Equipment Engineer, ECQ
Edison-New Brunswick Metro Area, NJ
1) Operational Activities
a. Executes equipment calibrations, maintenances, repairs, and requalification activities in both laboratory and manufacturing areas.
b. Supervises vendors for Calibration, preventative maintenance, and qualification functions.
c. Reviews and approves vendor executed calibration, maintenance, repair, and qualification records for accuracy, completeness and compliance to company standards.
d. Works closely with and enters data into the site CMMS system.
e. Ensures all calibration, PM, and qualification records are filed appropriately after approval.
f. Writes and supports deviations and investigations that result from qualification failures along with developing and supporting the implementation of corrective and preventative actions.
g. Support the development, revision and review of written procedures for calibration, preventive maintenance and requalification of equipment.
h. Support the development, review and approval of calibration and maintenance plans in site CMMS system.
i. Addresses BEMS equipment alarms and ensures storage equipment maintains the appropriate set points.
j. Supports the execution of equipment qualifications and process improvement studies.
k. Adheres to all policies and procures which govern the ECQ team and the equipment they manage in order to ensure compliance is held to the highest standard.
2) Promotes and provides excellent customer service and support
a. Regularly reviews, prioritizes and promptly responds to customer equipment maintenance, repair and support requests.
b. Provides technical support and guidance on calibration and maintenance issues. Interfaces with customers to ensure expectations are being met.
3) Inventory Management
a. Work with planning group to ensure CMMS system is updated as calibration, maintenance and requalification activities are performed.
4) Regulatory Responsibilities
a. Maintains all required Corporate, Facilities and EHS training as required.
b. Adheres to all safety procedures and hazard communication.
c. May be called upon to act as Subject Matter Expert in both internal and regulatory audits.
REQUIRED COMPETENCIES KNOWLEDGE, SKILLS, AND ABILITIES:
Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices.
Advanced knowledge of pharmaceutical, manufacturing and laboratory systems and equipment.
Experience troubleshooting Beckman Coulter Multisizer 4e
Experience working in a sterile environment
EDUCATION & EXPERIENCE:
BS in Engineering or Science related discipline preferred.
Minimum 5 years experience in GMP laboratory or manufacturing environment / regulated industry required.
Minimum 2-3 years' experience working with and troubleshooting complex laboratory equipment required.
Experience writing and supporting deviations and investigations preferred.
Experience working with CMMS systems, mainly Blue Mountain RAM preferred.