
Job Information
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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