Senior Process Improver (Manufacturing)
JOB TITLE: Sr. Process Improver
DEPARTMENT: One Day
Continuously improves the performance of existing manufacturing processes and equipment through a structured approach.
· Coordinating production improvements implementation.
· Creating troubleshooting guidelines and/or applicable SOPs and equipment maintenance and repair.
· Identifying possible causes of variation/ failure/ under performance for Manufacturing.
· Document diagnostics, solution method and impact in troubleshooting for Manufacturing.
· Measuring Process KPIs for improvement.
· Analyzing through a structured approach to identify root causes.
· Improving Process KPIs performance.
· Developing control mechanism to ensure Process KPIs consistency.
· Designing and Coordinating Engineering Tests/ Q's.
· Executing Engineering Tests/ Q's.
· Documenting and Reporting Results of Engineering Tests/ Q's.
· Assuring Readiness of Manufacturing Requirements for the Product Transfer.
· Receiving and Implementing Product and Equipment Transfer.
· Observing, Analyzing, Documenting & Recommending the Start-up of Product Transfer.
· Assuring Operator and BU's resources have the Skills and knowledge coming from change due to Optimizations.
· Implementation of Optimization Efforts.
· Defining manufacturing equipment maintenance requirements.
· Developing TPM/ PM/ PDM procedures for manufacturing Equipment.
· Verifying TPM/ PM/ PDM tasks effectiveness in manufacturing.
· Ensuring correct resources are acting upon situation for Equipment Repair.
· Correcting troubles in Manufacturing under performance situation using troubleshooting guidelines
and/or applicable SOPs.
· Measuring Equipment Efficiency.
· Identifying Opportunities for Improvements in Equipment Performance.
· Implementing Equipment Upgrades and Optimization Changes.
· Writing Validation Documentation and Test Protocols.
· Documenting all Equipment Changes.
· Assuring Compliance with Laws & Regulations.
· Generation of Purchases Requisition.
· Submitting Scope and Approve Projects.
· Submitting Documentation for Safety Compliance, New Equipment Calibrations, Calibration extensions and Preventive Maintenance.
· Systems & Equipment PM's SOP's Revisions/ Improvements.
· Evaluating Needs for Infrastructure Projects and Start-ups.
· Submitting MSDS as Required.
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.
· Effective leadership.
· Computer literate (PowerPoint, Word, Excel).
· Willing to travel.
· Excellent interpersonal skills.
· Highly motivated, self-starter, and responsible person.
· Complies with the Quality System Regulation (QSR).
· Executes job responsibilities as established in the Standard Operating Procedures (SOP).
· Follows the documentation procedures.
· Looks for ways to improve and promote quality.
· Applies feedback to improve and promote quality.
· Complies with Safety and Occupational Health Policy and procedures.
· Complies with Hazardous Communication program.
· Notifies immediately all accidents or incidents occurred in work area.
· Complies with the usage, inspection and maintenance of the personal protective equipment required, if applicable.
· Promotes and maintains a safe working area and notifies any condition he/she may think might cause an accident.
· Participates in the activities of the Safety and Occupational Health Program as requested.
· Bachelor degree in Engineering (Industrial, Chemical, Mechanical, Electrical).
· Master, preferred.
· Engineering-In-Training (EIT) licensed.
Six to ten years of experience with similar responsibilities in a regulated industry (medical devices/pharmaceutical highly desirable).