20 Best Validation Engineer jobs (Hiring Now!)

Validation Engineer (Urgently Hiring)
PCI Pharma Services —Rockford, IL
Conduct and/or participate in customer conference calls, customer/regulatory audits and inspections, and face-to-face meetings.
$67,421.80 - $90,000.00 a year
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22h
PCBA Quality Engineer
Hyve Solutions —Carson City, NV
Monitor departmental activities and provide technical and logistical guidance/support for the quality engineering staff as applicable.
$56,000 - $97,000 a year
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Validation Engineer 1st shift
Armstrong Pharmaceuticals —Canton, MA
EDUCATION and/or EXPERIENCE:* Bachelor's degree (B. S.) from four‑year college or university in physical science/engineering, biological science or related…
$31.25 - $40.87 an hour
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Quality Engineer
UFP Technologies —Chicopee, MA
4 year college degree in related field. Completes special testing when required for failure analysis, validations, etc. 401K with a matching contribution.
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Commissioning Engineer, AMER-Central ACx
Amazon Data Services, Inc. —Dublin, OH
Understand the design concept and intent by reviewing mechanical or electrical design documentation, including drawings, specifications, vendor submittals and…
Estimated: $92.1K - $117K a year
Special Exceptions Engineer
Manpower Engineering —Portland, OR
Bachelor’s degree in Engineering or related field. Support production facilities and test instances, providing technical expertise and troubleshooting.
$58 - $63 an hour
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3d
Validation Engineer
Stellar Consulting Group —Austin, TX
List 3-5 hard requirements for the role: Developing validation protocols (IQ/OQ/PQ/TMV), driving strategy to resolve unexpected results, driving validation…
$48 - $52 an hour
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3h
Controls Systems Engineer
Midwest Engineered Systems, Inc —Waukesha, WI
Our ideal candidate will have a minimum of an Associate’s Degree in a related field, such as electrical or control systems engineering, automation technology…
$80,000 - $120,000 a year
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Quality Engineer
Jedco Inc. —Grand Rapids, MI
High School Diploma (minimum), Bachelors Degree or equivalent technical/engineering training preferred. Experience or training in risk management and analysis…
Estimated: $58.3K - $73.8K a year
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Validation Engineer
Bobbie —Heath, OH
Organize project work, source vendors, supervise contractors onsite, and contribute to process and equipment design.
$120,000 - $140,000 a year
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Quality Engineer
Oshkosh Defense LLC —Spartanburg, SC
Bachelor's degree in Quality, Business, Operations Management, or related field. Analyze process constraints and develop standards to overcome constraints.
Estimated: $71.4K - $90.4K a year
Communications Engineer (Joint and Services Center)
The MITRE Corporation —Lexington Park, MD
Independent reviews of communications system designs and their integration into naval aircraft including analysis of alternatives, design reviews, and…
Estimated: $157K - $199K a year
Senior Power System Controls Engineer
Schweitzer Engineering Laboratories —Pullman, WA
Train and assist customers with the creation, design, configuration, validation, installation, commissioning and operation of automation and/or protection…
$91,100 - $142,700 a year
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3d
Sr. Systems Engineer
Supernal —Irvine, CA
Bachelor’s degree in aerospace, electrical, or a relevant engineering field required. Minimum five (5) years of experience in powertrain/propulsion systems…
$180,100 - $218,300 a year
Manufacturing Engineer
4Front Solutions —DeLand, FL
Prepare processes, drawings, and develop tools for manufacturing processes in order to generate or improve efficient production throughput.
Estimated: $66.7K - $84.5K a year
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4d
Validation Engineer
Unicon Pharma, Inc —United States
Develop and execute the validation master plan, validation project plan, risk assessment, user requirements, design qualification and life cycle documents for…
$30 - $45 an hour
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Senior Process Engineer
The Haartz Corporation —Acton, MA
Assist manufacturing with addressing mechanical, engineering and production issues. Bachelor's degree (B.S.); accredited in a technical discipline, such as…
Estimated: $96.9K - $123K a year
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Validation Engineer
Comtec Information System —Remote
Work closely with other validation team members to ensure system impact is assessed and mitigation strategy is in place for multiple sites using the LIMS…
Estimated: $99.3K - $126K a year
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4d
Validation Engineer
Katalyst Healthcares & Life Sciences Inc —Cambridge, MA
Provide input to technical / investigation reports. Identify, troubleshoot, and propose a resolution to technical problems.
Estimated: $86.5K - $110K a year
Quick Apply
6d
Quality Engineer III - Quality Manager
Precision Edge Surgical Products Company LLC —Boyne City, MI
Perform hazard and risk analysis for new legacy products, including FMEA and decision tree analysis. ASQ Certified Quality Engineer certification (preferred).
Estimated: $86.7K - $110K a year
5d

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Validation Engineer (Urgently Hiring)

PCI Pharma Services - Rockford, IL

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Job Details

Full-time $67,421.80 - $90,000.00 a year 22 hours ago

Benefits

Health insurance
Dental insurance
401(k)
Flexible spending account
Tuition reimbursement
Paid time off
Employee assistance program
Vision insurance
401(k) matching
Life insurance
Referral program

Qualifications

Microsoft Powerpoint
Microsoft Word
Statistical software
Feature validation testing
CGMP
Microsoft Excel
Microsoft Access
PCI
Engineering
GMP
Windows
Minitab
Bachelor's degree
Packaging
Technical writing
Computer skills
4 years
Communication skills

Full Job Description

Summary of Objective:

The Validation Engineer is responsible for the qualification/validation of pharmaceutical equipment, processes, and test methods for the assembly, inspection, testing, and packaging of medical devices. Core functions include management of validation projects, generation and execution of validation protocols, evaluation of statistical criteria to determine validation acceptance, direct interface with internal/external customers/regulatory agencies, and determination of external customer validation needs. Requires the ability to work with other departments to define, prioritize, schedule, and complete validation projects such that PCI’s internal/external compliance standards and production targets are achieved. Occasional overtime/weekend work is required.

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

Write, review, and/or execute validation documentation (e.g., Installation/Operation/Performance/Test Method Qualification protocols, parameter pages, statements, risk assessments) for the assembly, inspection, testing, and packaging of medical devices to assure compliance with regulatory, internal, and customer requirements.
Ensure efficient validation documentation completion, accuracy, and closure, including organizing and coordinating multiple approvals in a timely manner as required.
Serve as the primary validation representative for medical device packaging and assembly. Conduct and/or participate in customer conference calls, customer/regulatory audits and inspections, and face-to-face meetings.
Interact with Sales, Project Management, Engineering, Maintenance, Production, Technical Services, Quality Assurance, and external customers to determine requirements for new projects
Effectively communicate project goals and progress to internal/external clients. Investigate deviations, document in formal reports, and assure resolution of corrective action to complete the validation.
Participate in the change management process, outline requirements for validation through impact assessments, and prepare change control and validation history reports for audits.
Review and approve pre-validation documents including, but not limited to, User Requirement/Acceptance Testing, Factory/Site Acceptance Testing, Engineering Studies, and batch records/packaging instructions.
Apply engineering and statistical principles, theories, and techniques proficiently to support the validation of equipment, processes, and test methods for medical device assembly, inspection, testing, and packaging.
Measure characteristics of medical devices (e.g, force, time, weight, length) and apply statistical methods (e.g., Gage Repeatability and Reproducibility (Gage R&R), Attribute Agreement Analysis, Cluster Analysis, One-Way Analysis of Variance (ANOVA)) for determining and evaluating acceptance criteria.
Support the validation of new technology/instrumentation with a focus on Data Integrity principles.
May participate and/or assist in conducting Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT) to qualify new equipment.
Will be required to complete and pass GDP and GMP training courses.
This position may require overtime and/or weekend work.
Attendance to work is an essential function of this position.
This position may require extra hours and/or weekend work.
Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules, and requirements.
Performs other duties as assigned by Manager/Supervisor.

Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodation may be made to enable individuals with disabilities to perform essential functions.

Required:

Bachelor's Degree in a related field and/or 4-5 years of related experience and/or training.
MUST HAVE experience with the development and execution of validation protocols in the pharmaceutical and/or medical device industry.
Statistical and Advanced Mathematical Skills
Intermediate Computer Skills: Ability to perform more complex computer tasks and know various computer programs.
Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
Highest Reasoning Ability: Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems and deal with nonverbal symbolism in its most difficult phases while dealing with concrete/abstract variables.
Ability to work on multiple projects at the same time.
Ability to meet aggressive timelines.
Good interpersonal/teamwork skills.
Effective communication skills (verbal and written form).
Good documentation practice.
Proficient in the use of computer software - Microsoft (Windows, Word, Excel, Outlook, PowerPoint), Minitab Statistical Software, and SPC software.

Preferred:

Ability to effectively present information to various people as the job requires.
Ability to identify and resolve problems promptly.
Ability to display original thinking and creativity.
Ability to show success in managing employees.
Ability to demonstrate attention to detail.
Ability to set and achieve challenging goals.

#LI-SW1

_\_

#IND-HP

Job Type: Full-time

Pay: $67,421.80 - $90,000.00 per year

Benefits:

401(k)
401(k) matching
Dental insurance
Employee assistance program
Flexible spending account
Health insurance
Life insurance
Paid time off
Referral program
Tuition reimbursement
Vision insurance

Work setting:

In-person

Ability to Relocate:

Rockford, IL: Relocate before starting work (Required)

Work Location: In person

Quick Apply

Validation Engineer jobs

Validation Engineer (Urgently Hiring)

PCBA Quality Engineer

Validation Engineer 1st shift

Quality Engineer

Commissioning Engineer, AMER-Central ACx

Special Exceptions Engineer

Validation Engineer

Controls Systems Engineer

Quality Engineer

Validation Engineer

Quality Engineer

Communications Engineer (Joint and Services Center)

Senior Power System Controls Engineer

Sr. Systems Engineer

Manufacturing Engineer

Validation Engineer

Senior Process Engineer

Validation Engineer

Validation Engineer

Quality Engineer III - Quality Manager

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