Senior Manufacturing Engineer

About the Company

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, redefining the possibilities of life from discovery to diagnosis. Our innovative culture allows interested candidates to discover and create through collaboration, cutting edge solutions to tough problems.

Responsibilities

• Owner of periodic reviews of maintenance and validation activities for major production equipment to identify process improvement and efficiency projects, including 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.
• Manage the User Requirement Specifications (URS), Factory Acceptance Testing (FAT), and Site Acceptance Testing (SAT) process for new production equipment.
• Mentor and assist other engineers in the identification and procurement of manufacturing equipment and automation.
• Ensure completion of design documentation (URS, FAT, and SAT) for new equipment procurement according to internal procedures and industry standards (GAMP, ASTM E2500).
• Identify, qualify, and work with equipment vendors; lead cross-functional procurement teams.
• Perform project management activities to ensure projects are on time, within budget, and successful.
• Support validation engineers for equipment qualification; author, obtain approvals, and perform validation studies.
• Support maintenance staff to service equipment as needed; provide troubleshooting support to identify causes of product/production-related problems.
• Design and implement process improvements and corrective actions.
• Design full-scale manufacturing equipment and/or processes for new products from R&D.
• Read, understand, and comply with Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs); accurately complete all required documentation per SOP requirements.
• Perform all duties in accordance with safety rules, industry, and regulatory guidelines.
• Communicate clearly and effectively with department peers, manufacturing personnel, 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.
• Perform other duties as assigned.

Qualifications

• A minimum of four years of experience in equipment procurement and/or process design.
• Previous experience in an FDA-regulated production environment is desirable.
• Working knowledge of the Metric System.
• Advanced computer skills (Word, Excel, CAD knowledge, PLC Database); proficient in CAD (SolidWorks and AutoCAD experience preferred).
• Proficient in programming, specifically industrial control systems and ladder logic (RSLogix 5000 preferred).
• Thorough knowledge of electrical control systems.
• Proficient mechanical skills using diagnostic tools to test, troubleshoot, and repair complex equipment.
• Ability to read/understand blueprints, schematics, wiring diagrams, and other specialized documentation.
• Ability to read, understand, and follow all company Standard Operating Procedures (SOPs) and guidelines; adhere to safety SOPs and report potential safety hazards.
• Strong math skills.
• Self-starter, detail-oriented, organized, and able to perform under pressure in a fast-paced environment with minimal supervision.
• Excellent interpersonal, organizational, written, and oral communication skills.
• Ability to maintain regular attendance and punctuality requirements.
• Must be able to work overtime and weekends to support production efforts as needed.
• Ability to work independently as well as collaboratively in a team setting with peers in a cross-functional environment.
• Excellent analytical, problem-solving, and troubleshooting skills.