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Job Details

Job Title: Machine Specialist
FLSA Status (if applicable) Nonexempt
Job Family: Manufacturing
Initiation Date: 2/2/2018 1:32:49 PM
Last Updated: 2/2/2018 1:33:01 PM by Gallerane, Laura (236373)
Job Description Code: 605355
JOB SUMMARY The Machine Specialist is responsible for operating and maintaining assigned production equipment to support production needs. This role will act in a leadership capacity in the production areas, working in tangent with the Group Leader and Senior Machine Operator, with a focus on maximizing production, decreasing equipment down time, and reducing scrap. This role will perform daily maintenance tasks on production equipment, component inspections, minor machine repair, and equipment verifications. This role will report directly to the functional area Supervisor, with regular interaction and work assignments coordinated through the Maintenance department. This position must communicate effectively with Mechanics, Leads, Supervisors, Managers and Sr. Management. ESSENTIAL DUTIES
Duties are listed in order of greatest importance. The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.
Enter Responsibilities/Essential Duties • Minimizes equipment downtime and ensures achievement of daily and weekly production goals. • Completes routine maintenance and upkeep of equipment, including basic troubleshooting, routine and standard repairs that are authorized, and daily and weekly preventive maintenance tasks. • Locates sources of problems by observing mechanical devices in operation; soliciting information from line operators and other production associates, and listening for problems. Repairs problems as authorized. • Verifies effectiveness of repairs, improvements and ensures product produced meets specification. • Performs and documents all assigned preventive maintenance in accordance with the local policies and procedures as dictated by the Maintenance Management team. • Owns daily cleaning and daily preventative maintenance tasks. Ensures production equipment is wiped down using proper techniques and personal protection equipment to ensure effective and efficient operation. Trains operators on proper cleaning procedures and techniques for assigned manufacturing equipment. • Works closely with the maintenance and engineering team to complete a variety of activities, including but not limited to: developing user instructions and job aids, implementing process changes, root cause evaluations, corrective actions, qualifications, tests, protocols, validation and other department projects. • Responds to machines faults by observing potential fault causes, reacting problem fault, and recovering machine if fault occurs. • Instructs and trains personnel in the proper methods and techniques of operation and use of production machines and equipment. Communicates new procedures as necessary. • Consistently follows the escalation process to ensure that equipment issues are diagnosed and repaired in a timely manner to limit downtime. • Performs equipment verifications and component visual inspections to insure all are built in compliance with all current quality standard documentation (Manufacturing Instructions - MI; Bills of Materials - BOM; Standard Instructions - SI; Standard Operating Procedures - SOP). • Verification Visually inspects component parts to insure all are built in compliance with all current quality standard documentation (Manufacturing Instructions - MI; Bills of Materials - BOM; Standard Instructions - SI; Standard Operating Procedures - SOP). • Assists with investigating potential areas for quality and efficiency improvements. • Recommends process adjustments to aid production. Implements changes as directed.
• Recommends and implement improvements to ensure a safe workplace. Identifies, reports, and corrects potential safety hazards as necessary. • Provides training and mentoring to new and existing employees in the role of Machine Operator I and II. • Complies with all GMP’s, SOP’s, MI’s and SI’s during the course of his work. • Complies with facility escalation procedures. • Maintains all required documentation, including production and maintenance logs. SUPERVISORY RESPONSIBILITIES ☐ Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, training and developing employees; planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. ☐ None
QUALIFICATIONS EDUCATION
Education Level
Education Details
Required/Preferred H.S. Diploma High School Diploma Or equivalent education Required Associate's Degree Technical Degree, Certification, or Apprenticeship in Related field. Preferred EXPERIENCE
Experience Level
Experience Details
Required/Preferred 3 years Experience operating equipment, preferably in production environment. Required 1 year Experience as a maintenance mechanic (or similar role) in a production environment. Preferred Other Experience in a medical device manufacturing environment. Preferred SKILLS
Skill Sets
Other Skills
Proficiency Demonstrated analytical skills. Intermediate Demonstrated problem solving skills. Intermediate Excellent collaboration and team building skills. Intermediate Demonstrates a high level of accuracy, even under pressure. Intermediate Strong mechanical skills. Knowledge and practical use of machine tools and hand tools, mechanical aptitude, and program logic controls. Ability to change out simple mechanical components. Intermediate Other. Knowledge of basic electrical and electronic repairs; ability to read and understand manuals and schematics. Ability to change out simple electronic components. Intermediate Experience in a regulated environment. Possesses strong technical aptitude. Basic to intermediate computer skills required (i.e. ability use email, word processing programs, spreadsheet programs, enter information into databases, etc.). Other. Must have ability to perform leadership responsibilities on a fill-in basis including collecting production data, providing training, understanding raw materials requirements,
SKILLS
Skill Sets
Other Skills
Proficiency and implementing production process changes. Other Able to pass a Category C Physical Abilities Exam, as defined by the Occupational Health and Safety Manager. TRAINING/CERTIFICATIONS
List Each Training/Certification
Required/Preferred • Mechanical, Electrical, and Computer certifications. Preferred • Ability to operate power tools and hand tools. Preferred

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