of various device use cases done in on-site lab environment. · Debugging power regressions by analyzing electrical results and device logs. · Ability to network, build relationships ...
-
IO Sensor Validation Lead Engineer
2 days ago
QuEST Global Sunnyvale, United StatesThis individual will be responsible for smart glass sensor bring-up/ characterization/ validation. This engineer will develop test systems to enable rapid evaluation and testing of sensor sub-systems. · We are looking for someone who understand I/O Sensor functionality and how w ...
-
Product Validation Lead
1 week ago
Meta Inc Sunnyvale, United StatesSummary: · The Product Validation Team is a key team in the Wearable Product Organization that focuses on end-to-end systems validation from new product introduction, new technology introduction, factory readiness, product launch and post-launch testing. As a Product Validation L ...
-
Product Validation Lead
4 days ago
Meta Sunnyvale, United StatesThe Product Validation Team is a key team in the Wearable Product Organization that focuses on end-to-end systems validation from new product introduction, new technology introduction, factory readiness, product launch and post-launch testing. As a Product Validation Lead, you wi ...
-
Sensor Validation Lead
2 days ago
Laiba Technologies Sunnyvale, United States**Position: Sensor Validation Lead** · **Location: Sunnyvale, CA (Onsite role)** · - This individual will be responsible for smart glass sensor bring-up/ characterization/ validation. This engineer will develop test systems to enable rapid evaluation and testing of sensor sub-sys ...
-
Power Validation Lead
2 days ago
Laiba Technologies Sunnyvale, United States**Position: Power Validation Lead** · **Location: Sunnyvale, CA (Onsite role)** · - 8+ years of experience in Power consumption measurement of various device use cases done in on-site lab environment. · - Debugging power regressions by analyzing electrical results and device logs ...
-
Product Validation Lead
1 month ago
Facebook Sunnyvale, United StatesThe Product Validation Team is a key team in the Wearable Product Organization that focuses on end-to-end systems validation from new product introduction, new technology introduction, factory readiness, product launch and post-launch testing. As a Product Validation Lead, you wi ...
-
Power Validation Lead
19 hours ago
Sapear Inc Sunnyvale, United States8+ years of experience in Power consumption measurement of various device use cases done in on-site lab environment. · - Debugging power regressions by analyzing electrical results and device logs. · - Ability to network, build relationships and drive effective decision-making ac ...
-
Power Validation Lead
19 hours ago
Bluefish technologies Sunnyvale, United States8+ years of experience in Power consumption measurement of various device use cases done in on-site lab environment. · - Debugging power regressions by analyzing electrical results and device logs. · - Ability to network, build relationships and drive effective decision-making ac ...
-
Senior Staff Hardware Validation Lead
2 days ago
Aurora Innovation Mountain View, United StatesWho We Are · Aurora (Nasdaq: AUR) is delivering the benefits of self-driving technology safely, quickly, and broadly to make transportation safer, increasingly accessible, and more reliable and efficient than ever before. The Aurora Driver is a self-driving system designed to op ...
-
IO Sensor Validation Lead Engineer
3 weeks ago
QuEST Global Sunnyvale, United StatesThis individual will be responsible for smart glass sensor bring-up/ characterization/ validation. This engineer will develop test systems to enable rapid evaluation and testing of sensor sub-systems. · Roles & Responsibilities: · Characterize and validate touch, proximity senso ...
-
IO Sensor Validation Lead Engineer
3 weeks ago
Quest Global Services Sunnyvale, United StatesThis individual will be responsible for smart glass sensor bring-up/ characterization/ validation. This engineer will develop test systems to enable rapid evaluation and testing of sensor sub-systems. · We are looking for someone who understand I/O Sensor functionality and how we ...
-
AHD House Supervisor
4 weeks ago
Alameda Health System Alameda Pt, United StatesSummary · SUMMARY: The AHD House Supervisor is responsible for providing clinical oversight and direction to the nursing staff during non-business hours. The AHD House Supervisor is skilled in problem solving and crisis intervention and serves as the first level contact for Admi ...
-
AHD Charge Nurse
4 weeks ago
Alameda Health System Alameda Pt, United StatesSummary · SUMMARY: Under general supervision, the AH Charge Nurse will act as lead person for nursing or nursing support personnel and to be responsible for the operation of an assigned area for each shift and ensure optimal patient care; plans, implements, and evaluates patient ...
-
Electrical Engineer
1 week ago
SoloPoint Solutions Oakland, United States DirectQualifications:Bachelor's Degree in Electrical Engineering or related field · 5+ years of industry experience in schematics and control panel design for industrial machinery, process equipment, or capital equipment · Must have AutoCAD experience · Previous experience designing an ...
-
Director of Engineering
2 weeks ago
SirenOpt Oakland, United StatesJob Description: · SirenOpt makes a real-time micro- and nano-materials metrology sensor that is enabled by cold atmospheric plasmas. The sensor is compact, can be integrated within existing manufacturing lines, and can collect multiple material property measurements (such as thi ...
-
Kaiser Permanente Oakland, United States Full timeJob Summary: · In addition to the responsibilities listed below, this position is also responsible for overseeing all phases of data management, quality control, and reporting; programming in analytical programming languages (may include SAS, SQL, SPSS, R, Python, etc.); taking ...
GxP Validation Lead - Alameda, United States - IT Solutions LLC
Description
Role: GxP Validation Lead
Location: Onsite at Alameda, CA (2-3 Days)
The Validation Lead will be the primary liaison between product and quality teams to help validate number of products. The role will leverage strategic mindset to transform and adopt a risk-based approach to move the client towards Software Assurance.
In this role you will
Skills and Qualifications
