About MedTech

Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

We are searching for the best talent for Department Lead Operator to be in Irving, Texas.

Duties and Responsibilities:

Under and in accordance with all applicable federal, state and local laws/regulations and company procedures and guidelines:

• Executes and monitors manufacturing processes according to operational procedures. Establishes priorities based on production schedule.
• Participates in cleaning equipment and clean rooms as necessary.
• Takes readings of equipment and systems.
• Verifies and interprets parameters to ensure compliance.
• Takes samples and performs tests during process according to standard procedures. Participates in projects focused on process development and/or improvement, cost controls and new product manufacturing.
• Performs equipment maintenance, conditioning, standardization and calibration as needed.
• Troubleshoots equipment issues.
• Handles, stores and disposes of hazardous and nonhazardous materials in compliance with company policy and regulatory requirements.
• Handles chemicals appropriately using required safety equipment.
• Participates in the execution of validation/revalidation protocols.
• Performs all essential functions listed for Lead Operator (PG 22)
• Oversees and coaches associates through basic performance problems
• Coordinates and leads day-to-day activities in the production manufacturing area as necessary, in alignment with immediate or direct supervision.
• Delivers department outputs daily for assigned shift
• Monitors assigned area and reallocates resources as necessary to meet schedule requirements within the department.
• Collaborates with Supervisors on all department performance and operator issues, coordinating priorities with other shift Leads.
• Trains new personnel in the area.
• Ensures training adherence and on time completions for the shift.
• Supports projects and validations as needed.
• Ensures cleanliness and housekeeping maintenance of assigned area.
• Supports preparation of weekly staffing plan for the area.
• Requests raw materials from warehouse as needed.
• Leads Tier 1 meetings.
• Ensures schedule/plan attainment.
• Provides recommendations and opportunities for OEE improvements.
• Promotes a safety focused culture and the Good Saves program in assigned area.
• Ensures that employees within shift are adhering to GMPs, GDPs and acting in accordance to their process specifications.
• Supports and sustains 6S program.
• Maintains a safe, clean and well organized work area in good operating condition.
• Opens work orders if repairs are required in the facilities or the equipment.
• Reports any associates who are not behaving in accordance with the J&J established policies to the Supervisor or Manufacturing Manager.
• Escalates major safety, quality or equipment downtime situation to the shift Supervisor or Manufacturing Manager
• Demonstrates leadership qualities to create a team-based, non-threatening environment that promotes teamwork and open exchanges of ideas.
• Ensures cross shift communication and participation to share production results and identify areas of improvement.
• Demonstrates consistent and effective job performance that demonstrates good quality and quantity of work, and dependability.
• Communicates problems and potential solutions to Supervisors, technicians, engineers and incoming production shifts.
• Demonstrates ability to manage complexity.
• Promotes innovation and continuous learning of other associates.
• Delegates work of others, gathers information and completes reports as requested.
• Assists in the hiring and review process.
• Helps with scheduling overtime, work assignments and vacations and moves associates to balance workloads and meet daily production requirements.
• Communicates business related issues and opportunities to next management level.
• Ensures subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition.
• Ensures compliance with all Federal, State, local and Company regulations, policies, and procedures.
• Performs other duties assigned as needed

Qualifications

EXPERIENCE AND EDUCATION

• Minimum of 1 to 3 years manufacturing experience directly required.
• Associates Degree preferred.
• Basic Computer and database management skills.
• Experience with Microsoft Word and Excel.
• Excellent communication and interpersonal relation skills.
• Excellent problem solving skills.
• Must have mechanical skills and provide documentation of mechanical skills and experience, upon requests.
• Excellent understanding of safety requirements.
• Excellent understanding of and GDP and GMP requirements.
• Working knowledge of basic hand tools (i.e. screwdrivers, wrenches, snips, cutters) and inspection equipment (i.e. optical comparators, micrometers, microscopes, plug gauges).
• Working knowledge of shop math such as decimals, fractions, and tolerances.

ADDITIONAL POSITION REQUIREMENTS

• Work in a team environment behaving in a CREDO based respectful manner.
• Comply with all federally regulated programs.
• Adhere to J&J environmental and safety policies and guidelines.
• Comply with all job specific safety procedures and utilize PPE when necessary.
• Comply with quality system requirements as defined within procedures and instructions.
• Support Maintenance Excellence (ME2) including 6S and Operator Asset Care.
• Accurately complete records as defined within the job procedures (e.g. manual and/or electronic documentation).
• Consistently meet required Training due date targets.
• Perform other work-related duties as assigned by supervisor/facilitator.
• Follow current compliance regulations and standards.
• Adhere to FDA quality and worldwide quality systems.
• Support Plant Diversity Process.
• Ensure safe working conditions and practices in the department.
• Demonstrate ability to consistently meet required work performance targets.
• Demonstrate teamwork in identifying, evaluating, and resolving problems within the department.
• Cover for other operators during breaks, absences, leaves, vacations, etc.
• Perform physical inventory and cycle counting.