Senior Manufacturing Engineer

Job Locations

US-OH-Cincinnati

Company

Meridian Bioscience, Inc.

Department

Operations

of Openings

About Meridian

Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. We are dedicated to developing and delivering better solutions that give answers with speed, accuracy and simplicity that are redefining the possibilities of life from discovery to diagnosis. We are looking for talented and passionate individuals that help drive our vision. Our innovative culture will allow interested candidates to discover and create, through collaboration, cutting edge solutions to tough problems.

Job Summary

The Senior Process Engineer is responsible for equipment/automation/process design, fabrication, and troubleshooting. Primary representative during vendor management, development, and approval of User Requirement Specifications (URS) of major manufacturing equipment identification and procurement. Perform periodic review of manufacturing equipment with Production and Facility personnel to identify areas for obtaining improved operational efficiencies.

Key Duties

Process Management

Owner of periodic reviews of maintenance and validation activities for major production equipment to identify process improvement and efficiency projects. Includes review and data analytics of complex manufacturing systems.

Lead cross-functional teams to ensure production equipment maintains design requirements and meets operational goals and user needs.

Manages the URS, FAT, and SAT process for new production equipment.

Equipment procurement

Mentors and assists other Engineers in the identification and procurement of manufacturing equipment and automation

Ensures completion of design documentation (URS, FAT, and SAT) for new equipment procurement according to internal procedures and in accordance with industry standards (GAMP, ASTM E2500)

Identifies, qualifies, and works with equipment vendors.

Leads cross functional procurement team.

Performs project management activities to ensure projects are on time, within budget, and successful.

Validation

Supports validation engineers for equipment qualification.

Author, obtain appropriate approvals, and perform validation studies.

Maintenance

Support maintenance staff to service equipment as needed.

Supplies troubleshooting support to help identify the causes of product/production related problems.

Design and implement process improvements and corrective actions.

Process Design

Designs full-scale manufacturing equipment and/or processes for new products from R&D

General

Read, understand, and comply with Good Manufacturing Practices and Standard Operating Procedures and accurately complete all required documentation per SOP requirements.

Perform all duties in accordance with safety rules as well as appropriate industry and regulatory guidelines.

Communicates clearly and effectively with department peers, manufacturing personnel, as well as supervisors, managers, and directors.

Assist and train employees on proper equipment operation.

Write and/or modify manufacturing and equipment related procedures as needed.

Update and maintain facility maps.

Other duties as assigned.

Qualifications

A minimum of four years of experience in equipment procurement and/or process design.

Previous experience in and FDA regulated production environment is desirable

Must possess a working knowledge of the Metric System

Advanced computer skills required (Word, Excel, CAD knowledge, PLC Database).

Proficient in CAD. Solidworks and AutoC

Meridian Bioscience, Inc.

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