U.S. Pharmacopeial Convention Jobs

Job Information

The U.S. Pharmacopeial Convention (USP) (Associate) Manufacturing Engineer in Frederick, Maryland

(Associate) Manufacturing Engineer

Tracking Code

1506-679

Job Description

This is a key, hands-on, non-supervisory position in the Reference Standards Production (RSP) group, responsible for continuous process improvement and the day-to-day support of production equipment and automated systems used to produce USP’s reference standards in the Frederick location. The incumbent is required to perform preventive and corrective maintenance on various systems to keep them operational, utilizing scientific, computing, engineering, and other skills to continuously monitor and improve the production & laboratory equipment systems. The engineer resolves technical problems related to production equipment, analytical instrumentation and software to ensure the calibration, qualification, and performance is suitable for use. Training of technicians on proper use, maintenance and care of the equipment is an integral part of the job.

This position has a key role in maintaining USP’s culture of safety by accurate and careful performance of their required tasks. The incumbent is expected to serve as an effective member of a team working cohesively with RS Production, Quality, and Scientific staff assisting with the production and quality control of USP’s reference standards.

This position will be located at the Frederick Facility.

Roles and Responsibilities

  • Plans and analyzes layout of equipment, workflow, and resource utilization to improve production processes, maximize efficiency, and ensure compliance with approved production methods and quality standards. Provides critical analysis of equipment safety & performance, tests, and troubleshoots equipment, and documents deviations and procedures with the goal of improving operations.

  • Develops ideas for improvement and recommends revisions or enhancements to schedules, human and monetary resource allocations, and production requirements. Assists in capacity and annual budget planning.

  • Researches, evaluates, and recommends the purchase of equipment and software. Initiates capital purchase requests, including bid solicitation and discount negotiation, as applicable. Installs equipment and software and maintains an up-to-date inventory. Works with Validation staff to ensure that all equipment, facilities and equipment monitoring systems are properly installed, qualified, and calibrated for RSP production needs and functions in accordance with ISO guidelines (9001 and 17025). Responsible for the preventive and corrective maintenance, calibrations, repairs, and changeovers of equipment.

  • Works with Facilities department to ensure that production facilities are properly functional, required utilities are available, and that proper environmental conditions are maintained in accordance with RSP requirements.

  • Writes and revises Standard Operating Procedures (SOPs) for equipment operation. Writes issue reports for equipment and facilities related deviations and CAPAs. Provides initial and ongoing equipment operation training to production staff.

  • Works with IT to ensure the functionality of all software systems in conjunction with the instrumentation and any other software pertinent to the handling of laboratory and production data. May serve as primary or back-up role as local software administrator.

  • Manages Incoming Component Inspection program which includes inspecting incoming components per approved sampling plans, reconciling inventory quantities, investigating component defects, and providing engineering analysis of new components.

  • Must also be able to facilitate occasional projects not possible during normal business hours due to vendor necessity or customer impact (e.g. ability to be on call for any critical system issues).

  • Performs other related duties as assigned

Basic Qualifications

  • B.S.in Mechanical, Electrical, Packaging or Industrial Engineering or related Engineering field, or equivalent training & working experience.

  • High level of proficiency with manufacturing systems, automation, and office technologies.

  • Work requires passing a pulmonary function test and the use of personal protective equipment (PPE).

Associate Manufacturing Engineer (in addition to above)

  • At least three (3) years of relevant experience, with a minimum of two (2) years within a manufacturing/ production environment.

Manufacturing Engineer (in addition to above)

  • At least five (5) years of relevant experience, with a minimum of three (3) years directly supporting a manufacturing/production environment, and with demonstrated process improvement success.

Preferred Qualifications

  • Experience with quality system regulations, design controls and ISO standards.

  • Anticipate failure, troubleshoot and repair hydraulic, pneumatic, mechanical and electrical equipment, conveyors, PLCs, vision systems and computer controlled devices.

  • Familiarity or prior experience with pharmaceutical manufacturing or biotech industry a plus.

  • Excellent written and verbal communication skills required, along with strong analytical skills and ability to work on both basic and strategic processes.

  • Able to operate independently, yet understands when to escalate issues and how to establish effective working relationships in a team setting to accomplish department goals.

  • Highly organized and exceptional attention to detail, with demonstrated effective time management and prioritization skills.

  • Certifications or training in Six Sigma, Lean methodologies, or other continuous improvement tools a plus.

  • Experience with computerized maintenance management system (CMMS) for tracking work orders, calibrations and spare parts a plus.

  • Must also be able to facilitate occasional projects not possible during normal business hours due to vendor necessity or customer impact (e.g. ability to be on call for any critical system issues).

  • Ability to lift 20 lbs. and may be required to access spaces which require bending or kneeling positions.

  • Working knowledge of relevant computer applications (MS Office suite, Oracle).

Supervisory Responsibilities

None

Job Location

Frederick, Maryland, United States

Position Type

Full-Time/Regular

Job Category Laboratories

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