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ATS Company:  ATS Automation Tooling Systems
Requisition ID:  8013
Location: 

Rolling Meadows, IL, US, 60008-3833

Date:  Nov 22, 2022

Validation Engineer II

OBJECTIVE: Under minimal direction, provide the coordination, creation and execution of validation activities including (but not limited to) writing protocols, performing qualifications, review of documents that support the manufacturing of automated equipment on a large single module custom machine or small multi-module custom system or replication project. In addition, the candidate will have to understand how the various pieces of automated equipment operate and understand the principle of Validation and Engineering.

 


RESPONSIBILITIES:

 

  •  Generate Functional, Software, and Hardware Design Specifications; Risk Assessments; Traceability Matrices; Installation and Operational Verification protocols; and other Commissioning and Qualification documentation as needed per customer requirements for build-to-print and small projects.
  •  Execute test protocols and close with final summary reports.
  •  Facilitate internal and customer design reviews.
  •  Support the creation of technical documentation for projects where required.
  •  Ensure that applicable regulations, guidelines and company procedures are followed and applied during all stages of project activities.
  •  Work with cross-functional teams (e.g., Engineering, Manufacturing, and Project Management) to evaluate and set milestones to ensure projects are on schedule and meet customer needs.
  •  Assist in resolving and documenting technical and project-related issues.
  •  Maintain International Standardization Organization (ISO) standards.
  •  Other duties as assigned.

 

 

QUALIFICATIONS:


Education:

  •  Bachelor of Science degree in technical field.

 

Experience Required:

  •  Minimum 5 years of experience in a FDA Regulated environment.
  •  21 CFR Part 211/820 or ISO 13485:2016.
  •  Technical understanding of CQV practices related to the pharmaceutical industry.
  •  Expertise in interpretation of applicable regulations and industry guidance documents used in cGMP/GxP environments (e.g., CFRs, ICH, ISPE, ISO, etc.).
  •  Knowledgeable in testing principles, manufacturing processes, quality systems, engineering design fundamentals, regulatory agency expectations and industry trends.
  •  Experience with automated manufacturing equipment.
  •  Basic understanding of Allen-Bradley PLCs and HMIs


Experience Preferred:

  •  Basic understanding of SolidWorks and AutoCAD.
  •  Flexible and willing to perform a variety of tasks to meet the needs of the business.


Skills Required:

  •  Strong English grammar skills.
  •  Strong commitment to quality and accuracy.
  •  Detail-oriented.
  •  Proficient with Microsoft Office.
  •  Strong technical writing, verbal communication, interpersonal and problem-solving skills.
  •  Ability to thrive in a cross-functional team environment.


 

PHYSICAL DEMANDS:

 

  • The employee may be required to stand, walk, push, pull, reach overhead, and bend to the floor.
  • Exert up to 50 pounds of force occasionally, and/or exert up to 10 pounds of force frequently.
  • Visual Acuity – Normal requirements for reading written instructions and computer screens
  •  Hearing Ability – Normal requirements for understanding verbal instructions.
  •  Working Conditions – The employee is subject to a normal office environment with occasional exposure to high noise levels and/or physical hazards when visiting manufacturing floor.
  •  Capable of wearing appropriate related PPE for extended periods

 

 

We are an equal employment employer. All applicants considered are subject to a pre-employment screening.
We thank all applicants for their interest, however only those candidates selected for interviews will be contacted.
Being authorized to work in the U.S. is a precondition of employment.  Our company is not able to provide sponsorship to candidates wanting to work legally in the United States and needing an H1-B Visa.

 

Join the Winning Team at ATS Automation, a great place to automate your future! Take your place among the best in the business, and grow your career with the Life Science Chicago division at ATS. We attract some of the most talented and motivated individuals from a range of fields, with our global offering and growth opportunities as we expand throughout the world.  We want you to be a part of our TEAM!!!  Watch us work here! 

 

New Link https://www.youtube.com/watch?v=9Yb_JLb6pwQ&t=64s

 

Work in an environment where a passion for innovation is combined with an uncompromised commitment to quality.

 

Benefits ATS Life Sciences Chicago offers:

  • Competitive compensation package
  • Comprehensive benefits (including health, dental vision and employee assistance program)
  • Employee Stock Purchase Plan Eligibility
  • 401k with employer match
  • Tuition reimbursement
  • Wellness reimbursement
  • Paid time off
  • Annual paid volunteer day off
  • Fully climate-controlled environment
  • Professional growth opportunities
  • And more!

Apply now »