Validation Engineer
3 weeks ago
- Write and Develop Equipment/Facility/Utility and Instrument Qualification protocols (first in kind) and Validation/Qualification Policies.
- Initiate an own Change Controls; provide validation assessments and remediation plans as required by the system/equipment/components.
- Develop Commissioning and Qualification Plans.
- Develop URS, FS, DQ documents and qualification protocols (IQ/OQ/PQ) to ensure compliance with 21CFR Part 210 and 211 and adherence to ICH Q7.
- Participate in Risk-Based evaluations, utilize Risk Assessment Methods/tools, and provide technical input during FMEA processes.
- Lead discussions and provide guidance to personnel during risk assessments.
- ssure adherence to Q9 "Quality Risk Management".
- ssure Compliance with FDA and EU Regulations.
- Evaluate, document, and develop investigations attributed to qualifications failures.
- uthor Summary Reports, events, and applicable protocol amendments.
- Execute and/or provide support during protocol executions.
- ssure all the qualification items are tracked and successfully completed.
- Perform GAP analysis and provide recommendations for existing qualifications.
- bility to work in a fast pace, team-oriented environment.
- Technical problem-solving ability, manage multiple priorities, provide logical and analytical reasoning, technical writing ability, and self-training.
- Potential to manage engineering projects from design through qualification, depending on candidates experience and skill set.
- Candidate must adapt the work schedules to perform required qualification activities. This may require overnight and/or weekends.
- Complies with all company policies and standards
- Performs other functions as required or assigned
- BS or MS Degree in related Engineering field.
- t Least 4 Years of experience in automated systems, project management is a plus.
- t least 2 years' experience commissioning, validation and qualification of Equipment/Facilities/Utilities and Processes using Risk Based approach and leverage strategies.
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Validation Engineer
5 days ago
Chicago, Illinois, United States AbbVie Full timeCompany DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our...
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Validation Engineer
4 days ago
Chicago, United States PSC Biotech Full timeJob DescriptionJob DescriptionPSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements....
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Validation Engineer
4 days ago
Chicago, United States PSC Biotech Full timeJob Description Job Description PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. Our goal is to skyrocket our clients’ success, and you can be a part of our team’s...
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Lead Product Validation Engineer
1 week ago
Chicago, United States Jabil Circuit, Inc. Full timeJob Description As a Lead, you own project validation will be able to technically lead the entire cross functional design team on their interactions and responsibilities for that project. A Lead Engineer is responsible for ensuring the phase gate technical milestones are met, is the leader of technical reviews, and is responsible for making sure that the...
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PHARMACEUTICAL - Lead CQV / Validation Engineer
4 weeks ago
Chicago, United States MMR Consulting Inc Full timeJob Description Job Description Salary: Previous Pharmaceutical/Biotech experience is mandatory for this role. MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical, and biotechnology industries in North America and globally. Its services include Engineering, Project Management, Validation and other Consulting services....
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PHARMACEUTICAL - Lead CQV / Validation Engineer
4 weeks ago
Chicago, United States MMR Consulting Full timeJob DescriptionJob DescriptionSalary: Previous Pharmaceutical/Biotech experience is mandatory for this role.MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical, and biotechnology industries in North America and globally. Its services include Engineering, Project Management, Validation and other Consulting services. MMR’s...
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Validation Engineer
1 month ago
Chicago, United States Colsh Consultants LLC. Full timeStrongExperience in Computer Systems Validation (CSV) within the Pharmaceuticalindustry. • Required Bachelor's degree in pharmaceutical Science OR related field of study. •Schedule and plan equipment and process qualification workload to meet approvedschedules. •Handle multiple projects and be able to work independently as required. •Develop GxP...
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Validation Engineer IV
1 month ago
North Chicago, United States Katalyst Healthcares and Life Sciences Full timeResponsibilities: Maintaining the integrity of the client Quality System ct as a single point-of-contact to interface with Client division customers Develop and manage documentation for engineering studies ( "ES"). Execute ES activities. Develop and manage documentation for commissioning tests ( "CT"). Execute CT activities as required. Develop...
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Validation Engineer
5 days ago
North Chicago, United States Sterling Engineering Full timeJob Description Job Description Job Overview : The Validation Engineer will be responsible for the commissioning, validation, and qualification of equipment, facilities, and utilities within a pharmaceutical manufacturing environment. This role will be Temperature Mapping and updating old documentation to new standards for compliance purposes....
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Validation Engineer
4 days ago
North Chicago, United States Sterling Engineering Inc. Full timeJob DescriptionJob DescriptionJob Overview:The Validation Engineer will be responsible for the commissioning, validation, and qualification of equipment, facilities, and utilities within a pharmaceutical manufacturing environment. This role will be Temperature Mapping and updating old documentation to new standards for compliance purposes....
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Validation Engineer
5 days ago
Chicago, United States PSC Biotech Corporation Full timeJob Description PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements....
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Chicago, United States Jabil Circuit, Inc. Full timeSummary Functional AE, SME is a complement of CTO team to assist with building technology roadmap, defining executable requirements as well as responsible for feasibility study, technology investigation and PoCs. Job Overview Work with the Jabil Design Services Advanced Engineering team to define, refine and design the high-level requirements for next...
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Electronics Practical Engineer/ Engineer
4 weeks ago
Chicago, United States Alma Lasers Full timeElectronics Practical Engineer/ Engineer About The Position Electronics engineer/Practical engineer for process and technical writing for the engineering department Interesting and challenging position in the field of test equipment development work in the laboratory, NPI, and transfer from development to production Design, manufacture, and assembly of test...
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QA Engineer
4 days ago
Chicago, United States West Pharmaceutical Services, Inc Full timePress Tab to Move to Skip to Content Link Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of...
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Hardware Validation Engineer I
2 weeks ago
Chicago, United States CNA Full timeYou have a clear vision of where your career can go. And we have the leadership to help you get there. At CNA, we strive to create a culture in which people know they matter and are part of something important, ensuring the abilities of all employees are used to their fullest potential. CNA seeks to offer a comprehensive and competitive benefits package to...
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Senior Mechanical Design Engineer
6 days ago
Chicago, United States SEGULA Technologies Full timeCompany Description MUST be authorized to work in the United States for any employer. Unable to consider CPT or OPT candidates. SEGULA TECHNOLOGIES is assisting our client in hiring a Senior Mechanical Design Engineer, Chassis to join their growing team in in the West / Southwest region of the United States. Our client is an automotive / transportation...
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Manufacturing Engineer
5 days ago
Chicago, United States Vastek, Inc. Full timeJob DescriptionJob DescriptionResponsibilities•You will have the responsibility to support and continuously improve current manufacturing processes, through technical and process innovation for the manufacturing of neurovascular medical devices that save patient lives•Create and execute test protocols to qualify and validate manufacturing processes;...
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Senior Mechanical Design Engineer
1 week ago
Chicago, United States SEGULA Technologies Full timeCompany Description MUST be authorized to work in the United States for any employer. Unable to consider CPT or OPT candidates. SEGULA TECHNOLOGIES is assisting our client in hiring a Senior Mechanical Design Engineer, Chassis to join their growing team in in the West / Southwest region of the United States. Our client is an automotive / transportation...
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Project Engineer
4 weeks ago
Chicago, United States Channel Personnel Services Full timeJob DescriptionJob DescriptionØ Planning, organizing, and executing project front end loading and project design engineering including option selection, scope development, change control, cost estimating, cost control, and scheduling development and compliance for all assigned projects.Ø Providing technical support during construction and commissioning /...
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Project Engineer
4 weeks ago
Chicago, United States Channel Personnel Services Full timeJob DescriptionJob DescriptionØ Planning, organizing, and executing project front end loading and project design engineering including option selection, scope development, change control, cost estimating, cost control, and scheduling development and compliance for all assigned projects.Ø Providing technical support during construction and commissioning /...