Description
SECTION 1: JOB SUMMARY
Is able to operate equipment used for assembly of products and cleans equipment according procedure. Reads and understands the instructions and specifications for operating and preparing equipment
Produces according production schedules and specifications per procedures and job breakdown sheets per Training within Industry (TWI) methodology.
Is responsible for meeting the safety and quality standards during production.
Notes the results of the production in the documentation such as Device History Record (DHR), logbooks or other records.
SECTION 2: 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 Participating in NPI processes and supporting the introduction of new equipment and / or systems.
o Ensures that rules and legislation are followed
o Complies with all applicable environmental, safety and occupational health policies
o Provides tasks when requested
o Operating equipment for the assembly/production of finished device and its intermediate products.
o Cleans and maintains equipment, If maintenance or repair is required then this is escalated to the Sr. Manufacturing Operator
o Communicates business related problems or opportunities to the next management level
o Fills out accurately documentation needed for producing the products
o Uses instructions and specifications to operate and prepare equipment for production
o The Sr. Manufacturing Operator is responsible for keeping all documentation that is related to equipment and necessary for the execution of the process up-to-date
o Handles deviations independently.
- Observes and escalates deviations independently.
- Checks intermediates for defects and removes defect products/intermediates.
- Notification of Supervisor
- Initial notification in the deviation system
- Perform the initial bounding according procedure
- Initial handling the documentation (DHR’s).
- is responsible for timely handling according to the current procedures
o Supports CAPAs. and can be interviewed for root cause analysis.
o Performs troubleshooting activities and if needed escalates the issue to the Supervisor or Line specialist
o Responsible to keep his/her working area in accordance with Good Manufacturing Practices and applicable procedures
o Completing training on time
o Not performing a GxP activity independently until all training and qualification requirements have been completed and documented
o The Sr. Manufacturing Operator identifies improvement options for the line and / or equipment.
o The Sr. Manufacturing Operator Can be part of an improvement project under the guidance of a Line Engineer.
SECTION 4: REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS.
o Detailed knowledge of his / her equipment and process line.
o Can 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.
o 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 introduction in the execution of the core tasks, and on sustainable and stable solutions that meet the needs of the customer / user.
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.
o Acts from the company's 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
SECTION 5: TRAINING PLAN REVIEWED AND/OR UPDATED* (Check all that apply)
Note: If this is a new or updated JD, Training shall be notified per selections below.
☐ Update to an Existing Job Description
☐ Training plan/curriculum reviewed with Training Representative and updated.
☒ Training plan/curriculum reviewed, and no update is required.
☐ New Job Description
☐ Training plan/curriculum implemented together with the Training Representative
☐ Training plan/curriculum reviewed, and no update is required.
SECTION 6: ADDITIONAL POSITION REQUIREMENTS
☐ This Section is Not Applicable
☐ Work Requirements ☒ Personal Protective Equipment (PPEs)
☐ Scheduled work hours ☒ Ear plugs
☐ Overtime ☒ Safety Glasses
☐ On Call (Call in for work) ☒ Safety Shoes
☐ Regulatory/Product Compliance ☐ Powered Industrial Vehicles (PIV)
☐ Operator Certification Program ☐ Safety Gloves
☐ Functional or Performance Testing ☐ Forklift
☐ Motorized Pallet Jack
☒ Cognitive/Behavioral Abilities ☒ Occupational Hazards
☒ Ability to work in stressful/fast paced environment ☐ Machine Operation
☒ Ability to work and interact with co-workers to accomplish company goals in a team environment ☐ Vehicle Operation
☐ Management Skills ☐ Electrical Hazards
☒ Analytical/Problem Solving Skills ☐ Laser Hazards
☒ Ability to communicate verbally and in writing ☐ Noise
☒ Ability to learn ☐ Extreme Heat/Cold
☐ Other Additional Requirements: ☐ Chemicals/Fumes
☐ Dust
☒Natural & Environmentally Controlled Work Area
SECTION 7: PHYSICAL WORKING CONDITIONS / REQUIREMENTS
☐ This Section is Not Applicable
☒ Position Requirement ☒ Repetitive Hand Motions
☒ Standing (_30__%) ☐ Simple Grasp
☐ Kneeling (___%) ☐ Fine Manipulation
☒ Sitting (_30__%) ☐ Twisting Motion
☒ Walking (_40__%) ☒ Computer Entry
☐ Climbing (___%)
☒ Lifting/Carrying ☒ Lifting Requirement
☒ Light (0-15 lbs) ☐ Ground to knees
☐ Medium (16-30 lbs) ☒ Ground to Waist
☐ Heavy (31-50 lbs) ☐ Ground to Shoulders
☐ Heavy (50+ lbs w/assistance or mechanically aided) ☐ Ground to Overhead
☐ Overhead Work ☒ Waist to Shoulders
☐ Pushing ☐ Waist to Overhead
☐ Pulling ☒ Senses
☐ Reaching ☒ Talking
☒ Hearing
☐ Hand & Eye Coordination
SECTION 8: SAFETY TESTS AND MEDICAL SURVIELLANCE REQUIREMENTS
☒ This Section is Not Applicable
☐ SAFETY TESTS ☐ Drug Screen
☐ Biohazards (BBP and parts of LAH) ☐ Chemical and Active Pharmaceutical Ingredient
☐ Powered Industrial Vehicles ☐ Reproductive Health Concern Level:
☐ Bloodborne Pathogen ☐ High
☐ Forklift ☐ Moderate
☐ Motorized Pallet Jack ☐ Low
☐ Ergonomics Risk: ☐ No Concern
☐ High ☐ Respirator Usage (No facial hair)
☐ Moderate ☐ Air Purifying
☐ Low ☐ Sensitizer
☐ Hearing Conservation Program ☐ Supplied Air
☐ Ear protection required ☐ Physical Hazard
☐ Ionizing/Non-Ionizing Radiation ☐ Heights (> 6 ft)
☐ Laser Exposure Testing ☐ Voltage Auth (50–60 AC)
SECTION 9: RESPONSIBILITY FOR OTHERS & INTERNAL INTERACTIONS
- Reports to the Manufacturing Supervisor
- Works with other departments such as quality assurance to ensure that a variety of business transactions are completed and engineering for improvement
SECTION 10: LOCATION & TRAVEL REQUIREMENTS
Primary Work location is Mentor Medical Systems, Zernikedreef 2, Leiden
SECTION 11: EXTERNAL INTERACTIONS
Interaction with an external Auditor is possible.
SECTION 12: APPROVAL
N/A_________- See PLM system for signatures
COMPANY DISCLAIMER
Company management reserves the right to add, delete or otherwise alter assigned duties at any time. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The minimum qualifications listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Qualifications
SECTION 3: EXPERIENCE AND EDUCATION
VMBO or
VAPRO – Process Operator
Minimum 2 years
Understands the Training within Industry methodology and performs level checks on the line to ensure high quality and reliability
- Has computer skills
- Is able to use spreadsheets and databases
- Is able to work according GMP or EHS instructions and laws
Good command of Dutch or English language