Calibration Technician - TechDigital Corporation
Warren, NJ 07059
About the Job
Job Responsibilities:
To support manufacturing and laboratory operations calibration program in a timely manner and take preventive measures to assure proper functioning of operational equipment ensuring compliance with Company standards and regulatory requirements. This position must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function.
1. Verifies and/or calibrates instrumentation as required per current CMMS System
2. Documents Calibration process using current CMMS.
3. Revises calibration sheets to ensure proper documentation, calculation and process completion.
4. Modifies or update CMMS documentation as required
5. Repairs instruments and equipment as required.
6. Uses several test equipment and tools (e.g. pressure, temperature indicators, etc.)
7. Contacts supplier for quote external calibration of the instrument and standards
8. Performs inventory of the standards in the calibration shop
9. Initiates, participates, and assists in resolution of quality investigations
10. Attends to all mandatory training for GMP's EHS and company Policies
11. Attends to all mandatory meeting as staff.
12. Revises, improves or create calibration procedures based on observation or current experience.
13. Participates actively in special projects as required
14. Troubleshoots manufacturing and utilities equipment
15. Participates and assist validation and qualification process
16. Writes and reviews SOP's for instruments and controls.
17. Prepares reports and keeps records on calibration inspection, testing, and repair.
18. Ensure low cost of the calibration department (Reducing overtime, implementing new ideas)
19. Plans, justify and implement cost reduction small projects.
20. Escorts vendor to perform equipment calibration.
21.Writes and supports deviations and investigations that result from calibration, performance verification or maintenance activities, along with developing and supporting the implementation of corrective and preventive actions.
22.Supports the development, revision, and review of written procedures for calibration, preventive maintenance, and performance verification of equipment.
23.Executes requalification on Controlled Temperature Units (ex. Refrigerators, -20°C/-80°C Freezers, Incubators, Cryotanks, Cryopods, and Walk-In Cold Rooms)
24.Reviews and approves vendor executed calibration, maintenance, repair, and performance verification records for accuracy, completeness, and compliance to Client standards.
Education qualifications:
High school Diploma or Associates or Bachelor's degree
Experience:
3+ years of lab experience preferred in pharma or medical device industry or manufacturing
To support manufacturing and laboratory operations calibration program in a timely manner and take preventive measures to assure proper functioning of operational equipment ensuring compliance with Company standards and regulatory requirements. This position must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function.
1. Verifies and/or calibrates instrumentation as required per current CMMS System
2. Documents Calibration process using current CMMS.
3. Revises calibration sheets to ensure proper documentation, calculation and process completion.
4. Modifies or update CMMS documentation as required
5. Repairs instruments and equipment as required.
6. Uses several test equipment and tools (e.g. pressure, temperature indicators, etc.)
7. Contacts supplier for quote external calibration of the instrument and standards
8. Performs inventory of the standards in the calibration shop
9. Initiates, participates, and assists in resolution of quality investigations
10. Attends to all mandatory training for GMP's EHS and company Policies
11. Attends to all mandatory meeting as staff.
12. Revises, improves or create calibration procedures based on observation or current experience.
13. Participates actively in special projects as required
14. Troubleshoots manufacturing and utilities equipment
15. Participates and assist validation and qualification process
16. Writes and reviews SOP's for instruments and controls.
17. Prepares reports and keeps records on calibration inspection, testing, and repair.
18. Ensure low cost of the calibration department (Reducing overtime, implementing new ideas)
19. Plans, justify and implement cost reduction small projects.
20. Escorts vendor to perform equipment calibration.
21.Writes and supports deviations and investigations that result from calibration, performance verification or maintenance activities, along with developing and supporting the implementation of corrective and preventive actions.
22.Supports the development, revision, and review of written procedures for calibration, preventive maintenance, and performance verification of equipment.
23.Executes requalification on Controlled Temperature Units (ex. Refrigerators, -20°C/-80°C Freezers, Incubators, Cryotanks, Cryopods, and Walk-In Cold Rooms)
24.Reviews and approves vendor executed calibration, maintenance, repair, and performance verification records for accuracy, completeness, and compliance to Client standards.
Education qualifications:
High school Diploma or Associates or Bachelor's degree
Experience:
3+ years of lab experience preferred in pharma or medical device industry or manufacturing
Source : TechDigital Corporation