Experience with systems like LIMS, MES, ERP, SCADA, or DCS (e.g., Delta V) for computer systems validation engineers is desirable. * Advanced knowledge of equipment, computerized systems, facilities ...
Experience with systems like LIMS, MES, ERP, SCADA, or DCS (e.g., Delta V) for computer systems validation engineers is desirable. * Advanced knowledge of equipment, computerized systems, facilities ...
Perform CSV activities for laboratory instruments, engineering/manufacturing equipment, and enterprise applications . * Validate systems including LIMS, SAP, CMMS/calibration platforms , and other ...
Perform CSV activities for laboratory instruments, engineering/manufacturing equipment, and enterprise applications . * Validate systems including LIMS, SAP, CMMS/calibration platforms , and other ...
Experience with systems like LIMS, MES, ERP, SCADA, or DCS (e.g., Delta V) for computer systems validation engineers is desirable. * Advanced knowledge of equipment, computerized systems, facilities ...
Experience with systems like LIMS, MES, ERP, SCADA, or DCS (e.g., Delta V) for computer systems validation engineers is desirable. * Advanced knowledge of equipment, computerized systems, facilities ...
Your Role As a Qualification & Validation Engineer , you will support our clients in complex GMP ... Confident use of MS Office; familiarity with MS Project, LIMS, TrackWise, SAP, or electronic ...
Your Role As a Qualification & Validation Engineer , you will support our clients in complex GMP ... Confident use of MS Office; familiarity with MS Project, LIMS, TrackWise, SAP, or electronic ...
Validation Engineer At Nivagen as a Validation Engineer you will be responsible for ensuring that ... LIMS systems). * Aseptic processing or sterile manufacturing practices. Requirements: * Must live ...
Validation Engineer At Nivagen as a Validation Engineer you will be responsible for ensuring that ... LIMS systems). * Aseptic processing or sterile manufacturing practices. Requirements: * Must live ...
Validation Engineer At Nivagen as a Validation Engineer you will be responsible for ensuring that ... LIMS systems). * Aseptic processing or sterile manufacturing practices. Requirements: * Must live ...
Quick apply
Validation Engineer At Nivagen as a Validation Engineer you will be responsible for ensuring that ... LIMS systems). * Aseptic processing or sterile manufacturing practices. Requirements: * Must live ...
Validation Engineer At Nivagen as a Validation Engineer you will be responsible for ensuring that ... LIMS systems). * Aseptic processing or sterile manufacturing practices. Requirements: * Must live ...
Validation Engineer At Nivagen as a Validation Engineer you will be responsible for ensuring that ... LIMS systems). * Aseptic processing or sterile manufacturing practices. Requirements: * Must live ...
QMSs, ERPs, LIMS, Change/Incident Management (ServiceNow), Requirements and Testing (DevOps, JIRA ... Ability to lead validation projects and/or validation tasks/phases of larger projects (including ...
QMSs, ERPs, LIMS, Change/Incident Management (ServiceNow), Requirements and Testing (DevOps, JIRA ... Ability to lead validation projects and/or validation tasks/phases of larger projects (including ...
... engineering or equivalent work experience with 2 - 5 years validation experience in the ... MES, PLC, SCADA, LIMS, CDAS, CDMS, EDC, CTMS, SAP) Experience with Client Server, RDMS Database ...
... engineering or equivalent work experience with 2 - 5 years validation experience in the ... MES, PLC, SCADA, LIMS, CDAS, CDMS, EDC, CTMS, SAP) Experience with Client Server, RDMS Database ...
Computer System Validation (CSV) Consultants(Biotech Industry exp is must)(Only Visa Independent Can
Piscataway, NJ · On-site
Perform CSV activities for laboratory instruments, engineering/manufacturing equipment, and enterprise applications . * Validate systems including LIMS, SAP, CMMS/calibration platforms , and other ...
Computer System Validation (CSV) Consultants(Biotech Industry exp is must)(Only Visa Independent Can
Piscataway, NJ · On-site
Perform CSV activities for laboratory instruments, engineering/manufacturing equipment, and enterprise applications . * Validate systems including LIMS, SAP, CMMS/calibration platforms , and other ...
QMSs, ERPs, LIMS, Change/Incident Management (ServiceNow), Requirements and Testing (DevOps, JIRA ... Systems Validation Education: * Bachelor of Science Degree, Computer Engineering, or relevant ...
QMSs, ERPs, LIMS, Change/Incident Management (ServiceNow), Requirements and Testing (DevOps, JIRA ... Systems Validation Education: * Bachelor of Science Degree, Computer Engineering, or relevant ...
Computer Systems Validation Engineer
OR · On-site +1
$80K - $120K/yr
How This Role Makes a Difference The Computer System Validation Engineer is responsible for ... QMS, CTMS, LIMS, eSource, eBinder How We Work Together * Location : Remote within the United States.
Computer Systems Validation Engineer
OR · On-site +1
$80K - $120K/yr
How This Role Makes a Difference The Computer System Validation Engineer is responsible for ... QMS, CTMS, LIMS, eSource, eBinder How We Work Together * Location : Remote within the United States.
Computer Systems Validation Engineer
Boston, MA · Remote
$80K - $120K/yr
How This Role Makes a Difference The Computer System Validation Engineer is responsible for ... QMS, CTMS, LIMS, eSource, eBinder How We Work Together * Location : Remote within the United States.
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Computer Systems Validation Engineer
Boston, MA · Remote
$80K - $120K/yr
How This Role Makes a Difference The Computer System Validation Engineer is responsible for ... QMS, CTMS, LIMS, eSource, eBinder How We Work Together * Location : Remote within the United States.
Computer Systems Validation Engineer
$80K - $120K/yr
How This Role Makes a Difference The Computer System Validation Engineer is responsible for ... QMS, CTMS, LIMS, eSource, eBinder How We Work Together * Location : Remote within the United States.
Computer Systems Validation Engineer
$80K - $120K/yr
How This Role Makes a Difference The Computer System Validation Engineer is responsible for ... QMS, CTMS, LIMS, eSource, eBinder How We Work Together * Location : Remote within the United States.
CQV Sample Management / LIMS Coordinator
Juncos, PR · On-site
$17.75 - $24/hr
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... CQV Sample Management / LIMS Coordinator Job Summary: We are seeking an experienced CQV Sample ...
CQV Sample Management / LIMS Coordinator
Juncos, PR · On-site
$17.75 - $24/hr
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... CQV Sample Management / LIMS Coordinator Job Summary: We are seeking an experienced CQV Sample ...
CQV Sample Management / LIMS Coordinator
Juncos, PR · On-site
$17.75 - $24.25/hr
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... We are seeking an experienced CQV Sample Management / LIMS Coordinator to support cleaning ...
CQV Sample Management / LIMS Coordinator
Juncos, PR · On-site
$17.75 - $24.25/hr
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... We are seeking an experienced CQV Sample Management / LIMS Coordinator to support cleaning ...
The LabVantage LIMS Support Engineer will provide technical support, configuration, troubleshooting ... validation activities. • Assist in upgrades, patches, and release management. Qualifications
The LabVantage LIMS Support Engineer will provide technical support, configuration, troubleshooting ... validation activities. • Assist in upgrades, patches, and release management. Qualifications
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... Experience with LIMS, Kneat, Smartsheet, MAXIMO, LMS, or similar GMP systems. * Experience ...
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... Experience with LIMS, Kneat, Smartsheet, MAXIMO, LMS, or similar GMP systems. * Experience ...
Lead Engineer LIMS - LabVantage
Cincinnati, OH · Remote
$73K - $174K/yr
The Lead LIMS Engineer will partner closely with laboratory business stakeholders, quality ... Ensure all enhancements follow SDLC, CSV, change management, and validation procedures. * Conduct ...
Lead Engineer LIMS - LabVantage
Cincinnati, OH · Remote
$73K - $174K/yr
The Lead LIMS Engineer will partner closely with laboratory business stakeholders, quality ... Ensure all enhancements follow SDLC, CSV, change management, and validation procedures. * Conduct ...
$60 - $80/hr
The Computer System Validation (CSV) Specialist/Engineer will support the validation and lifecycle ... Experience with systems such as MES, SAP/ERP, DeltaV, PLC/HMI/SCADA, LIMS, EDMS, or other GxP ...
$60 - $80/hr
The Computer System Validation (CSV) Specialist/Engineer will support the validation and lifecycle ... Experience with systems such as MES, SAP/ERP, DeltaV, PLC/HMI/SCADA, LIMS, EDMS, or other GxP ...
Lims Validation Engineer information
See salary details
$22.60 - $27.64
2% of jobs
$27.64 - $32.69
6% of jobs
$32.69 - $37.74
13% of jobs
$39.32 is the 25th percentile. Wages below this are outliers.
$37.74 - $42.79
13% of jobs
$42.79 - $47.84
11% of jobs
The median wage is $50.36 / hr.
$47.84 - $52.88
12% of jobs
$52.88 - $57.93
9% of jobs
$61.82 is the 75th percentile. Wages above this are outliers.
$57.93 - $62.98
13% of jobs
$62.98 - $68.03
13% of jobs
$68.03 - $73.08
6% of jobs
$73.08 - $78.13
3% of jobs
$22
$51
$78
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Sr. Validation Engineer II
Thousand Oaks, CA • On-site
Full-time
Re-posted 21 days ago
Takeda Pharmaceuticals rating
7.3
Based on 71 frontline employees who took The Breakroom Quiz
Job description
Job Description
About the role:
This position supports the operations through the initial qualification to validation maintenance of equipment, systems, facilities, and utilities. Responsible and accountable for performing activities such as Cycle Development (CD), Design Qualification, Commissioning and Qualification, Performance Qualification (PQ) / Cleaning Validation (CV), and Validation Maintenance. Focused on right first-time execution and continuous improvement.
How you will contribute:
- Lead the execution of CD/PQ/CV/PV/RV activities.
- Act as project manager for validation deliverables ensuring new systems are implemented within predetermined timelines and financial forecasts.
- Supervise and manage contractors or consultants as needed.
- Participate in change control review board.
- Track and trend activities and report on issues such as impact to predetermined timelines and problems as needed.
- Serve as the Validation Engineering representative and technical subject matter expert (SME) on cross-functional and multi-site teams related to equipment, computerized systems, utilities, facility, and computerized systems.
- Apply advanced theory, technical principles, and expert judgment to address a broad range of problems.
- Troubleshoot and direct the resolution of Validation issues by fostering effective interdepartmental and cross-functional partnerships.
- Maintain a state of inspection readiness and act as SME in Health Authority inspections.
- Review and approval of commissioning documents, including but not limited to commissioning protocols and reports.
- Evaluate and leverage testing to qualification activities.
- Generate, execute, and manage the detailed project plans and timelines for the execution of CD/DQ/IQ/OQ/PQ/CV/Validation Maintenance, change management activities and their associated documentation.
- Support departmental and capital project validation activities.
- Provide validation key performance indicators data in a predetermined frequency.
- Owner of change control task of validation activities.
- Execute validation activities aimed at improving Right First-Time.
- Ensure new systems are implemented within predetermined timelines and financial forecasts.
- Present and provide rationale for the completed work during periodic audits and Health Authority inspections.
- Coordinate and perform tactical activities, including sample collection, coordinating with cross-functional support teams, retrieving data and results, completing documentation, as required per protocols.
- Coordinate and perform equipment and system re-qualification according to procedures and predetermined timelines.
- Foster an environment that encourages continuous learning. Maintain expertise as necessary to stay abreast of technical and industry advancements.
- Solve technical problems while maintaining required levels of safety, quality (including regulatory compliance), and production.
- Support EHS programs and own CAPA records as needed.
- Manage time effectively, prioritize tasks, set goals, and develop systems for achieving those goals.
- Accountable for behaviors as described in Takeda Standards, policies, and procedures.
- May perform other duties as assigned.
What you bring to Takeda:
- BS engineering with a minimum of 10+ years' experience in validation.
- Experience with systems like LIMS, MES, ERP, SCADA, or DCS (e.g., Delta V) for computer systems validation engineers is desirable.
- Advanced knowledge of equipment, computerized systems, facilities, and utilities in a regulated environment is required. Advanced knowledge of commissioning and qualification of equipment, computerized systems, computerized systems, facility, and utilities is required.
- A problem-solving mindset with strong technical and/or engineering knowledge, as well as strong ability to work collaboratively with interfaces to Process Engineering, Quality, Project Managers, Facilities, Automation, and other groups.
- Technical expertise to define validation approaches and execution of system validation activities in accordance with cGMP and applicable regulations, procedures, and industry guidance.
- Basic understanding of data and statistical analysis of validation test results.
- Knowledge of cGMPs or equivalent regulations, validation associated regulations, guidelines, and best practices.
- Ability to independently evaluate technical situations and propose potential solutions.
- Ability to work independently or in teams, partners, suppliers, and customers.
- Ability to communicate effectively at all levels in verbal and written form, including technical/business writing.
- Proficient in Microsoft Word and Excel, computer software.
Important Considerations:
At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:
- Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
- Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
- Work in a cold, wet environment.
- Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
- Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection
- The overall physical exertion of this position is light work.
- Able to work in controlled or clean room environments requiring special gowning.
- May be required to work or be assigned to a different shift as needed.
- Must be able to work more than 8 hours a day or 40 hours a workweek as required.
- May require availability outside regular business hours.
- Pace may be fast and job completion demands may be high.
- On-site - 80% or more time at the Thousand Oaks site.
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
#GMSGQ #ZR1 #LI-MA1
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
USA - CA - Thousand Oaks - Rancho Conejo
U.S. Base Salary Range:
$116,000.00 - $182,270.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
For information about our benefits, please click here.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Locations
USA - CA - Thousand Oaks - Rancho Conejo
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Job Exempt
Yes
What Takeda Pharmaceuticals employees say
Pay
Benefits
Hours and flexibility
Workplace
Get the full story on Breakroom
About Takeda Ventures
Sourced by ZipRecruiter
Industry
Investment clubs and venture capital companies, pharmaceutical product wholesalers and pharmaceutical and medicine manufacturing
Company size
1 - 10 Employees
Headquarters location
San Diego, CA, US