Validation Engineer jobs in Janesville, WI

Validation Engineer prepares all protocols and reports for validation work. Coordinates all validation activities by constant communication with affected departments and personnel; oversees and reviews validation area processes and procedures. Being a Validation Engineer may require a bachelor's degree. Typically reports to a manager or head of a unit/department. The Validation Engineer works on projects/matters of limited complexity in a support role. Work is closely managed. To be a Validation Engineer typically requires 0-2 years of related experience. (Copyright 2024 Salary.com)

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Validation Engineer
  • PCI Pharma Services
  • Rockford, IL FULL_TIME
  • Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.


    We are PCI.


    Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

    Summary of Objective:

    The Validation Engineer is responsible for overall validation project ownership of high through low-risk project(s) under limited to no supervision. Responsible for generation and execution of validation protocols, assistance in audits, determination of validation needs, and training of Analysts. This job has no supervisory responsibilities.

    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.

    • Performs validation activities to ensure compliance with government and customer requirements.
    • Prepares and executes validation protocols (IOQ, OQ/PQ) and validation standards, validation statements, reports, summaries, and master validation plans for new customer/product/system project launch and maintains existing validated processes and coordinating internal and customer approvals, as needed.
    • Ensures validation documentation completion, accuracy, and closure, including organizing and coordinating multiple approvals as required.
    • Assist in the Change Control process, and prepare change control and validation history reports for audits.
    • Attends conference calls and meetings.
    • Effectively communicates project goals and progress to Supervisor / Manager. Investigates validation deviations, documenting in formal reports, and assuring resolution of corrective action to complete the project.
    • Reviews and interprets standards, procedures, and specifications for dissemination relative to validation protocols.
    • Review and approve User Requirement Specifications, Functional Specifications, and Engineering Study Protocols Review and possibly assist in Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT) to qualify equipment Harmonization/streamlining of validation activities Coordinate validation efforts with mechanics, operators, and engineering Knowledge of and adherence to all PCI, cGMP, GCP, GAMP, 21CFR, 21CFR Part 11 and Annex 11 policies, procedures, rules, and requirements.
    • 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.
    • Performs other duties assigned. High-risk projects" are generally defined as projects/customer accounts that have the following.
    • Business needs of customers/projects may require considerable time commitments.
    • High level of uncertainty in managing customer expectations.
    • Have a validation approach with significantly more or more complex requirements in addition to the Validation Master Plan.
    • May or may not have established criteria, which may be subject to interpretation.

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

    Required:

    • Bachelor's Degree in a related field and/or 1-3 years of related experience and/or training.
    • College Level Mathematical Skills
    • Experience with the development and execution of validation protocols for process, equipment, cleaning, and computer systems in the pharmaceutical and/or medical device industry
    • 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 practices
    • Proficient in the use of computer software - Microsoft Windows, Microsoft Word, Microsoft Excel, Microsoft Access, SPC software, and Microsoft PowerPoint
    • Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
    • High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms.

    Preferred:

    • Process/Cleaning Validation Focus: Background in Packaging, Pharmaceutical, Bio-Pharmaceutical, and/or Medical Devices. Must be able to properly gown and work in an active packaging operation.
    • HVAC/Utility/Facilities Validation Focus: Familiarity with HVAC wiring diagrams, control design, calibration, instrument configuration, and a high understanding of heating, air conditioning, and refrigeration systems.
    • Computer Validation Focus: Ability to perform highly complex computer tasks and have experience with computer systems considered to have an impact on cGMP, cGMP, Annex 11, and PCI guidelines.

    LI-SW1

    Join us and be part of building the bridge between life changing therapies and patients.

    Equal Employment Opportunity (EEO) Statement:
    PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.


    LSNE is an EEO/AA Employer and all qualified applicants will receive consideration for employment without regard to, their race, color, religion, sex, age, national origin, ancestry, sexual orientation, gender identity, disability, protected genetic information, protected veteran status, military service, or other protected status. The Company’s EEO policy, as well as its affirmative action obligations, include the full and complete support of The Company.

     

  • 16 Days Ago

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Verification and Validation Engineer
  • Ventures Unlimited Inc.
  • Rockford, IL FULL_TIME
  • Company DescriptionVUI since 2004 has been helping clients improve their business, environmental and social performance. We do this by applying innovative processes, market intelligence and fresh thin...
  • 1 Month Ago

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SSI Technologies: Validation Test Engineer
  • SSI Technologies
  • Janesville, WI FULL_TIME
  • SSI Technologies: Validation Test Engineer Janesville, WI, USA Req #11616 Friday, March 15, 2024 Position Summary: Responsible for development and continuous improvement of products to prevent future ...
  • 1 Month Ago

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Validation Analyst 1 (Computer System Validation Analyst)
  • PCI Pharma Services
  • Rockford, IL FULL_TIME
  • Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.We are PCI.Our investment is in People who make an impact, drive progress and create a better tomo...
  • 24 Days Ago

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Supervisor, Quality Validation
  • PCI Pharma Services
  • Rockford, IL FULL_TIME
  • Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.We are PCI.Our investment is in People who make an impact, drive progress and create a better tomo...
  • 20 Days Ago

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Validation Analyst 1
  • PCI Pharma Services
  • Rockford, IL FULL_TIME
  • Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.We are PCI. Our investment is in People who make an impact, drive progress and create a better tom...
  • Just Posted

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0 Validation Engineer jobs found in Janesville, WI area

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Validation Engineer
  • Ima Automation
  • Loves Park, IL
  • IMA Automation North America designs and builds turn-key assembly solutions for the medical device automotive and other ...
  • 4/26/2024 12:00:00 AM

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Mechanical Engineer II
  • Intelliswift Software
  • Stoughton, WI
  • Job title: Mechanical Engineer II Location: Stoughton WI 53589 Duration:12+ months (Possibility of extension) Pay rate: ...
  • 4/26/2024 12:00:00 AM

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Senior Project Engineer
  • Technosmarts Inc.
  • Jefferson, WI
  • W2 ONLY. 18 month renewable term contract. Potential to extend multi-year/option to hire. 2nd shift: 4:00PM - 6:00AM (60...
  • 4/26/2024 12:00:00 AM

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Engineering Manager
  • Rock Energy Cooperative
  • Beloit, WI
  • Rock Energy Cooperative is looking for an Electrical Engineering Manager who has experience with Electrical Power Distri...
  • 4/25/2024 12:00:00 AM

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Process Engineer
  • GEA
  • Janesville, WI
  • GEA is one of the world’s largest systems suppliers for the food, beverage, and pharmaceutical sectors. Approximately 18...
  • 4/25/2024 12:00:00 AM

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Validation Engineer
  • IMA AUTOMATION
  • Loves Park, IL
  • IMA Automation North America designs and builds turn-key assembly solutions for the medical device automotive and other ...
  • 4/22/2024 12:00:00 AM

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Process Engineer
  • GEA
  • Janesville, WI
  • GEA is one of the world’s largest systems suppliers for the food, beverage, and pharmaceutical sectors. Approximately 18...
  • 4/22/2024 12:00:00 AM

I
Mechanical Engineer II
  • Intelliswift Software
  • Stoughton, WI
  • Job title: Mechanical Engineer II Location: Stoughton WI 53589 Duration:12+ months (Possibility of extension) Pay rate: ...
  • 4/22/2024 12:00:00 AM

Janesville is a city in southern Wisconsin, United States. It is the county seat and largest city of Rock County, and the principal municipality of the Janesville, Wisconsin, Metropolitan Statistical Area. As of the 2010 census, the city had a population of 63,575. According to the United States Census Bureau, the city has a total area of 34.45 square miles (89.23 km2), of which 33.86 square miles (87.70 km2) is land and 0.59 square miles (1.53 km2) is water. The city is divided by the Rock River....
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Validation Engineer jobs
$54,418 to $72,692
Janesville, Wisconsin area prices
were up 1.3% from a year ago

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