All Round Media Creative Intern

Johnson & Johnson is currently seeking a Line Engineer to join our team located in Leiden. (fixed term contract)

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

job summary

The Line Engineer designs comprehensive engineering activities to develop and implement effective, high quality processes and design guidelines for dissemination throughout the division. They Provide complex design reviews and feedback for improvements in manufacturability. They develop equipment, materials, and process performance requirements, perform vendor searches and equipment evaluation to ensure adequate capability to produce quality products in required quantities at effective costs. The Line Engineer designs experiments and capability studies, develops process specifications, and designs and procures process tooling. They also analyse new processes and equipment with the intent of achieving continuous improvement of present methods. They communicate and monitor process and material quality targets. They measure performance to targets and implements remedial actions as instructed and develop process documentation and training materials for new processes, materials, and equipment.

DUTIES & RESPONSIBILITIES

Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this implies:

o Follows the CREDO and stimulates empowerment.

New Product Introduction (NPI)

o The Line Engineer participates in NPI processes and supports the introduction of new equipment and / or systems.

• testing new equipment and / or systems in consultation with MPS Process.

• ensuring adequate documentation for the equipment (SOPs and Work Instructions);

• provide training for manufacturing operators in the correct use of the equipment; and ensuring the qualification of the equipment and, if necessary, validation of supporting processes (such as cleaning).

Production Process

Responsibilities

o Responsible for realizing department- and organization goals.

o Taking care of the maintenance of this equipment and / or systems, including addressing (acute) process disruptions; Maintains and performs basic repairs on equipment as needed. Schedules maintenance and/or repairs on equipment as directed.

o Improving equipment and / or systems. All activities must comply with the requirements of cGMP and the EHS & S guidelines.

o Represents the department by maintaining contact between different departments both inside and outside of operations and enhance the collaboration and synergy between departments.

o Ensure that the department works according to the required standards (cGMP, EHSS and process excellence) and drive its continuous improvement.

o Responsible for an effective communication between different locations, customers, contacts and other internal/external departments.

o Works together with Quality Engineering to ensure Failure Mode Effects Analysis (FMEA), Process Control Plans (PCP), Failure Modes Effects and Criticality Analysis (FMECA), and Process Specifications exist, are current, and effective for assigned areas.

o Understand Yield for all processes and identify/execute project to improve it.

o Supports Operations in his / her area of expertise where it is expected that he / she can solve the most common problems independently. Performs troubleshooting activities, possibly under the supervision of a line engineer.

o Supports Operations in his / her area of expertise in a structure in which he / she is expected to be able to solve the most common problems independently.

o Acts as an SME for processes for which he / she is responsible.

o Completing training on time

Documentation

o Gathers and compiles accurate records/documentation related to quality, work in progress, test results,

Periodic Review

o keeping the data relating to the asset up to date and determined as part of the annual cycle for Assets, including supplying this data for the Five Year plan.

o timely identification of the need for replacement of the Asset.

EHS Management Systems

• Ensures a safe environment and follows all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition.

• Is supporting the different of chapters of IOSS system

• Seeks advice if EHS needs to be improved from the EHS Engineer / Manager

• Report any EHS issue using the EHS Management system

• Has access to the Curve system to perform investigations and actions

Quality Management System

• The line engineer is responsible for keeping all documentation that is related to equipment and necessary for the execution of the process up-to-date

• The Line Engineer performs Periodic Review of processes:

• evaluation of the available information;(Nc’s, Capa’s, Complaints related to a process, etc
• report including conclusion.
• determining required corrections; and
• approval of the required documentation
• identify and address issues with Assets (e.g., recurring breakdowns and recurring deviations);
• Compiles records and reports on quality inspection results. (Yield)
• handles deviations independently.
• leading a investigation team if necessary.
• manage the NCR’s and CAPA process by documenting, investigating, root cause analysis, and implementing corrective actions for non-conformances.
• conducting the root cause investigation.
• performing the product impact analysis.
• the identification of corrective and / or preventive measures.
• handling the documentation associated with the deviation.
• responsible for timely handling according to the current procedures
• supports CAPAs. and is responsible for timely processing according to the current procedures.
• not performing a GxP activity independently until all training and qualification requirements have been completed and documented.
• identifies improvement options for the equipment. These are weighted and well-founded advice for implementation.
• leads improvement processes.

Project and Change Management

• Identifies improvement options for the equipment. These are weighted and well-founded advice for implementation.
• Supports improvement processes under the guidance of a Line Engineer.
• Leads improvement processes with a maximum capex spent of < 500K (indication)
• Handles Change Controls independently. This implies: the preparation of a Change Request or change forms
• Be the representative of the department in multidisciplinary and global projects.
• Performs other duties assigned as needed.

Qualifications

EXPERIENCE AND EDUCATION

• Bachelor with 2 years of experience.
• Experience in the Medical Device industry or medical field
• Experience with Lean (Greenbelt) or Six Sigma is required.
• Verbal and written communication skills in English and Dutch
• Demonstrated knowledge of manufacturing principles and practices, and procedures
• Computer skills in relation to usage to automation software such as Excel, Windows, ERP software
• Ability to work cooperatively with coworkers
• Six sigma and process excellence tools/methodologies
• Fulfilled the training to obtain full VCA certification
• Understands and uses the methodology of TWI

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS .

• Detailed knowledge of his / her equipment and knowledge of multiple types of equipment.

• Knowledge of automation and the associated procedures to enable him / her to assess whether improvements are necessary and the automation for his / her equipment meets current standards.

• Can collect and analyze the available data sources to arrive at decision making that is data driven.

• Familiar with the CGMP requirements insofar as these relate to his / her work.

• Responsible for being trained at all times in the applicable procedures.

• Familiar with the EHS & S requirements insofar as these relate to his / her work. The Line Engineer is responsible for being trained at all times in the applicable procedures.

• Be the EHS ambassador on the shopfloor

• Is able to identify continuous improvements in (work) processes and to implement these.

• Sets the right priorities, where necessary in close coordination with those involved

• Is focused on ensuring a thorough and flawless introduction in the execution of the core tasks, and on sustainable and stable solutions that meet the needs of the customer / user.

• Builds strong and productive relationships with all different departments and layers within the Leiden site and within the J&J network. Shows respect for and listens to others. Is aware of their own behavior and the effect on others. Is able to effectively present improvement proposals to stakeholders and thereby guide the decision-making process. Acts from the companys interests and knows how to frame initiatives within the objectives of the department and the site.

• Is open to receiving / giving transparent and constructive feedback, learns from mistakes and takes the initiative to improve his own work and to realize personal development goals.

• Is open to change, innovation and knows how to actively and effectively translate this into the shop floor

• Driven to achieve business objectives with a high degree of pro-activity, organizational sensitivity and independence. Can identify business goals and translate them into a practical solution in the workplace. Keep an eye on the goal.

• Can make well-founded decisions within set frameworks

• Investigates the cause of problems and makes good use of the data. Identifies ideas and actions that focus on structural solutions

• Keeps calm and radiates tranquility to the surroundings even in complex situations.

• Interpret facts, makes connections between multiple signals and looks for potential root causes. Signals obstacles for the medium term.

• Lead by example. Has an exemplary function in its own behavior and encourages this.

• Make optimal use of diverse talent, knowledge base and skills.

• Development of individuals, the department and the team to a higher level