- 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.
- Ensures that all deviations to protocols and/or deviations to acceptance criteria are adequately controlled, documented, and addressed by the Validation / Engineering Team
- 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.
- Basic understanding of design controls and design transfer.
- 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.
- Help develop Validation objectives by reviewing project proposals and plans, conferring with management.
- 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.
- Monitoring and maintaining the quality and compliance status of associated quality records.
- Assist with the development of project schedules by studying project plans, system boundaries, and validation package deliverables; calculating time requirements; sequencing validation elements.
- Control validation plan by reviewing documentation, protocols, procedures, and execution strategies, coordinating with vendors and team members.
- 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.
- 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.
- Experience working in a 21CFR820 and/or ISO13485 regulated industry.
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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
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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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Senior Validation Engineer
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Engineer III, Validation
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Senior Validation Engineer
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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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Sr. Validation Engineer
3 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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Validation Engineer
3 weeks 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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Validation Engineer
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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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Validation Engineer
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Validation Engineer
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Katalyst HealthCares & Life Sciences Indianapolis, United StatesResponsibilities: · 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, ...
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Validation Engineer Senior 2
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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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Lead Validation Engineer
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Validation Engineer - Indianapolis, United States - Katalyst HealthCares & Life Sciences
