Company: Unassigned/Prospective Account
Posted on: September 16, 2021
1. Basic Office Setting - Exposure to Computer Monitor
2. Physical Requirements - Not Applicable
3. Business Travel Not Required
4. Business Dress
5. Supports/Drives Process Validation Program (Process and
Equipment) including Continued Process Verification (Stages 2 and 3
of 2011 FDA Guidance on Process Validation).
6. Supports/Drives Cleaning Validation and Verification
7. Interacts directly with customer on deviations and cleaning and
process validation strategy for assigned projects.
8. Reviews and approves batch records.
9. Reviews and validates Electronic Spreadsheets.
10. Supports Equipment Installation and Operational
11. Assesses regulatory impact of deviations, changes to equipment
and batch records, materials, and calibrations from validation
12. Analyzes data and works with Project manager to solve technical
13. Assumes supervisory role in absence of supervisor (for Sr.
14. Additional duties and tasks assigned at the discretion of
Bachelors degree in science
Minimum of 3 years in a Pharmaceutical Field or 7 years for Sr.
Excellent reading, writing, and verbal
Above average mathematic skills
Proficient in word, excel and power point
Experience in cleaning, manufacturing processes, equipment, and
Knowledge of pharmaceutical process and equipment
Knowledge of validation concepts and current cGMP (21 CFR Parts 210
& 21, 820 & Part 11). Extensive experience with Data Integrity
Assessments and Computerized System Validations (for Sr. Level)
Batch records knowledge and data review experience
Demonstrated experience in writing and reviewing validation
Familiarity with Change Control Processes.
Keywords: Unassigned/Prospective Account, New York , Validation Specialist, Other , Caldwell, New York
Didn't find what you're looking for? Search again!