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Validation Specialist

Company: Unassigned/Prospective Account
Location: Caldwell
Posted on: September 16, 2021

Job Description:

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 Program.

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 Qualifications.

11. Assesses regulatory impact of deviations, changes to equipment and batch records, materials, and calibrations from validation perspective.

12. Analyzes data and works with Project manager to solve technical problems.

13. Assumes supervisory role in absence of supervisor (for Sr. Level)

14. Additional duties and tasks assigned at the discretion of Quality Management.



Bachelors degree in science

Minimum of 3 years in a Pharmaceutical Field or 7 years for Sr. Level

Excellent reading, writing, and verbal

Above average mathematic skills

Proficient in word, excel and power point

Experience in cleaning, manufacturing processes, equipment, and facilities validations.

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 reports.

Familiarity with Change Control Processes.

Keywords: Unassigned/Prospective Account, New York , Validation Specialist, Other , Caldwell, New York

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