Validation Engineer (Computer Systems)
Fresenius Kabi —Melrose Park, IL
- $65,000 - $80,000 a year
- Full-time
- Background check
- English
- Mid-level
- Wellness program
- Paid holidays
Quick Apply
Product Engineer (PPG#337423)
Barton Staffing Solutions —Melrose Park, IL
- $80,000 - $90,000 a year
- Online Application
- Background check
- ERP systems
- Pass drug screening
- Health insurance
- Dental insurance
Quick Apply
13d
Validation Engineer (CQV, GMP, Life Sciences)
VBB —Chicago, IL
- $70,000 - $100,000 a year
- Full-time
- 5 years
- Engineering
- Travel
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Validation Engineer
Fresenius Kabi —Melrose Park, IL
- $65,000 - $80,000 a year
- Full-time
- Computer literacy
- English
- Mid-level
- Wellness program
- Paid holidays
6d
Quality Engineer
Fresenius Kabi —Melrose Park, IL
- $80,000 - $110,000 a year
- Full-time
- English
- Mid-level
- Wellness program
- Paid holidays
11d
Senior Electrical Engineer IV - Communications
OTTO Engineering —Carpentersville, IL
- $110,000 - $125,000 a year
- Online Application
- Customer service
- Research
- Mentoring
- Profit sharing
- Health savings account
Electrical Engineer III - Communications
OTTO Engineering —Carpentersville, IL
- $90,000 - $105,000 a year
- Online Application
- Customer service
- 5 years
- Senior level
- Profit sharing
- Health savings account
Fluids Engineer
CNH Industrial —Oak Brook, IL
- $86,625 - $132,825 a year
- Full-time
- Hybrid work
- 6 years
- Analysis skills
- Doctor of Philosophy
- Tuition reimbursement
- Adoption assistance
Lead Analog & RF Designer
NEO Technology Solutions —Naperville, IL
- $100,000 - $115,000 a year
- Full-time
- Background check
- Mentoring
- In-person
- Health savings account
- Health insurance
4d
Regulatory Quality Engineer
ARCH Medical Solutions —Elmhurst, IL
- From $90,310.67 a year
- Full-time
- 5 years
- Mid-level
- US work authorization
- Health savings account
- Health insurance
Quick Apply
12d
Engineering Technician
Bowman Analytics —Schaumburg, IL
- $65,000 a year
- Full-time
- Mid-level
- Ability to lift 50 pounds
- Travel
- Paid holidays
- Health insurance
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5d
Electrical Maintenance Engineer
Helukabel USA Inc. —West Dundee, IL
- $85,000 - $100,000 a year
- Full-time
- System design
- Mid-level
- Analysis skills
- Health savings account
- Health insurance
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5d
Staff Manufacturing Engineer
S & C Electric Company —Palatine, IL
- $116,534 - $154,413 a year
- Extended hours
- 7 years
- Analysis skills
- Mentoring
- Paid parental leave
- Health savings account
Systems Engineer
WITTENSTEIN North America —Bartlett, IL
- $90,000 - $120,000 a year
- Online Application
- Hybrid work
- System design
- Mid-level
- 3 years
- Profit sharing
- AD&D insurance
Vehicle System Integration Lead
HYDAC TECHNOLOGY CORPORATION —Glendale Heights, IL
- $130,000 - $145,000 a year
- 5 years
- Word processing
- Writing skills
- Paid holidays
- Disability insurance
Quick Apply
Sr. Engineer I
Val-Matic Valve & MFG. Corp —Elmhurst, IL
- $92,000 - $108,000 a year
- Background check
- 6 years
- Ability to walk for extended periods
- AD&D insurance
- Paid holidays
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13d
Quality Engineer
RTC —Rolling Meadows, IL
- 18 years or older
- Microsoft Excel
- Schematics
- Commuter assistance
- Paid parental leave
Process Engineer
AVLON INDUSTRIES —Melrose Park, IL
- $90,000 - $110,000 a year
- Full-time
- Background check
- Mid-level
- 3 years
- Health savings account
- Health insurance
Quick Apply
Sr. Mechanical Engineer - Converting
Pregis LLC —Aurora, IL
- $100,000 - $140,000 a year
- Full-time
- Analysis skills
- Continuous improvement
- Travel
Quick Apply
Senior Software Engineer
Contemporary Control Systems, Inc. —Downers Grove, IL
- $117,600 - $135,000 a year
- Full-time
- Computer science
- Computer Science
- Software troubleshooting
- AD&D insurance
- Disability insurance
Quick Apply

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validation engineer jobs near lisle, il

Validation Engineer (Computer Systems)

Fresenius Kabi -
Melrose Park, IL

Quick Apply

Job Details

Full-time
$65,000 - $80,000 a year

Benefits

Wellness program
Paid holidays
Health insurance
Dental insurance
401(k)
Employee assistance program
Vision insurance
Life insurance

Qualifications

Content creation for technical audiences
Technical documentation
Pharmaceutical regulatory compliance
Technical writing experience within manufacturing
English
Cleanroom protocols
Project management experience in manufacturing
Manufacturing facility experience
Production validation processes
Cleanroom experience
Productivity software
Production efficiency metrics
Sterile products production
Test validation method
FDA regulations
Pharmaceutical manufacturing facility experience

Full Job Description

Job Summary

THIS JOB IS A FULL-TIME ONSITE POSITION, NO CONTRACT WORK AVAILABLE.

THIS JOB IS NOT ELIGIBLE FOR VISA SPONSORSHIP NOW OR IN THE FUTURE.

Salary: $65,000 to $80,000

Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.

Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage. Read more about our benefits here.

Responsibilities

The Validation Engineer is specialized in computerized systems validation and knowledgeable in MES (EBR) , historian(QMIB), LAB -X and other manufacturing applications. Provides technical & documentation support for manufacturing process and associated computer systems. Also compliance knowledge on various aseptic manufacturing processes (sterilization, isolator technology, clean rooms, computerized systems, etc). Uses his/her expertise to maintain industry standards within the company.

The focus of the Validation Engineer is on technical and documentation aspects of the department and typically does not have direct report. The Validation Engineer must have excellent verbal and written communication skills as this position interacts directly with multiple departments at the site, regional and global levels.

Job Responsibilities:

Schedules and executes computer system qualifications per Standard Operating Procedures (SOPs). Coordinates and communicates all testing with affected functional groups and evaluates test results. Assembles and composes the final report and circulates for approval.
Executes validation studies (utility, equipment, cleaning, process, computer, and new products) to include protocol preparation, scheduling, protocol execution, and final report preparation. Presents results to Regulatory Agency when necessary.
Participates in dry running the manufacturing system applications and develops the test scenarios, test environments, test scripts.
Develops and updates full life cycle documents includes, URS, FDS, DS, risk assessments, impact assessment, FMEAs and test and qualification protocols.
Develops/improves validation programs as needed to remain current with cGMPs and industry standards
Represents Technical Services in teams assembled to specify, install, validate, troubleshoot and maintain systems, equipment and processes.
Conducts and/or participates in deviation investigations to identify root causes and define corrective and/or preventative actions (CA/PA).
Authors validation master plans and validation project plans outlining qualification requirements
Authors the documentation needed for MES(EBR), Historian(QMIB), manufacturing applications and infrastructure like industrial data center, etc.
Provides technical support for Investigations, Action Plans, Change Controls and Risk Assessments as required. Generates innovative solutions to solve difficult problems that may impact multiple disciplines
Additional projects and tasks as assigned.
All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities

Job Requirements:

Bachelor’s Degree in a Science or Engineering field of study
Minimum of one year of related experience in a cGMP facility, including experience with FDA regulations, medical, drug and device products.
Installation, Operational and Performance Qualification protocol generation and execution experience
Knowledge and understanding of cGMPs, industry guidance, and aseptic techniques
Excellent technical writing and verbal communication skills. Experienced in negotiating.
Understanding of MES(EBR), historian, oee, and other manufacturing applications.
PC literate with standard office application (Word, Excel, PowerPoint, Project, Access) competency
Good communication skills and leadership skills.
Good judgment and decision skills.
Problem solving and multi-tasking.
Project supervision and project management skills.
Ability to work independently.
Ability to adapt and handle change.
Knowledge of cGMP Process and Product Validation requirements and techniques.

The Company’s primary business language is English. The successful candidate must be able to effectively speak, read, write, and understand English to perform the essential functions of the position, including independently understanding policies, procedures, training materials, and workplace communications written in English due to our heavily regulated work environment.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at‑will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Work Location: In person

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Refine Your Search

validation engineer jobs in lisle, il

Validation Engineer (Computer Systems)

Product Engineer (PPG#337423)

Validation Engineer (CQV, GMP, Life Sciences)

Validation Engineer

Quality Engineer

Senior Electrical Engineer IV - Communications

Electrical Engineer III - Communications

Fluids Engineer

Lead Analog & RF Designer

Regulatory Quality Engineer

Engineering Technician

Electrical Maintenance Engineer

Staff Manufacturing Engineer

Systems Engineer

Vehicle System Integration Lead

Sr. Engineer I

Quality Engineer

Process Engineer

Sr. Mechanical Engineer - Converting

Senior Software Engineer

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