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Randstad Validation Engineering Professional in Kalamazoo, Michigan

Validation Engineering Professional

job details:

  • location:Kalamazoo, MI

  • salary:$45 - $64.28 per hour

  • date posted:Tuesday, February 23, 2021

  • job type:Contract

  • industry:Professional, Scientific, and Technical Services

  • reference:823382

job description

Validation Engineering Professional

job summary:

A Validation Engineering Professional is needed for an engineering consulting company in the Kalamazoo, MI area. This job will provide CSV/CQV support to clients that manufacture GMP products on a consistent basis in conjunction with industry best practices:

location: Kalamazoo, Michigan

job type: Contract

salary: $45.00 - 64.28 per hour

work hours: 8am to 5pm

education: Bachelors

responsibilities:

  • Develop CSV/CQV planning documents to manage CQV projects

  • Generate and execute CSV/CQV protocols (IQ/OQ/PQ) using Good Documentation Practices (GDPs)

  • Investigate and resolve protocol exceptions or discrepancies

  • Develop technical reports and CSV/CQV summary reports

  • Startup equipment and systems in a safe and effective manner

  • Develop GxP computer validation and CFR 21 Part 11 related documentation such as assessments, plans, URS, FRS and summary reports

  • Perform risk assessments and impact assessments

  • Apply engineering knowledge of, and experience with, manufacturing equipment, process equipment, HVAC, utilities, instrumentation, controls, and automation to support clients

Qualifications:

Minimum Qualifications:

The ideal candidate for this position will possess the following:

  • BS Chemical, Mechanical, Electrical or Computer Engineering or equivalent

  • 5-10 years of CSV experience in the life sciences industry

  • Understanding of Good Manufacturing Practices (GMPs)

  • Technical writing skills

  • Proficient with Microsoft Office - Word, Excel, PowerPoint, Project

  • Flexibility and willingness to travel and work at various clients' locations

  • Ability to work well with diverse, multi-disciplined groups

  • Ability to effectively communicate with management and fellow project team members

  • Ability to negotiate/compromise with other project team members to achieve project goals

  • Ability to listen and respect fellow project team member's ideas and opinions and work through conflicts or disagreements

Preferred Qualifications:

  • Experience with Aseptic Fill/Finish lines

  • Experience with Freeze Dryers

  • Experience with qualifying SCADA systems

  • Experience with qualifying Delta V systems

  • Experience with qualifying BAS and BMS system

#LI-PM2

qualifications:

  • Experience level: Experienced

  • Minimum 5 years of experience

  • Education: Bachelors (required)

skills:

  • Validation

  • Manufacturing

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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