CQV Lead
Indianapolis, IN · On-site
... managing schedules, supporting FATs, overseeing qualification execution, and ensuring successful ... Validation, Quality, and Operational Readiness teams throughout the project lifecycle. Key ...
CQV Lead
Indianapolis, IN · On-site
... managing schedules, supporting FATs, overseeing qualification execution, and ensuring successful ... Validation, Quality, and Operational Readiness teams throughout the project lifecycle. Key ...
As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ... The Sterility Assurance Validation Associate I is responsible for the management and the execution ...
As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ... The Sterility Assurance Validation Associate I is responsible for the management and the execution ...
As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ... The Sterility Assurance Validation Associate I is responsible for the management and the execution ...
As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ... The Sterility Assurance Validation Associate I is responsible for the management and the execution ...
6278 - Automation Project Manager / Project Manager
Mount Vernon, IN · On-site
$86K - $113K/yr
The Automation Project Manager is responsible for leading automation and IT-focused lifecycle ... Coordinate cross-functional teams including Automation, IT, Engineering, Quality, Validation, and ...
6278 - Automation Project Manager / Project Manager
Mount Vernon, IN · On-site
$86K - $113K/yr
The Automation Project Manager is responsible for leading automation and IT-focused lifecycle ... Coordinate cross-functional teams including Automation, IT, Engineering, Quality, Validation, and ...
Engineering Project Manager
$110K - $160K/hr
Coordinate activities across Engineering, Manufacturing, Quality, Validation, Facilities, EHS, and other stakeholders. * Manage external vendors, engineering firms, contractors, and equipment ...
New
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Engineering Project Manager
$110K - $160K/hr
Coordinate activities across Engineering, Manufacturing, Quality, Validation, Facilities, EHS, and other stakeholders. * Manage external vendors, engineering firms, contractors, and equipment ...
New
... QA Manager, and works closely with manufacturing, production engineering, and supply chain teams. • Good documentation practice skills. • Good verbal and oral communication skills • Good ...
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... QA Manager, and works closely with manufacturing, production engineering, and supply chain teams. • Good documentation practice skills. • Good verbal and oral communication skills • Good ...
Assess risk across various aspects ofsystems' functionsandfocus efforts on critical quality aspects ... Project Management & Leadership : Lead all aspects of client relationship development and project ...
Assess risk across various aspects ofsystems' functionsandfocus efforts on critical quality aspects ... Project Management & Leadership : Lead all aspects of client relationship development and project ...
Validation Engineer II
Carlsbad, CA · On-site
$30 - $32.47/hr
... Quality Systems Manual. Main Responsibilities Represent Client Division during internal and ... Manage the execution of validation protocols, as protocol directors, in assurance of timely and ...
Validation Engineer II
Carlsbad, CA · On-site
$30 - $32.47/hr
... Quality Systems Manual. Main Responsibilities Represent Client Division during internal and ... Manage the execution of validation protocols, as protocol directors, in assurance of timely and ...
Assess risk across various aspects ofsystems' functionsandfocus efforts on critical quality aspects ... Project Management & Leadership : Lead all aspects of client relationship development and project ...
Assess risk across various aspects ofsystems' functionsandfocus efforts on critical quality aspects ... Project Management & Leadership : Lead all aspects of client relationship development and project ...
Validation Engineer 1
$82K - $99K/yr
Build knowledge in additional areas of validation such as process validation, QC assets, computer ... Foundational understanding of validation principles, GMP requirements, and risk management concepts.
Validation Engineer 1
$82K - $99K/yr
Build knowledge in additional areas of validation such as process validation, QC assets, computer ... Foundational understanding of validation principles, GMP requirements, and risk management concepts.
Validation Engineer (Contract)
Indianapolis, IN · Hybrid
$80K - $150K/hr
Collaborate cross-functionally with Engineering, Quality, Manufacturing, and Regulatory teams to ... Ability to work independently, manage priorities, and contribute in a fast-paced environment.
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Validation Engineer (Contract)
Indianapolis, IN · Hybrid
$80K - $150K/hr
Collaborate cross-functionally with Engineering, Quality, Manufacturing, and Regulatory teams to ... Ability to work independently, manage priorities, and contribute in a fast-paced environment.
... the highest quality solutions with consistency and accuracy. What You'll Do You'll support both ... Project Management & Leadership : • Lead all aspects of client relationship development and ...
... the highest quality solutions with consistency and accuracy. What You'll Do You'll support both ... Project Management & Leadership : • Lead all aspects of client relationship development and ...
As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ... This position reports to the Sr. Manager, Technical Services. Responsibilities: * Provide guidance ...
As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ... This position reports to the Sr. Manager, Technical Services. Responsibilities: * Provide guidance ...
Manager Quality
Indianapolis, IN · On-site
... assigned Quality Management System (QMS) to ensure compliance with applicable regulatory ... Oversee validation and qualification activities, including equipment and systems validation ...
Manager Quality
Indianapolis, IN · On-site
... assigned Quality Management System (QMS) to ensure compliance with applicable regulatory ... Oversee validation and qualification activities, including equipment and systems validation ...
As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ... This position reports to the Sr. Manager, Technical Services. Responsibilities: * Provide guidance ...
As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ... This position reports to the Sr. Manager, Technical Services. Responsibilities: * Provide guidance ...
Process & Validation Expert
Indianapolis, IN · On-site
$97K - $146K/yr
Ensure that appropriate variables are identified for on-going monitoring as a contributor to quality risk management activities. * Author and review process, packaging or cleaning validation ...
Process & Validation Expert
Indianapolis, IN · On-site
$97K - $146K/yr
Ensure that appropriate variables are identified for on-going monitoring as a contributor to quality risk management activities. * Author and review process, packaging or cleaning validation ...
Quality Manager
Indianapolis, IN · On-site
$110K/yr
The Quality Manager works directly with Operations, Engineering, Supply Chain, and customers to ... validation, objective evidence, and routine process verification. • Support New Product ...
Quality Manager
Indianapolis, IN · On-site
$110K/yr
The Quality Manager works directly with Operations, Engineering, Supply Chain, and customers to ... validation, objective evidence, and routine process verification. • Support New Product ...
The Quality Manager works directly with Operations, Engineering, Supply Chain, and customers to ... validation, objective evidence, and routine process verification. · Support New Product ...
The Quality Manager works directly with Operations, Engineering, Supply Chain, and customers to ... validation, objective evidence, and routine process verification. · Support New Product ...
Quality Manager
$100K - $150K/yr
Quality Manager SUMMARY Mortenson is currently seeking an experienced Quality Manager with the ... No agency emails, calls, or solicitations are accepted without a valid agreement. * Must be ...
Quality Manager
$100K - $150K/yr
Quality Manager SUMMARY Mortenson is currently seeking an experienced Quality Manager with the ... No agency emails, calls, or solicitations are accepted without a valid agreement. * Must be ...
Quality Manager
Indianapolis, IN · On-site
$110K/yr
The Quality Manager works directly with Operations, Engineering, Supply Chain, and customers to ... validation, objective evidence, and routine process verification. · Support New Product ...
Quick apply
Quality Manager
Indianapolis, IN · On-site
$110K/yr
The Quality Manager works directly with Operations, Engineering, Supply Chain, and customers to ... validation, objective evidence, and routine process verification. · Support New Product ...
Quality Validation Manager information
What is the difference between Quality Validation Manager vs Quality Assurance Specialist?
| Aspect | Quality Validation Manager | Quality Assurance Specialist |
|---|---|---|
| Certifications | ISO 9001, Six Sigma, CQE | ISO 9001, Six Sigma, CQE |
| Work Environment | Manufacturing, pharmaceuticals, tech companies | Manufacturing, healthcare, software development |
| Responsibilities | Oversees validation processes, ensures compliance, manages validation teams | Performs audits, develops QA procedures, monitors quality metrics |
The main difference is that a Quality Validation Manager focuses on validating processes and systems to ensure compliance, often managing validation teams, while a Quality Assurance Specialist concentrates on implementing QA procedures, conducting audits, and maintaining quality standards. Both roles require similar certifications and are vital in industries like manufacturing and healthcare, but their core responsibilities differ in scope and focus.
What are popular job titles related to Quality Validation Manager jobs in Indiana? For Quality Validation Manager jobs in Indiana, the most frequently searched job titles are:
What job categories do people searching Quality Validation Manager jobs in Indiana look for? The top searched job categories for Quality Validation Manager jobs in Indiana are:
What cities in Indiana are hiring for Quality Validation Manager jobs? Cities in Indiana with the most Quality Validation Manager job openings:
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Posted 29 days ago
Job description
Title: Commissioning & Qualification (CQV) Lead – Manufacturing Expansion Location: IN Start Date: July 15th Duration: 12+ Months Role: We are seeking an experienced Commissioning & Qualification (CQV) Lead to support a large-scale pharmaceutical manufacturing expansion project within a GMP-regulated environment. This individual will serve as the primary CQV lead for a designated manufacturing, overseeing commissioning, qualification, startup readiness, and CQV execution activities from design through operational handoff. This is a highly visible leadership role responsible for driving CQV strategy, coordinating service providers, managing schedules, supporting FATs, overseeing qualification execution, and ensuring successful turnover of systems to operations. The CQV Lead will work closely with Engineering, Construction, Automation, Manufacturing, Validation, Quality, and Operational Readiness teams throughout the project lifecycle. Key Responsibilities: • Serve as the primary CQV lead and point of contact for assigned manufacturing systems and facilities • Develop and execute commissioning, qualification, and startup strategies for GMP manufacturing environments • Manage CQV schedules, project milestones, critical path activities, and readiness metrics • Coordinate commissioning and qualification activities across Engineering, Construction, Quality, Validation, Automation, and Operations teams • Support Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), turnover, and startup activities • Oversee execution of IQ, OQ, PQ, commissioning protocols, and qualification documentation • Manage service providers, contractors, and CQV resources supporting project execution • Coordinate pre-commissioning activities including calibration, automation downloads, utility startup, and system readiness • Review and approve qualification documentation, protocols, test scripts, deviations, and final reports • Lead change management activities and support project governance reviews • Support operational readiness initiatives and system handover to end users • Drive issue resolution, punch-list closure, risk assessments, and continuous improvement initiatives • Ensure compliance with GMP regulations, validation standards, and project quality requirements Preferred Background: • 10+ years of CQV, validation, engineering, or startup experience within pharmaceutical, biotech, or GMP-regulated manufacturing environments • Strong experience supporting large-scale capital projects and facility expansions • Extensive knowledge of commissioning, qualification, validation, and startup methodologies • Experience leading cross-functional teams and managing multiple stakeholders • Hands-on experience with GMP manufacturing facilities, utilities, process equipment, and automation systems • Familiarity with electronic validation systems such as Kneat or similar platforms • Experience supporting API, peptide, biologics, or sterile manufacturing operations preferred • Strong understanding of regulatory requirements, GMP documentation practices, and 21 CFR Part 11 • Ability to manage schedules, project risks, and contractor performance in a fast-paced project environment Skills: • Commissioning, Qualification & Validation (CQV) • IQ / OQ / PQ Protocol Development & Execution • GMP Manufacturing Startup & Operational Readiness • FAT, SAT & System Turnover Management • Facilities, Utilities & Process Equipment Qualification • Change Management & Risk Assessment • Construction, Engineering & CQV Coordination • Capital Project & Facility Expansion Support • Validation Documentation & Regulatory Compliance • Cross-Functional Leadership & Stakeholder Management