Background in smart manufacturing technologies and key business systems (e.g. AR/VR Technology, MES, ERP, SCADA, Systech, Serialization).
Build up knowledge on new processes, systems and technologies in an efficient way.
Experience in either a GMP environment or ISO experience
Red Flags:
Candidates without Manufacturing, Engineering, or Computer Science experience.
Job Hopping
WHAT YOU WILL DO
In this role you will lead various smart manufacturing technologies and computerized systems improvement initiatives within manufacturing to support the end user on the shop floor as well as support the business with data analytics and reporting. You will oversee critical processes, provide technical leadership, and be responsible for designing, implementation, and validation of these systems and digital technologies. This role is critical for our success and key in supporting operations towards a more digital future.
Responsibilities:
Provides technical support, project management, and troubleshooting assistance of various smart manufacturing technology and computerized systems within the manufacturing area (e.g. AR/VR Technology, MES, ERP, SCADA, Systech, Serialization).
Support the site in the project approvals, prioritization, and manage the roll-out and implementation of smart manufacturing technology concept initiatives to support the manufacturing area.
Support the business with the implementation of data analytics, reporting and provide insight in business critical KPIs and OEE (e.g. KPI tools, OEE, Spotfire).
Support Ohio manufacturing team during troubleshooting for key computerized systems and assist during problem solving.
Act as manufacturing business representative in cross-functional meetings and support all levels of the organization to drive digital manufacturing projects.
First line Subject Matter Expert (SME) for smart manufacturing technology, computerized systems, and MES and ERP.
Assist in global harmonization strategic activities for digital manufacturing which include but not limited to design, improvements, system configuration, validation, and investigations.
Support key business system lifecycle management activities and represent team during software or system upgrades.
Generate, and review documents (SOPs, FORMs, Deviations, CAPA, CC, etc.) associated and owned by digital manufacturing team.
Work with team to ensure training on new or revised digital manufacturing processes is effective and completed for end-users (Operators/Supervisors/Technical/QA/Support Staff).
Uses the latest data analysis tools and methodologies to solve systematic problems and improve process efficiencies to maintain production schedule adherence.
WHAT WE EXPECT OF YOU
We are all different, yet we all use our unique contributions to serve patients. The experienced professional we seek is a collaborative partner with these qualifications.
Basic Qualifications:
Master's Degree within Manufacturing, Engineering, or Computer Science experience.
Or
Bachelor's Degree and 6 months of Manufacturing, Engineering or Computer Science experience.
Or
Associate's Degree and 2 years of Manufacturing, Engineering or Computer Science experience.
Or
High School/GED and 4 years of Manufacturing, Engineering or Computer Science experience.
Preferred Qualifications:
Educational Background or experience in Science, Pharmaceuticals, Biotechnology, Digital Technology, and/or Engineering.
Experience with data analytics, process performance and reporting tools (e.g. KPIs, OEE, Spotfire).
Experience with design, configuration, qualification/validation in smart manufacturing and computerized systems and system integration supporting manufacturing and the end user e.g. MES, ERP, SCADA, Systech, Serialization.
Experience in a GMP environment and background in smart manufacturing technologies and computerized systems and comprehensive understanding of the Manufacturing process with the ability to translate to an Electronic Batch Record.
Analytical fact-based problem solver and strong troubleshooting skills on process, equipment, smart technology, and computerized systems.
Ability to maintain an environment and culture of operation excellence, continuous improvement, and lean manufacturing (Kaizen process improvements).
The ability/experience working in fast paced manufacturing environment where issues must be assessed, understood, and resolved immediately to be able adapt quickly to the demands of commercial manufacturing operations.
Experience in deviations, investigations, root cause analysis, CAPA's and change controls.
Pro-active, result oriented, and ability to prioritize work to meet timelines.
Good documentation practices and skills including technical writing
Good communication skills to all levels of the organization.
Pay range is $27 - $32 per hour with full benefits available, including paid time off, medical/dental/vision/life insurance, 401K, parental leave, and more. Our compensation reflects the cost of labor across several US geographic markets. Pay is based on several factors including market location and may vary depending on job-related knowledge, skills, and experience.
THE PROMISES WE MAKE:
At Crystal Equation, we empower people and advance technology initiatives by building trust. Your recruiter will prep you for the interview, obtain feedback, guide you through any necessary paperwork and provide everything you need for a successful start. We will serve to empower you along the way and provide the path for your professional journey.