The Validation Technician will assist laboratory personnel with product, Maintenance and equipment calibration issues according to FDA, cGMP and Boston Analytical’s Standard Operating Procedures.
PRIMARY DUTIES AND RESPONSIBILITIES
- Maintenance, calibration and necessary repair of all equipment in the Analytical and the Microbiology Laboratories.
- Monitors and maintains water system.
- On-call Monitoring of stability chambers and controlled rooms.
- Calibration of equipment and instrumentation required for tests, including mechanical and chemical tests.
- IQ, OQ and PQ of equipment following specific protocols generated by the group management.
- Installation, maintenance and calibration of stability chambers.
- Assists Chemists and other company personnel on an as needed basis.
- Follows all safety rules and regulations.
- Follows all cGMP rules and regulations.
- Ensures all work performed strictly adheres to cGMP, Company, client and Pharmacopeial methodologies.
- Assist in proper management of hazardous waste and compliance with DES hazardous waste rules.
REQUIREMENTS & QUALIFICATIONS
A high school diploma or GED is required, or an AS degree in a scientific discipline preferred. A Metrology Technician should be willing to attend technical training classes to enhance skills or correct identified deficiencies. Requires the ability to lift and/or move up to 50 lbs.
MINIMUM SKILLS REQUIREMENTS
- Must have the ability and skill to perform the detailed job requirements noted above competently, safely and proficiently.
- Self-starting motivated person who possesses good interpersonal skills and who is able to effectively interact with all departments with the Company.
- Must have good organizational and verbal communication skills.
- Basic computer skills required. Experience with cGMP is preferred.
- Must be a team player with integrity and concern for the quality of Company products, services and staff members.