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Validation Engineer
1 day ago
Performance Validation Indianapolis, United StatesAbout Us · Here at Performance Validation, Inc (PV) we have been providing Commissioning, Qualification, and Validation services to the life science industries for 35 years We are a 100% employee owned company with teams in Indiana, Michigan, Illinois, Kansas, Washington, and Nor ...
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Validation Engineer
1 week ago
Insight Global Indianapolis, United StatesInsight Global is looking for a mechanical or electrical engineer with validation experience. Any kind of HVAC experience is a plus. Will develop documentation/blueprints/designs and sequences of operation for evaluation and validation of existing and new HVAC systems. Will devel ...
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Senior Validation Engineer
3 weeks ago
Integrated Resources Indianapolis, United StatesIntegrated Resources, Inc · Indianapolis, IN (Onsite) · Full-Time · Intent to convert after 90 days based on performance. · Pharmaceutical experience required. · Monday to Friday 8 am to 5 pm · Job Description: · How will you make an impact? · The Process Validation Engineer w ...
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Validation Project Engineer
2 weeks ago
PSC Biotech Indianapolis, United StatesJob Description · Job 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 ...
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Engineer III, Validation
1 week ago
Thermo Fisher Scientific Indianapolis, United StatesJob Description · As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and s ...
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Senior Validation Engineer
1 week ago
LanceSoft Indianapolis, United StatesHow will you make an impact?Intent to convert after 90 days based on performance. · Pharmaceutical experience required. · Monday to Friday 8am to 5pm · The Process Validation Engineer will mentor and support in the diagnoses and resolution of software, instrument, and process pro ...
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Senior Validation Engineer
2 days ago
PSC Biotech Indianapolis, United StatesJob Description · Job 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 ...
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Validation Engineering Consultant
2 days ago
Project Farma Indianapolis, United StatesThis role can involve up to 100% Travel · 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 ...
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Sr. Validation Engineer
3 weeks ago
Maxonic Indianapolis, United StatesMaxonic maintains a close and long-term relationship with our direct client. In support of their needs, we are looking for a Sr. Validation Engineer. · Job Description: · Position: Sr. Validation Engineer · Location: Indianapolis, IN · Duration: 9+ months · Work Schedule: ON ...
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Sr. Validation Engineer
4 weeks ago
Maxonic, Inc. Indianapolis, United StatesMaxonic maintains a close and long-term relationship with our direct client. In support of their needs, we are looking for a Sr. Validation Engineer. · Job Description: · Position: Sr. Validation Engineer · Location: Indianapolis, IN · Duration: 9+ months · Work Schedule: ONSITE ...
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Senior Validation Engineer
1 week ago
PACIV Indianapolis, United StatesPACIV, 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) ...
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Senior Validation Engineer
2 weeks ago
PSC Biotech Indianapolis, United StatesJob 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 ...
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Validation Engineer
3 weeks ago
The International Society for Pharmaceutical Engineering Inc Indianapolis, United StatesPosition: · Validation Engineer (Pharmaceutical) · Location: · Indianapolis, IN · Duration: · 9 Months · Job Type: · Contract · Work Type: · Onsite · Shift: · Monday to Friday - 08:00 AM to 05:00 PM · Pay Rate: · 30-35/Hourly/W2 · Overview: · TekWissen Group is a workforc ...
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Sr. Quality Engineer, Validation
1 week ago
Cardinal Health Indianapolis, United StatesAnticipated salary range: $66,500 - $95,000 · Bonus eligible: No · Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being. Medical, dental and vision coverage · Paid time off plan · Health savings account (HSA) · 401k saving ...
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Sr. Quality Engineer, Validation
2 days ago
Cardinal Health Indianapolis, United States**Anticipated salary range:** $66,500 - $95,000 · **Bonus eligible:** No · **Benefits:** Cardinal Health offers a wide variety of benefits and programs to support health and well-being. · + Medical, dental and vision coverage · + Paid time off plan · + Health savings account ...
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Sr. Process Validation Engineer
3 weeks ago
Yoh Indianapolis, United StatesYoh is hiring a Sr. Process Validation Engineer for our well-established client in Indianapolois, IN. The mission with this client is to enable our customers to make the world healthier, cleaner, and safer. They run the world's largest clinical packaging operation and the clinica ...
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Validation Engineer Senior 2
1 week ago
CAI Indianapolis, United StatesWe are seeking CQV Engineers with 8-12 years' experience and we can assist with relocation costs. · Position Description: · The CQV Engineer develops the documentation to support Commissioning, Qualifications, and Validation. These people are responsible for protocol writing an ...
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Sr. Validation Engineer
4 weeks ago
Maxonic Indianapolis, United StatesMaxonic maintains a close and long-term relationship with our direct client. In support of their needs, we are looking for a Sr. Validation Engineer. · Job Description: · Position: Sr. Validation Engineer · Location: Indianapolis, IN · Duration: 9+ months · Work Schedule: ONSITE ...
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Sr. Validation Engineer
4 weeks ago
Maxonic Indianapolis, United StatesMaxonic maintains a close and long-term relationship with our direct client. In support of their needs, we are looking for a Sr. Validation Engineer. · Job Description: · Position: Sr. Validation Engineer · Location: Indianapolis, IN · Duration: 9+ months · Work Schedule: ON ...
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Senior Validation Engineer
3 weeks ago
THINK DIFFERENT IT | PHARMA Indianapolis, United StatesAre you looking for an established company where you have continuous growth opportunities? Join a leading global Fortune 100 organization that manufactures and creates innovative solutions · We are recruiting for a direct hire · Senior Validation Engineer · position. · Compensa ...
Validation Engineer - Indianapolis, United States - Katalyst HealthCares & Life Sciences
Description
Responsibilities:
Determine project scope and strategy with client groups and other stakeholders to execute small and large capital projects in a cGMP environment.
Participate in the development of the following Validation efforts: Validation Planning, Protocol Generation, Protocol Execution, Familiar with GAMP/GMP process, and not limited to FATs/SATs, Product validation risk assessments, IOQ's, PQ's etc.
Directs project validation work to ensure the manufacture of high-quality product and to facilitate compliance with regulatory requirements.
Liaise with internal engineering project co-ordination team, consultants, subcontractors, supervisors and the general workforce involved in the project to ensure full compliance with solution requirements.
Leading and supporting SATs.
Work with cross functional teams during the commissioning and validation phases of a project, ensuring clear communication and hand-off of information.
Supporting and representing the technical quality team in meetings, visits, troubleshooting exercises, and audits
Help determine, draft, and author project cGMP documentation such as Validation Master Plans, Specific Validation Project Plans, Schedules, IQ/OQ/PQ Protocols, Final Reports, Deviations, and Investigation support.
Assist with the development of project schedules by studying project plans, system boundaries, and validation package deliverables; calculating time requirements; sequencing validation elements.
Prepare validation reports by collecting, analyzing, and summarizing information during execution.
Help oversee vendor activities to include coordination and communication to ensure project efforts progress while maintaining safety.
Performs duties in compliance with environmental, health and safety related rules, policies or governmental regulations.
Requirements:
Bachelor's degree in engineering.
8 to 15 years of experience in the in the Engineering/Manufacturing/ Scientific field with Commissioning, Qualification and Validation of Equipment (Extruders, Molds & Molding equipment, automation for manufacturing), Utilities and/or Facilities in a cGMP environment
Works without supervision and is Quality driven
GMP/cGMP change control process experience.
Validation/qualification process knowledge.
Creative thinking and problem-solving skills
Attention to detail.
Proven track record of being self-motivated and capable of working in diverse team situations with Company clients and maintaining a positive attitude towards project challenges.
Experience with supporting Supplier Validations, Supplier Changes, Supplier Management and Component Qualification; preferably experience with Injection Moulding, Metal forming, extrusion, automation for manufacturing.
