דרושים Controls Technician Nights ב-West Pharma ב-United States, Walker

The Controls Technician is responsible for maintaining, troubleshooting, and continuous improvement on electrical and automated control systems within our medical device manufacturing facility. This role ensures that all production equipment functions efficiently and safely, complying with industry standards and regulations.

• Diagnose and resolve issues with automated assembly equipment, including PLCs, HMIs, robots, vision systems, sensors, and other control devices. Assist the assembly maintenance team with resolving electrical and controls related issues and helping to resolve escalated equipment issues.
• Perform regular maintenance on electrical and control systems to ensure continuous production operations.
• Collaborate with engineering and production teams to identify opportunities for process and system improvements. Contribute to continuous process improvement efforts to reduce scrap, cycle times, improve efficiency, and eliminate waste within the production environment.
• Assist with the installation and commissioning of new control systems and equipment upgrades.
• Maintain accurate records of system layouts, wiring diagrams, and maintenance logs.
• Ensure all control systems comply with relevant medical device manufacturing regulations and quality standards, such as ISO 13485 and FDA guidelines.
• Adhere to all safety and environmental policies and standards in the execution of work duties.
• Other duties as assigned.

• Strong analytical and troubleshooting skills.

• Excellent verbal and written communication skills.

• Ability to work collaboratively in a fast-paced, cross-functional team environment.

• Associate degree in Electrical Engineering, Industrial Automation, or a related field.

• 3+ years of experience in a controls technician role within a manufacturing environment, preferably in the medical device sector.
• Proficiency with PLC programming (e.g., Allen-Bradley, Siemens), HMI development, Vision programming (e.g., Cognex, Keyence), Robots (e.g., Fanuc, ABB), and SCADA systems.
• Familiarity with GMP, ISO 13485, and FDA regulations in medical device manufacturing.

• Experience in automation equipment used in medical device industry or other regulated industry.
• Knowledge of quality systems requirements, FDA Quality System Regulation, cGMP and ISO 9002.

• Must be able to work a 40-hour work week, plus overtime and/or irregular hours as required to complete assignments. May stand or sit for extended periods of time. Must transport oneself to and from other areas of the facility and travel to other divisions when necessary. Must have good visual acuity and distinguish color differences for product and safety issues.
• Medical Device manufacturing requires strict adherence to standards. Working environment is a clean room manufacturing facility, which houses plastic injection molding machines. Must work constructively in an environment that may be stressful due to competing resources while at all times maintaining company confidentiality.

The Controls Technician is responsible for maintaining, troubleshooting, and continuous improvement on electrical and automated control systems within our medical device manufacturing facility. This role ensures that all production equipment functions efficiently and safely, complying with industry standards and regulations.

• Diagnose and resolve issues with automated assembly equipment, including PLCs, HMIs, robots, vision systems, sensors, and other control devices. Assist the assembly maintenance team with resolving electrical and controls related issues and helping to resolve escalated equipment issues.
• Perform regular maintenance on electrical and control systems to ensure continuous production operations.
• Collaborate with engineering and production teams to identify opportunities for process and system improvements. Contribute to continuous process improvement efforts to reduce scrap, cycle times, improve efficiency, and eliminate waste within the production environment.
• Assist with the installation and commissioning of new control systems and equipment upgrades.
• Maintain accurate records of system layouts, wiring diagrams, and maintenance logs.
• Ensure all control systems comply with relevant medical device manufacturing regulations and quality standards, such as ISO 13485 and FDA guidelines.
• Adhere to all safety and environmental policies and standards in the execution of work duties.
• Other duties as assigned.

• Associate degree in Electrical Engineering, Industrial Automation, or a related field.

• 3+ years of experience in a controls technician role within a manufacturing environment, preferably in the medical device sector.
• Proficiency with PLC programming (e.g., Allen-Bradley, Siemens), HMI development, Vision programming (e.g., Cognex, Keyence), Robots (e.g., Fanuc, ABB), and SCADA systems.

• Familiarity with GMP, ISO 13485, and FDA regulations in medical device manufacturing.
• Strong analytical and troubleshooting skills.
• Excellent verbal and written communication skills.
• Ability to work collaboratively in a fast-paced, cross-functional team environment.

• Must be able to perform job duties as required with limited physical demands.

In this role, you will supervise technicians in a manufacturing environment and be responsible for maintaining equipment of automated assembly lines. You will be the first point of contact during the escalation of any technical issues regarding automation during your teams’ shifts and will be responsible for teaching and encouraging growth in all night shift technicians.

• Ensures effective employee relations. Provides employee coaching, development, and performance reviews. Administers the hiring, termination, and disciplinary process for night shift technicians under your supervision. Resolves employee issues through problem resolution.
• Responsible for ensuring applicable training and compliance associated with work area and products.
• Responsible for shift personnel scheduling and assignments, verbal communications and visual checks of all work activity for the duration of each assigned shift.
• Lead and mentor technician team to achieve site and department goals in a fast-paced environment.
• Routinely evaluate and review employee performance.
• Technical and hands-on automated equipment troubleshooting, repair, and improvements.
• Analyze data to drive improvements, determine prioritization, and identify opportunities.
• Lead and provide mentorship in root cause and corrective action (RCCA).
• Assess and perform/schedule technical training, including electromechanical systems, pneumatics, servos, PLCs, schematic reading/interpretation, new technology, etc.
• Assist engineering to develop design concepts for new automation.
• Provide engineering assistance to ensure machinery and processes are at an optimum level.
• Promote and support a Lean Manufacturing environment within the facility.
• Research new technologies and methodologies to use in the facility.
• Provide a “Customer Service” attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.
• Conform with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
• Exhibit regular, reliable, punctual and predictable attendance.
• Perform other duties as assigned based on business needs.

• Associates in Engineering or Science field is preferred.

• Experience: 5-8 years of experience
• 2+ years of managerial or supervisory experience in manufacturing environment required.
• Knowledge of manufacturing processes, workflows, production equipment and industrial techniques.
• Must have effective problem solving and interpersonal skills.

• Strong leadership skills and interpersonal skills to communicate with peers.
• Possess broad based knowledge to successfully troubleshoot, diagnose, and solve problems that relate to mechanical, electrical, and pneumatic systems.
• Experience in medical device industry or other regulated industry.
• Ability to remain calm while working under pressure.
• Demonstrate knowledge concerning general safety protocol and procedures.
• Knowledge of quality systems requirements, FDA Quality System Regulation, cGMP, and ISO 9002.
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description.
• Support and contribute in Lean Sigma programs and activities towards delivery of the set target
• Able to comply with the company’s safety policy and quality policy at all times.

• Must be able to perform job duties as required with limited physical demands.

In this role, you will supervise technicians in a manufacturing environment and be responsible for maintaining equipment of automated assembly lines. You will be the first point of contact during the escalation of any technical issues regarding automation during your teams’ shifts and will be responsible for teaching and encouraging growth in all night shift technicians.

• Ensures effective employee relations. Provides employee coaching, development, and performance reviews. Administers the hiring, termination, and disciplinary process for night shift technicians under your supervision. Resolves employee issues through problem resolution.
• Responsible for ensuring applicable training and compliance associated with work area and products.
• Responsible for shift personnel scheduling and assignments, verbal communications and visual checks of all work activity for the duration of each assigned shift.
• Lead and mentor technician team to achieve site and department goals in a fast-paced environment.
• Routinely evaluate and review employee performance.
• Technical and hands-on automated equipment troubleshooting, repair, and improvements.
• Analyze data to drive improvements, determine prioritization, and identify opportunities.
• Lead and provide mentorship in root cause and corrective action (RCCA).
• Assess and perform/schedule technical training, including electromechanical systems, pneumatics, servos, PLCs, schematic reading/interpretation, new technology, etc.
• Assist engineering to develop design concepts for new automation.
• Provide engineering assistance to ensure machinery and processes are at an optimum level.
• Promote and support a Lean Manufacturing environment within the facility.
• Research new technologies and methodologies to use in the facility.
• Provide a “Customer Service” attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.
• Conform with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
• Exhibit regular, reliable, punctual and predictable attendance.
• Perform other duties as assigned based on business needs.

• Associates in Engineering or Science field is preferred.

• Experience: 5-8 years of experience
• 2+ years of managerial or supervisory experience in manufacturing environment required.
• Knowledge of manufacturing processes, workflows, production equipment and industrial techniques.
• Must have effective problem solving and interpersonal skills.

• Strong leadership skills and interpersonal skills to communicate with peers.
• Possess broad based knowledge to successfully troubleshoot, diagnose, and solve problems that relate to mechanical, electrical, and pneumatic systems.
• Experience in medical device industry or other regulated industry.
• Ability to remain calm while working under pressure.
• Demonstrate knowledge concerning general safety protocol and procedures.
• Knowledge of quality systems requirements, FDA Quality System Regulation, cGMP, and ISO 9002.
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description.
• Support and contribute in Lean Sigma programs and activities towards delivery of the set target
• Able to comply with the company’s safety policy and quality policy at all times.

• Must be able to perform job duties as required with limited physical demands.

• Cleans and services tool and components, inspects tools for damage or wear.
• Identifies proper cleaning techniques of all tool components and plates.
• Identifies mold location and safe usage of mold rack and carts.
• Safely operates equipment and machinery in tooling repair area; must have an understanding of safety of self and others in eye, ear and skin protection.
• Performs basic machining operations for Tooling as well as other departments.
• Communicate effectively with stakeholders to ensure proper and timely tool staging, repair completion and end of shift reporting.
• Assists with maintaining spare parts inventory and completes necessary records and requisitions for materials/supplies.
• Maintain open and effective communication with the technicians, supervisors, and process engineers on Material related issues.
• Contribute to continuous process improvement efforts to reduce scrap, cycle times, improve efficiency, and eliminate waste within the production environment.
• Provides a “Customer Service” attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.
• Maintains a clean, orderly, and safe workstation and environment at all times.
• Other duties as assigned.

• High School Diploma or GED required

• Minimum 1 year experience in a manufacturing environment

• Prior experience in a tooling environment.
• Experience with cGMP, ISO, and medical device manufacturing preferred.
• Must have working knowledge of plastic injection molding industry.
• Strong mechanical aptitude with good basic math skills (arithmetic, decimals, & percentages)
• Knowledge of blueprint reading, geometric dimensioning and tolerance practices with some understanding of statistical quality concepts
• Must have good interpersonal communication skills, be detail oriented, organized and flexible

• Must be able to work assigned shift(s) with overtime as required to complete assignments if necessary.
• Sitting and/or standing for extended periods may occur as well as getting to and from various locations within facility.
• If specifically necessitated by customer requirements, must be able to see with or without corrective lenses and distinguish color differences for product and safety issues.
• Hearing ability should be sufficient to hear and react to audible alarms from distances up to 150 feet.
• The ability to be able to lift and carry various items up to 50 pounds

• Support Key Activities within the Process Engineering Dept.
• Assist with the execution of equipment / process qualifications as required.
• Read and understand the execution of validation documentation protocols and summary reports.
• Assist with the implementation of equipment and/or process changes in line with the necessary change control process.
• Participate in the efforts towards continuous improvement on quality, service, HSE and costs, to achieve state-of-the-art manufacturing processes.
• Participate with the modifications, improvements, or validations of existing or new products, processes, tooling, equipment.
• Review processes continually to ensure their quality and efficiency.
• Participate in process improvement projects.
• Work closely with Process Engineering on the introduction of new equipment or technology.
• Assist with ‘trouble shooting’ improvements when required in production.
• Review process engineering documentation and safeguard confidential information.
• Work within formal systems, such as cGMP, ISO, CE to ensure that new processes and improvements conform with quality and legal requirements.
• Support to the Global (Process) Engineering group. Support local projects to implement the Global PE initiatives.
• Ensure that all projects and activities are in compliance with local, regional and best practice requirements on HSE and meet authority requirements.
• Keep Process Engineering manager advised of any unusual situation which might impair or affect safety, quality, production output or assigned projects.
• Transfer of process knowledge to Operations Group as required.
• Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct.
• Compliance to all local site Environmental, Health and Safety regulations.
• Compliance to all local site company policies, procedures and corporate policies
• Other duties as assigned

• 2+ years’ experience in a similar position within the manufacturing industry, ideally in a regulated industry.
• Basic knowledge of LEAN 6 sigma manufacturing principles
• Yellow belt of higher an advantage.
• Experience with continuous improvement of processes and validations of processes/equipment
• cGMP experience is an advantage.
• Self-motivated, results- and solution-oriented personality
• Well-developed communication and interpersonal skills.
• Good organizational and project management skills.
• Highly analytical and structured way of working
• Experience with drafting and execution of validation protocols and associated documentation.
• Knowledge of CAPA systems and use of formal problem-solving tools.

In this role, you will be responsible for maintaining operational efficiency of automated assembly lines, provide support to shift operations as request by the shift leader/production manager, and develop long-term predictive/preventative maintenance plans for all assembly equipment.

• Logically troubleshoots and repairs assembly lines and related equipment.
• Assists shift lead in maintaining quality of finished product through proper machine operation.
• Responsible for maintaining spare parts inventory with a proper cataloging of parts.
• Provide a timely notification to shift lead of maintenance issues and downtime.
• Reviews line history and documentation to enhance line efficiencies. Follows escalation plan to minimize downtime.
• Maintains and updates all equipment log books with accurate repair/adjustment information.
• Interfaces daily with shift leader and technician at shift change.
• Maintains cleanliness of all equipment.
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
• Exhibits regular, reliable, punctual and predictable attendance.
• Performs other duties as assigned based on business needs.

• Education: High School or equivalent

• 2 years of experience in related industry

• Education: 2-year technical degree
• Background in medical devices/pharmaceutical would be a plus.
• Knowledge of quality systems requirements, FDA Quality System Regulation, cGMP and ISO 9002.
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Support and contribute in Lean Sigma programs and activities towards delivery of the set target
• Able to comply with the company’s safety policy at all times
• Able to comply with the company’s quality policy at all times.

• Must be able to work a 40-hour work week, plus overtime and/or irregular hours as required to complete assignments. May stand or sit for extended periods of time. Must transport oneself to and from other areas of the facility and travel to other divisions when necessary. Must have good visual acuity. If specifically necessitated by customer requirements, must be able to see with or without corrective lenses and distinguish color differences for product and safety issues.
• Medical Device manufacturing requires strict adherence to standards . Working environment is a manufacturing facility, which houses plastic injection molding machines. Must tolerate fumes and particulate generated from various plastics . Work areas are equipped with adequate lighting, cooling/heating and equipment that are in a good working condition. Must work constructively in an environment that may always be stressful due to competing resources while maintaining company confidentiality.