Manufacturing Supervisor

JOB SUMMARY
Within operations, high quality products are manufactured in a safe work environment. The manufacturing supervisor is responsible for achieving and maintaining the production output as documented in the master production schedule or shipment schedule, confirming to; safety, cGMP and lean. (S)He will be working with other manufacturing supervisors. (S)He will be responsible for the core business for the department. (S)He creates a culture in which continuous adhering to, and improvement of, standards is the standard. The manufacturing supervisor leads, supports and coaches a team of colleagues. (S)He ensures a learning and stimulation work environment.

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 position:

o Supports the introduction of New Products/Equipment.
o Providing User Requirements (URS) to (line) Engineering
o Identifies documentation affected (SOP’s and Work Instructions);
o Supports training for manufacturing operators in the correct use of the equipment; and
o Supports the qualification of the equipment
o Leads a Team as part of the End to End production. The supervisor is responsible for
o Assigning operators per team;

• Timely identification of the need for additional Asset(s).
• Ensures the month targets are met according MPS (manufacturing Production Schedules)
• Review and report the performance of the individual team leaders to the next management level and hold at a minimum the 5 performance conversations
• Performs other duties assigned as needed.

o Responsible for keeping all documentation that is necessary for the execution of the process up-to-date
o Performs Periodic Review on his / her team.

• Overseeing activities and tracks metrics in relation to manufacturing steps, processes, sampling and/or design validations.
• evaluation of the available information (i.e. Training, Non conformances, Yield and sick leave.etc);
• report including conclusion; determining required corrections

o Leads investigations of deviations if needed escalates to line specialist and/or line engineers.
o Is responsible for the proper bounding and labeling according procedure
o Ensures documentation is done in timely manner according procedure
o Supports CAPA’s and can be part of an investigation group.
o Supports Operations in his / her area of expertise where it is expected that he / she can solve the most common problems independently
o Not Applicable.
o Acts as an SME for processes for which he / she is responsible
o Completing training on time
o Not performing a GxP activity independently until all training and qualification requirements have been completed and documented
o Identifies improvement options for the processes and equipment. These are weighted and well-founded advice for implementation.
o Supports improvement processes
o Handles Change management of changes which effects employees.

Qualifications

EXPERIENCE AND EDUCATION

o Minimum Educational level: HBO

• Minimum 5 years of working experience.
• Experience in the Medical Device industry or medical field

o Computer skills in relation to usage to automation software such as Excel, Windows, ERP software

• verbal and written communication skills in English and Dutch,
• business/financial acumen,
• six sigma and process excellence tools/methodologies,
• presentation skills,

o Performs on pre determined schedule level checks to ensure quality and reliability

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS.
o Detailed knowledge of the manufacturing Process, end to end.
o Collect and analyze the available data sources to arrive at decision making that is data driven
o Familiar with the CGMP requirements insofar as these relate to his / her work.
o Responsible for being trained at all times in the applicable procedures.
o Familiar with the EHS & S requirements insofar as these relate to his / her work. Responsible for being trained at all times in the applicable procedures.
o Is able to identify continuous improvements in (work) processes and communicate these to line engineer
o Sets the right priorities, where necessary in close coordination with those involved.
o Is focused on ensuring a thorough and flawless production process to meet the highest standards
o 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.
o 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.
o Is open to change, innovation and knows how to actively and effectively translate this into the shop floor
o 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.
o Is able to make well-founded decisions within set frameworks
o Investigates the cause of problems and makes good use of the data. Identifies ideas and actions that focus on structural solutions
o Can manage substantive teams within the department.
o Functions as the primary point of contact of the area/process.
o Has problem solving capabilities

ADDITIONAL POSITION REQUIREMENTS Personal Protective Equipment (PPEs)

• Ear plugs
• Safety Glasses
• Safety Shoes

Cognitive/Behavioral Abilities

• Ability to work in stressful/fast paced environment
• Ability to work and interact with co-workers to accomplish company goals in a team environment
• Analytical/Problem Solving Skills
• Ability to communicate verbally and in writing
• Ability to learn

Occupational Hazards

• Natural & Environmentally Controlled Work Area

PHYSICAL WORKING CONDITIONS / REQUIREMENTS Position Requirement

• Standing (_30__%)
• Sitting (_30__%)
• Walking (_40__%)

Repetitive Hand Motions

• Computer Entry

Lifting/Carrying

• Light (0-15 lbs)

Lifting Requirement

• Ground to Waist
• Waist to Shoulders

Senses

• Talking
• Hearing

RESPONSIBILITY FOR OTHERS & INTERNAL INTERACTIONS

• Reports to the Operations Manager.
• Works with other departments such as quality assurance to ensure that a variety of business transactions are completed and engineering for improvement

EXTERNAL INTERACTIONS
Interaction with an external Auditor is possible.