Lab Equipment Engineer

Lab Equipment Engineer

Pay Rate: $44.00 /hr – $66.300/ hr

Duration: 5 months Contract to Permanent (Full Time)

Qualifications:

Education, experience, certification and licensures

Required

• Bachelor’s degree in Chemistry or related field

• Minimum 3-5 years’ experience with QC lab work experience with industry experience in Pharmaceutical

Preferred

• Capital project experience

• Computer Systems Validation experience

Knowledge, skills and abilities

1. Excellent oral and written communication skills

2. Ability to work independently or as part of a team

3. Solid understanding of cGMP’s and GLP and familiarity with 21 CFR Part 11

4. Meets commitments on time and practices time-management skills)

5. Seeks to identify continuous improvement needs

6. 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 Responsibilities

This position does not have supervisory responsibilities.

Essential job duties

1. Manage capital projects related to instrumentation and direct department activities to achieve the goals of the project

2. Prepare calibration, Preventive Maintenance and operational SOP whenever required under guidance of QC Lab Manager / Director

3. Prepare IQ, OQ, PQ protocol for analytical instruments under guidance of QC Lab Manager / Director

4. 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 CAPAs

5. Draft, review and approve Standard Operating Procedures

6. Maintain the instrument quality program which includes IQ, OQ, PQ, Preventive maintenance and Calibration program of Analytical instruments

7. Troubleshooting and Repairs of analytical Instruments

8. Maintain work orders for Instruments repair

9. Instrument asset management and life cycle

10. Inform QC management for downtime of any lab instrument

11. 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 activity

12. Coordinate with outside lab instrument manufacturer and service providers for repairs. Get the quotes for repairs, calibrations, qualifications, and preventive maintenance including parts & labor

13. 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 / equipment

14. Recommend and implement methods to increase the quality of products and/or services

15. Participate in self-development activities and training of others

16. Exhibit safety awareness and safe work practices. Protect employees and visitors by maintaining a safe and clean working environment

17. Other duties and responsibilities as assigned.