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Validation engineer • usa
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Role : Validation Engineer - Manufacturing Operations </b></p> <p><b>Location : North Haven, CT (Onsite)</b></p> <p><b>NEED SOMEONE WITH PRIOR MEDTR...[show_more][last_updated.last_updated_variable_days]
This is a hands-on, onsite role focused on equipment installation, IQ/OQ execution, and validation documentation within a regulated manufacturing environment (ISO / ISO ).The team is looking for so...[show_more][last_updated.last_updated_variable_days]
The Validation Engineer is responsible for verifying after-treatment designs to meet system-level design specifications, and reliability targets.The position includes the implementation of Design f...[show_more][last_updated.last_updated_30]
A validation and quality assurance provider is looking to hire.Veeva Vault and/or ValGenesis experience, this is a plus.The ideal candidate will have firsthand experience in qualifying, generating,...[show_more][last_updated.last_updated_variable_days]
Responsibilities: Provide validation experience and guidance during equipment design, software design, build, debug, and qualification phases of a project.Write overall project quality (validation ...[show_more][last_updated.last_updated_30] Designs, engineers, and implements quality systems to ensure regulatory compliance and quality improvements.This includes designing, planning, and executing validation activities for Over the Count...[show_more][last_updated.last_updated_30] 
The Validation Engineering Specialist is responsible for executing qualification and validation activities supporting Over the Counter OTC pharmaceutical and personal care products, including sunsc...[show_more][last_updated.last_updated_variable_days] With direct supervision, candidate is responsible for support and execution of QC laboratory equipment qualification activities while in full compliance with current cGMP regulations and Roche/Gene...[show_more][last_updated.last_updated_30] 
BS in CS/Engineering | Linux/Servers/BIOS | Python scripting.Hands-on engineer validating datacenter server power management features from silicon/SoC through BIOS/firmware/OS levels on server prod...[show_more][last_updated.last_updated_variable_days]
Job Summary Responsible for the validation of facility utilities, and equipment processes for cGMP products such as pharmaceuticals, medical devices, and cosmetic products to adhere to 21 CFR 211/2...[show_more][last_updated.last_updated_variable_days]
At Molex, a global leader in connectivity solutions, we’re seeking a.DVP&R) that meet automotive industry standards.You’ll coordinate with global labs to ensure smooth test execution, lead test tea...[show_more][last_updated.last_updated_variable_days]
Job Posting Start Date 02-16-2026 Job Posting End DateFlex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that imp...[show_more][last_updated.last_updated_30]
The Entry-Level Validation Engineer will support execution of validation activities for the MDT Validation Remediation Project at the Middletown site.This role is project-specific and requires full...[show_more][last_updated.last_updated_1_day]
Responsibilities of the Validation Engineer include:.Lead validation activities for automated systems and support CSV deliverables across a regulated production environment.Oversee and execute proc...[show_more][last_updated.last_updated_1_day]
Position: Validation Engineer Location: Boca Raton, FL*Day 1 Onsite [show_more][last_updated.last_updated_variable_days]
Shift: 1st shift, Monday-Friday.MDT Validation Remediation Project at the Middletown site.This role is project-specific and requires full onsite presence to support equipment, process, and system v...[show_more][last_updated.last_updated_variable_days]
A validation and quality assurance provider is looking to hire.Veeva Vault and/or ValGenesis experience, this is a plus.The ideal candidate will have firsthand experience in qualifying, generating,...[show_more][last_updated.last_updated_variable_days]
Responsible for Validation/PPAP Packages on new customer programs, as well as ensuring compliance is applicable regulatory bodies and standards (ISO13485, 21 CFR 820, GMP).Requires a 4-yr engineeri...[show_more][last_updated.last_updated_30]
Manages projects of varying scope and complexity.Supports laboratory and manufacturing equipment implementation projects including scheduling, procurement, site prep, installation, qualification, a...[show_more][last_updated.last_updated_30]
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Role : Validation Engineer - Manufacturing Operations
Location : North Haven, CT (Onsite)
NEED SOMEONE WITH PRIOR MEDTRONIC EXPERIENCE
Soft Skills
- Strong ownership mindset with the ability to lead cross-functional teams under regulated constraints.
- Effective communicator with experience presenting technical content to leadership, quality, and regulatory teams.
- Ability to manage multiple priorities, drive structured problem-solving, and implement scalable engineering solutions.
________________________________________
Key Responsibilities
- Oversee and optimize complex production processes for surgical devices, ensuring alignment with efficiency and quality standards.
- Act as the primary technical expert for electro-mechanical equipment issues, identifying root causes and implementing sustainable corrective actions to minimize downtime.
- Lead the development and execution of validation strategies, including Installation, Operational, and Performance Qualifications (IQ/OQ/PQ) for new and existing equipment.
- Apply Lean principles to identify opportunities for waste reduction and process stability.
- Lead non-conformance (NCMR) and Corrective and Preventive Action (CAPA) investigations to uphold strict quality system requirements.
- Support the adaptation of machine or equipment design to factory and production conditions
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Required Qualifications
- Bachelor's degree in Electrical Engineering, Controls, Automation, Mechatronics, or related field.
- 10+ years of relevant manufacturing engineering experience (or 8+ years with a Master's degree).
- Mastery of medical device process validation (IQ/OQ/PQ), statistical analysis (Minitab), and high-volume manufacturing assembly.
- Proven ability to troubleshoot complex automated systems including robotics, motion control, and machine vision.
- Strong background in statistical analysis, including process capability, process control, DOE, and inspection design In-depth understanding of Production Part Approval Process (PPAP) for component qualification
Qualification:
- Bachelor's degree in Electrical Engineering, Controls, Automation, Mechatronics, or related field.
Pi-square technologies is a Michigan (USA) Headquartered Automotive Embedded Engineering Services company, Synergy Partner for major OEMs and Tier 1s and their implementation partners in Automotive Embedded Product Development, Projects, Requirements Analysis, Software Design, Software Implementation, Efficient Build, Release Process, and turnkey software V & V Services. We have more than 20+ years of industry expertise with specialization in the latest cutting-edge automotive technologies such as Infotainment, connected vehicles, Cyber security, OTA, and Advanced Safety/ Body electronics.