Lab Equipment Engineer
Lab Equipment Engineer Pay Rate: $44.00 /hr – $66.300/ hrDuration: 5 months Contract to Permanent (Full Time) Qualifications:Education, experience, certification and licensuresRequired• Bachelor’s degree in Chemistry or related field• Minimum 3-5 years’ experience with QC lab work experience with industry experience in PharmaceuticalPreferred• Capital project experience• Computer Systems Validation experienceKnowledge, skills and abilities1. Excellent oral and written communication skills2. Ability to work independently or as part of a team3. Solid understanding of cGMP’s and GLP and familiarity with 21 CFR Part 114. Meets commitments on time and practices time-management skills)5. Seeks to identify continuous improvement needs6. Experience with Perkin Elmer HPLC/Totalchrom, Waters HPLC/UPLC/Empower a plus.Responsibilities:The Lab Equipent Engineer is responsible for maintenance and safekeeping of all equipment, and other instruments used by the Quality Control Labs. This position also supports activities to complete ongoing in-house calibrations, qualifications and performance qualifications with coordination with approved vendors. Maintenance of all logs, protocols and documents per FDA GMP guidance and control. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.Supervisory ResponsibilitiesThis position does not have supervisory responsibilities.Essential job duties1. Manage capital projects related to instrumentation and direct department activities to achieve the goals of the project2. Prepare calibration, Preventive Maintenance and operational SOP whenever required under guidance of QC Lab Manager / Director3. Prepare IQ, OQ, PQ protocol for analytical instruments under guidance of QC Lab Manager / Director4. Coordinate with QA to complete CR related to analytical instruments. Assist all departments in investigations of instrument related issues including completion of assigned deviations and CAPAs5. Draft, review and approve Standard Operating Procedures6. Maintain the instrument quality program which includes IQ, OQ, PQ, Preventive maintenance and Calibration program of Analytical instruments7. Troubleshooting and Repairs of analytical Instruments8. Maintain work orders for Instruments repair9. Instrument asset management and life cycle10. Inform QC management for downtime of any lab instrument11. Manage scheduling of all the instrument and equipment calibration and preventative maintenance programs. Act as point of contact for all outside vendors activities and troubleshooting activity12. Coordinate with outside lab instrument manufacturer and service providers for repairs. Get the quotes for repairs, calibrations, qualifications, and preventive maintenance including parts & labor13. Ensure that the data generated by the chemists are accurate and precise; laboratory operation and activities are in compliance with cGMP. Verify / Review the logbooks for operation of instrument / equipment14. Recommend and implement methods to increase the quality of products and/or services15. Participate in self-development activities and training of others16. Exhibit safety awareness and safe work practices. Protect employees and visitors by maintaining a safe and clean working environment17. Other duties and responsibilities as assigned.