Validation Engineer
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Job Location:
Lake Bluff, IL - USA
Monthly Salary:
Not Disclosed
Posted on:
7 hours ago
Vacancies:
1 Vacancy
Job Summary
Validation Engineer
Fulltime
Lake Bluff Illinois
Job Description & Skill Requirement:
Apply knowledge of cGXPs relevant SOP curriculum routine project procedures project management and other trainings as appropriate.
Serve as project lead with projects of intermediate scope and cross-functional teams.
Apply knowledge of FDA21CFR Part11 GAMP5 and data integrity to analytical instrument validation.
Develop the following of FDA 21CFR part11 GAMP5 and Data integrity to analytical instrument validation
Develop the following validation deliverables - Risk management Reports change controls regulatory assessments 21CFR Part11 Assessments validation plans qualification reports and other related documents required per SOP
Responsible for the management and archiving of approved package documents
Mentors and provides leadership to junior team members
Handle routine tasks timely and accurately.
Apply knowledge of cGXPs relevant SOP curriculum routine project procedures project management and other trainings as appropriate.
Serve as project lead with projects of intermediate scope and cross-functional teams.
Apply knowledge of FDA21CFR Part11 GAMP5 and data integrity to analytical instrument validation.
Develop the following of FDA 21CFR part11 GAMP5 and Data integrity to analytical instrument validation
Develop the following validation deliverables - Risk management Reports change controls regulatory assessments 21CFR Part11 Assessments validation plans qualification reports and other related documents required per SOP
Responsible for the management and archiving of approved package documents
Mentors and provides leadership to junior team members
Handle routine tasks timely and accurately.
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
