Overview
On Site
Accepts corp to corp applications
Contract - Independent
Contract - W2
Contract - 6+ MO
Skills
Skype
Regulatory Compliance
Design Review
Mechanical Engineering
Mapping
Leadership
Documentation
Testing
Collaboration
Change Control
Science
Project Management
Communication
Presentations
Pharmaceutics
Manufacturing
Good Manufacturing Practice
Oracle UCM
SANS
OM
IMG
Job Details
CQV Engineer(Onsite)
Location:Kalamazoo, Michigan
Interview:Phone+Skype
Job Description:
Overview:
The qualified Validation Engineer will support multiple workstreams including prep/form, fill/freeze dry, utilities, etc. While these are the key workstreams, the ability to shift priorities and prove experience across a range of equipment is highly desired. The ideal candidate should hold large scale aseptic Process Equipment C&V experience, needs to be independent with insightful understanding of core C&V requirements, and must have a proactive understanding of required actions / deliverables.
Senior Validation Engineer Responsibilities:
Operate according to SOPs developed for MAP Project Qualification strategy and general GEP / cGMP compliance
Provide or arrange for development of complete verification documentation in accordance with Quality Standards and cGMP requirements for assigned projects
Raise and Implement system change controls as required
Develop and implement changes required to resolve deviations/ non conformances effectively
Participate in design review for new/ modified utility systems
Participate in construction system mechanical completion walkdowns
Author and perform execution of Verification Testing (Qualification) Protocols (VTPs) in field
Assist with execution of temperature mapping of equipment
Assist with pre and post study calibration verifications
Effectively interact with leadership and partner with Engineering Verification, Engineering Project Management, Automation, Maintenance, Operations, and Quality stakeholders to establish priorities and define verification documentation and testing requirements for the portfolio of systems within the assigned area
Collaborate with matrix organization to optimize Equipment Verification/Validation/Change Control implementation
Requirements:
Provide or arrange for development of complete verification documentation in accordance with Quality Standards and cGMP requirements for assigned projects
Raise and Implement system change controls as required
Develop and implement changes required to resolve deviations/ non conformances effectively
Participate in design review for new/ modified utility systems
Participate in construction system mechanical completion walkdowns
Author and perform execution of Verification Testing (Qualification) Protocols (VTPs) in field
Assist with execution of temperature mapping of equipment
Assist with pre and post study calibration verifications
Effectively interact with leadership and partner with Engineering Verification, Engineering Project Management, Automation, Maintenance, Operations, and Quality stakeholders to establish priorities and define verification documentation and testing requirements for the portfolio of systems within the assigned area
Collaborate with matrix organization to optimize Equipment Verification/Validation/Change Control implementation
Requirements:
Education: Minimum of a Bachelor of Science (BS) Degree in Engineering or Related Discipline from a fully accredited institution
Experience: Minimum of 4 years of engineering and/or project management experience in Clean (Qualified) & Black (Non-Qualified) utility verifications plus facility systems qualifications
Communication Skills:
Experience: Minimum of 4 years of engineering and/or project management experience in Clean (Qualified) & Black (Non-Qualified) utility verifications plus facility systems qualifications
Communication Skills:
Excellent oral and written communication skills, including presentations
Experienced in a pharmaceutical / FDA-regulated manufacturing environment
Working knowledge of cGMP and facility/equipment validation requirements
Ability to write clearly, concisely, and persuasively in a professional environment
Must be able to write and develop / revise strategy and lifecycle documents
Execution will not occur at start; however, experience in execution of equipment verification is necessary for future phases
Experienced in a pharmaceutical / FDA-regulated manufacturing environment
Working knowledge of cGMP and facility/equipment validation requirements
Ability to write clearly, concisely, and persuasively in a professional environment
Must be able to write and develop / revise strategy and lifecycle documents
Execution will not occur at start; however, experience in execution of equipment verification is necessary for future phases
Himanshu Goswami
Sr. IT Technical Recruiter
Stellent IT Phone:
Email: Himanshu.goswami
Gtalk: Himanshu.goswamiom
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