What will you do?
The individual will support the Operations department with continuous improvement projects, machine troubleshooting, and onboarding of assets and new technology. Establish a solid focus on long-term continuous improvement activities through interaction with the entire Engineering and Operations Staff. Evaluate process improvements to reduce cost, improve efficiency, and improvement quality. Assist with advanced machine troubleshooting. Compliantly perform all tasks and required documentation in a GMP regulated environment.
How will you get here?
A four-year, Bachelor of Science degree from an accredited college and/or university in Packaging, Electrical, Mechanical or Industrial Engineering or related discipline. Engineering experience in relevant GMP, pharmaceutical or food industry: Requires 3+ years, 5-10 years preferred.
- Applies Good Manufacturing Principles in all areas of responsibility.
- Demonstrates and promotes the company vision of the 4 I’s: Integrity, Intensity, Innovation and involvement.
- Conducts all activities in a safe and efficient manner.
- Establishes a solid focus on long-term continuous improvement activities through interaction with the entire Engineering and Operations Staff.
- Recommends and implements methods for improving worker efficiency, reducing cost, and reducing waste of materials and utilities such as restructuring job duties, reorganizing workflow, relocating workstations and equipment, and purchase of new equipment / technology.
- Manages and reports out on multiple project engineering driven assignments and the associated project schedules, from start to finish with sound project management methodologies.
- Collaborates with Production to modify workflow barriers and arrangements to increase throughput.
- Evaluates and drives engineering project initiatives to reduce setup time, increase machine speeds, reduce labor hours, reduce reject rates, and improve quality.
- Provides technical specifications and supporting documentation for Engineering project designs, and machine upgrades.
- Completes deviation investigations, change controls and corrective/preventative actions.
- Reviews and approves Engineering and Validation documents.
- Assists in developing departmental strategies.
- Assist in project coordination and execution.
- Other duties may be assigned to meet business needs.
Knowledge, Skills, Abilities
- Well versed in process improvement, industrial design applications that pertain to a job shop environment.
- Experience in food or pharmaceutical packaging experience required. Experience with blister machines, bottling, carding, labeling, and syringe assembly preferred.
- Must be results oriented and comfortable training and coaching others.
- Must have a detailed understanding of change management throughout the asset lifecycle.
- Must have strong analytical skills in Lean Manufacturing, Six Sigma, PPI and Single-Minute Exchange of Dies (SMED) to enhance quality, reduce rejects, and streamline processes.
- Must have a baseline level of mechanical aptitude and experience troubleshooting packaging machinery. Experience with failure analysis and reliability engineering preferred.
- Must be able to multitask and respond to shifting priorities.
- Must have strong technical writing skills with experience writing Requirement Specifications (Design, Functional, User), FMEAs, FAT/SAT/Commissioning Protocols, SOPs and Work Instructions.
- Must be proficient with computer software (MS Office) and have expertise with spreadsheets.
- Must have good communication skills, both written and verbal, and the ability to communicate with non-engineering personnel in layperson’s terms.
- Mastery of skills required to read, understand, and adhere to the SOPs and policies of a GMP environment.
- Exert up to 10 lbs. of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
- Prolonged sitting but may involve walking or standing for brief periods of time.
- May need to stoop, reach, or bend.