Senior Validation Engineer
1 week ago
PACIV, a global leader in industrial automation solutions with offices in Puerto Rico, United States, and Ireland, and servicing the Life Sciences, F&B and Utilities industries is looking for a full-time employed Senior Validation Engineer based at our USA office (Indianapolis) Job Description : The Senior Validation Engineer will be responsible for the preparation, review, and approval of quality and validation related documentation and ensuring compliance during manufacturing operations. This includes full execution of the System Development Lifecycle (SDLC) for an array of equipment and systems supporting manufacturing, laboratories and/or packaging processes. Specific assignments will vary based on the experience and expertise of the successful candidate, and the requirements and expectations of the client. Position Requirements Bachelor’s degree in Engineering or Technical discipline Minimum of eight (8) years Commissioning, Qualification, and/or Validation experience within technical/regulated industries Experience and in-depth understanding of all system lifecycle deliverables from Commissioning & Qualification (C&Q) and Computer System Validation (CSV) documents through System Retirement. This includes deliverables such as Planning (Project Validation Plan or Validation Master Plan), User/Functional Requirements, Design Specifications, Design Qualification (DQ), Commissioning (FAT, SAT, Startup), Qualification Test Protocols (IQ/OQ/PQ), Process Validation (PV), Final Reporting, and support documentation (i.e. Traceability Matrices, SOP development, PMs, calibration, etc.) Experience with standard industry Processes, Packaging, Facilities/Utilities, which may include: Control Box equipment (e.g. PLCs, HMIs, ladder logic, etc.), Packaging Labelers/Cartoners, BMS/CMS Systems (e.g. AHUs, Metasys, NAE controllers, etc.), Lab Equipment (e.g. Homogenizers, Spectrophotometers, Balances, Freezers/Coolers, etc.) and Automated in-process Filling, Assembly, and Delivery lines. Knowledge and experience with electronic document retention systems for approval, change control, and archiving purposes (i.e. Regulus, SharePoint, The Box, etc.) Knowledge of industry CSV and C&Q expectations and requirements (e.g. FDA guidelines, USP, GAMP 5, ISO, etc.) Actively participate among cross-functional teams and lead project initiatives to ensure projects are delivered on time and to required quality standards Ability to lead, manage, and execute large product launches/release, small capital projects, and process improvement changes related to the manufacturing systems within the site Desired Hard Skill Sets : Comprehensive understanding of supporting process control systems-related documentation (e.g. P&IDs, electrical drawings, certificates of conformance, etc.) CSV experience, specifically around CFR Part 11 Electronic Record and Signatures Experience with Data Historian, Migration, and Historian systems (i.e. OSI PI) Project Management experience with the ability to lead and drive projects to completion autonomously Desired Soft Skills: Comfortable with a 24/7 manufacturing environment Works well with others, within a team and takes accountability Can handle a high-pressure, high-stress work environment Result-driven and self-motivated Strong interpersonal and communication skills (verbal and presentation) Organized, with strong computer literacy such as MS Project, Excel, etc. Other Requirements Location: Indianapolis, IN Travel: Up to 10% of the time to various suppliers, collaborators, and OEM sites outside of Indianapolis Compensation Competitive Salary and Benefits Package (Medical, Dental, Vision, and Life Insurance, 401K Plan, Holidays, Vacation, Sick Time pay. Powered by JazzHR
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Senior Validation Engineer
4 months ago
Indianapolis, United States Disability Solutions Full timeSenior Validation Engineer at Precision Medicine Group (View all jobs) Indianapolis, Indiana, United States Why Precision for Medicine? 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 science industry, we are...
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Senior Validation Engineer
3 weeks ago
Indianapolis, Indiana, United States Precision Medicine Group Full timePrecision Medicine Group: Validation Engineer OpportunityWe are seeking a highly skilled Validation Engineer to join our team at Precision Medicine Group.The ideal candidate will have a strong background in validation engineering and a passion for delivering high-quality work in a fast-paced environment.Key responsibilities will include:Collaborating with...
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Senior Validation Expert
1 week ago
Indianapolis, Indiana, United States PACIV Full timeJob OverviewPACIV, a leading provider of industrial automation solutions, is seeking a full-time Senior Validation Engineer to join our team at our Indianapolis office. The ideal candidate will have a strong background in validation and commissioning, with a proven track record of ensuring compliance during manufacturing operations.The successful candidate...
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Indianapolis, United States Enterprise Unified Solutions , Inc. Full timeEnterprise Unified Solutions, Inc. (eUS) is hiring a Senior IT Engineer. We are looking for a leader to become our Senior IT Engineer. As part of a consulting team, the Senior IT Engineer provides Chief Information Officers (CIO) / Chief Technology Officers (CTO) leadership consulting and will be responsible for: strategically planning engineering...
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Senior IT Engineer
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Indianapolis, United States ZipRecruiter Full timeJob DescriptionJob Description Enterprise Unified Solutions, Inc. (eUS) is hiring a Senior IT Engineer. We are looking for a leader to become our Senior IT Engineer. As part of a consulting team, the Senior IT Engineer provides Chief Information Officers (CIO) / Chief Technology Officers (CTO) leadership consulting and will be responsible for:...
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Indianapolis, United States SAIC Full timeDescription Are you interested in joining SAIC to be part of our partnership providing high quality engineering & advisory services, system planning, integration, and architecture to our government military customers? Then consider joining the SAIC Indianapolis team as we aid our customer in collaborating, integrating, and standardizing the engineering...
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Indianapolis, United States SAIC Full timeDescription Are you interested in joining SAIC to be part of our partnership providing high quality engineering & advisory services, system planning, integration, and architecture to our government military customers? Then consider joining the SAIC Indianapolis team as we aid our customer in collaborating, integrating, and standardizing the engineering...
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4 months ago
Indianapolis, United States Enscicon Corporation Full timeOur client is seeking a highly qualified, experienced Senior Process Engineer at their Indianapolis, IN location to support their work in creating sustainable manufacturing processes for a better future.Position Overview:Lead and manage engineering projects related to process design and improvement.Develop and enhance manufacturing workflows for greater...
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Indianapolis, United States CPS Full timeOur client is a global leader in their manufacturing sector. They are looking for a Senior Process Engineer to join their team at their facility outside of Indianapolis, IN. The ideal candidate will have a mix of hands-on process, production, and project experience in a food or chemical manufacturing setting. Process Engineer/Senior Process...
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4 weeks ago
Indianapolis, United States PACIV Full timeAs a Principal Validation Engineer - CSV Program Lead, you’ll drive transformative compliance and validation projects, establishing technical vision and strategy to enhance efficiency, regulatory compliance, and operational excellence. This role offers a unique opportunity to collaborate with industry leaders, shaping advanced validation solutions within...
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Indianapolis, 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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Indianapolis, Indiana, United States Quest Global Full timeJob OverviewWe are seeking a highly skilled Senior Drafting Engineer to join our team at Quest Global. As a Senior Drafting Engineer, you will be responsible for drafting and modeling activities in UGNX and Teamcenter.
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Indianapolis, United States Belcan Corporation Full timeSenior Model-Based Systems Engineer Job Number: 352125 Category: -Software & Systems SBU Description: A Senior Model-Based Systems Engineering (MBSE) position in Indianapolis, IN is currently available at Belcan. As a Senior Model-Based Systems Engineer, you will deliver new capabilities to meet our customers' growing MBSE needs across the Digital...
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Senior Automation Engineer
4 weeks ago
Indianapolis, United States PACIV Full timePACIV, an international control systems integration, and regulatory compliance engineering firm, servicing Bio-Pharmaceutical, Medical Device, F&B, and Utility clients, is looking for a regular employee-based Senior Automation Engineer team member to join our team based in the USA office (Indianapolis) Job Description: The Sr. Automation Engineer will be...