Oversees the Business Unit performance on key manufacturing processes and equipment. Assures Key Performance Indicators (KPI) are improved through a structured and scientific approach.
Provides technical coaching and guidance to other BU members. Leads or provides technical support to other Business Units or plant wide initiatives.
Designing and programming of Process Automation Improvement systems.
Programming & troubleshooting PLC’s and SCADA systems
Providing guidance and support to Control Technicians and Process Improver Controls engineers
Leading technical solutions that increase utilization and reduce costs
Developing Visual basic C ++ applications for Process Improvement
Minimizing service interruptions and avoid unplanned downtime on manufacturing lines
Developing process and regulatory documentation for automation systems
Performing and documenting engineering studies
Improving accuracy of Automation System requirements and specifications for the development of SCADA and other systems.
Reviewing / Modifying Standard Operating Procedures for Engineering Controls.
Assuring compliance with Laws & Regulations.
Submitting documentation for safety compliance, new equipment calibrations, calibration extensions and preventive maintenance.
Systems & equipment PM’s SOP’s revisions and / or improvements.
Evaluating needs for infrastructure and start-ups.
Early Involvement in Transference Effort with Technical Innovations (ROI)
Early Involvement in LS / Optimization Efforts with Technical Innovations
Assuring Readiness of Manufacturing Requirements for the Optimization Efforts
Assuring Compliance with Laws & Regulations
Vacations & Overtime Administration for Non- Exempt
Generate Purchase Requisitions
KNOWLEDGE, SKILLS AND ABILITIES
Knowledge of FDA current GMP / QSR regulation
Excellent oral and written communication skills in both English and Spanish languages
Teamwork and service oriented
Computer literate (PowerPoint, Word, Excel)
Willing to travel
Generally works in a closed environment, in office conditions, with moderate level of noise and controllable changes of temperature
Needs to stand, walk and may be seated for a long period of time
Uses hands to feel, finger or handle and reach.
Performs light physical effort with little exposure to adverse conditions
Could be required to travel.
Works with a personal computer and programs to prepare documents or reports
Applies communication skills (advance reading, writing, and technical skills) and mathematical concepts knowledge to perform work and coordinate with others
Needs to have high analytical capacity and level of professionalism and judgement to resolve problems
Incumbent could works near moving mechanical parts
Five to ten years of experience with similar responsibilities in a regulated industry (medical devices / pharmaceutical highly desirable).
Bachelor degree in Engineering, (Industrial, Chemical, Mechanical, Electrical and / or Computer). Master, preferred. Engineering-In-Training (EIT) licensed.
Affirmative Action / Equal Opportunity Employer. Minority / Female / Disability / Veteran