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Validation engineer • indianapolis in
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The Validation Engineer I will help support the Radiopharmaceutical facility and GMP operations in Indianapolis.The Validation Engineer I will be responsible for the drafting and executing commissi...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Professional experience and strong knowledge with real time experience in IT Quality & Compliance, Computer System Validation / Software Testing / System Implementation in the Life Sciences industr...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
At Advanced Accelerator Applications, a Novartis company, we are committed to leading innovation in nuclear medicine and delivering the next generation of targeted radioligand therapy to cancer pat...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Provide application / system validation expertise for standalone, enterprise, and integrated systems in a regulated (GxP) environment.
Lead OT system qualification and validation, including Client / DCS...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
At Advanced Accelerator Applications a Novartis company we are committed to leading innovation in nuclear medicine and delivering the next generation of targeted radioligand therapy to cancer patie...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Commissioning Qualification Validation Engineer (CQV).Responsibilities for the Commissioning Qualification Validation Engineer (CQV).
Commissioning : Lead commissioning activities for new laboratory ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
Required •Minimum of 10 years’ experience as a Computer System Validation Consultant in a regulated environment (preferably Pharma) and must have played a lead role (able to work independently with...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
Job Title : Validation and Verification Engineer - AE Defense.Indianapolis, IN / Hybrid - 3 Office Days / Week)The AE Defense V&V Engineer is responsible for ensuring that Rolls-Royce has sufficient ove...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
Welcome to the forefront of innovation in cutting edge patient treatments! We are thrilled to present an incredible opportunity to join our high performing organization.
As a leader within the life ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
Commissioning Qualification Validation Engineer (CQV).Responsibilities for the Commissioning Qualification Validation Engineer (CQV).
Commissioning : Lead commissioning activities for new laboratory ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
A company is looking for a Validation Engineer to provide validation support for software systems in regulated environments.
Key Responsibilities Plans, executes, and documents validation activiti...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
At IPS, we are global leaders in developing innovative solutions for the consulting, architecture, engineering, project controls, procurement, construction management, and CQV of technically comple...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours
Job Description Job Title : Validation and Verification Engineer - AE Defense Working Pattern : Full t...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_1_day
Our client, a global leader in industrial dispensing & flow drill systems, is seeking a Senior Field Service Validation Engineer to provide site support in Auburn Hills & New Hudson, MI to K-Flow d...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
Creating Peace of Mind by Pioneering Safety and Security.Summer Intern – System Test / Validation Engineer, Hague Road Technical Center – Indianapolis, Indiana.
As an Allegion System Test / Validation E...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
We’re hiring a Validation Engineer to support Computer System Validation (CSV) and system qualification activities in a regulated pharmaceutical environment.
This role is ideal for someone with stro...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
PACIV stands for P rocess A utomation, C ontrols, I nstrumentation, and V alidation.As a global leader in industrial automation, process control solutions and instrumentation, we serve client...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Must be legally authorized to work in the United States without sponsorship • •.You will join one of our 45 offices in the US, be part of a committed team of over 1500 professionals, and work in team...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
If you are wondering what makes TRIMEDX different, it's that all of our associates share in a common purpose of serving clients, patients, communities, and each other with equal measures of care an...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
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Barry-WehmillerIndianapolis, IN USAserp_jobs.job_card.full_time
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STEM Diverse Talent SolutionsIndianapolis, Indiana, USAjob_description.job_card.variable_days_ago
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Position Overview :
The Validation Engineer I will help support the Radiopharmaceutical facility and GMP operations in Indianapolis. The Validation Engineer I will be responsible for the drafting and executing commissioning qualification and validation (CQV) documents and protocols which support the use of highly specialized facility utility analytical and process equipment. The position will utilize a wide range of engineering disciplines to support the advancement from construction to clinical development and subsequent GMP commercial operations. Additional responsibilities may include the onboarding of new technologies process development GMP operations support deviation investigation CAPA management continuous improvement projects and future facility expansion projects.
Key Responsibilities :
- Work with the project team and / or General Contractor as required to support the commissioning and validation of a 60000 sq. ft. office warehouse and GMP Radiopharmaceutical production facility
- Develop and implement the CQV strategies for the GMP spaces including but not limited to office warehouse development quality control sterility / microbiology and GMP production areas
- Work with consultant(s) as required to support the implementation and execution of the CQV program
- Support the engineering QC and Operations team as required to improve and implement new processes
- Provide validation support for day-to-day development and GMP operations
- Provide engineering and operational support as required
- Develop expertise in areas of validation (process validation QC assets CSV cleaning validation etc)
- Apply technical knowledge and abilities to investigate manufacturing deviations
- Review data and documentation to support investigations
- Participate and drive projects and continuous improvement efforts
- Draft GMP documentation including but not limited to SOPs Forms Protocols Technical Documents Reports Deviations CAPAs Change Controls and reports.
- Support Health Authority Inspections
- Maintain department KPIs related to performance
- Provide support executing equipment and process validations as necessary.
Key Skills
Python,SOC,Debugging,C / C++,FDA Regulations,Minitab,Technical Writing,GAMP,OS Kernels,Perl,cGMP,Manufacturing
Employment Type : Full Time
Experience : years
Vacancy : 1