Clean and Pack Operator

Johnson & Johnson•Raynham, MA

1d•Onsite

About The Position

The Clean and Pack Operator operates varied machinery in an assigned manufacturing cell to produce medical devices, including implants. Equipment and tasks vary by product and cell assignment. Under direction of a supervisor and/or cell lead, the operator helps meet production requirements, maintain product quality, follow equipment maintenance schedules, and comply with safety requirements. Work may include cleaning, labeling, assembly, packaging, finishing, material handling, inventory management, and other manufacturing processes. The operator performs in-process quality checks, completes required production and inspection documentation, and uses technology systems to complete tasks. The role may also include reworking or reprocessing nonconforming products, maintaining equipment as instructed, and partnering with engineering during expansion and validation activities. The operator is expected to follow applicable medical-device manufacturing requirements, company policies, and environmental, health, safety, and sustainability procedures. Regular lifting of up to 25 pounds may be required. The role is located at DePuy in Raynham, Massachusetts.

Requirements

High school diploma or equivalent.
Ability to learn and follow specific procedures according to the department training plan.
Ability to read, understand, and apply safety, operating, and maintenance documentation.
Ability to communicate effectively with a diverse clientele base.
Ability to work cooperatively with coworkers and the public.
Ability to perform duties in accordance with policies and procedures and comply with civil rights requirements.
Understanding of health and safety requirements.
Ability to deliver oral and written communications and use electronic systems.
The job description lists experience levels by operator grade: Operator 1 generally requires 0–2 years; Operator 2, 2–4 years; Operator 3, 4–6 years; and Senior Operator, 6–8 years.
Regular lifting of up to 25 pounds may be required.

Nice To Haves

Lean/Six Sigma knowledge.
Six months or more of hands-on experience in a manufacturing environment.
Awareness of other engineering specialties and upstream stakeholders, including Quality Engineering and New Product Introduction teams.
Advanced knowledge of equipment effectiveness and manufacturing and maintenance excellence concepts, such as OEE and SOL.
Organized, analytical approach to problem solving.
Knowledge of measuring instrumentation and/or measurement techniques.

Responsibilities

Operate equipment and machinery used to manufacture medical devices according to manufacturing processes and quality requirements.
Complete assigned tasks using technology systems such as PLM, MES, Microsoft Office, and ERP systems.
Perform regular operator asset care, including process machine maintenance, and preventative maintenance as instructed.
Complete rework or reprocessing of products rejected by the process when necessary, and work with other production areas and cell leaders to resolve quality problems.
Follow safety practices, job safety analyses, EHS&S policies, procedures, PPE requirements, work practices, and control measures; report incidents and Good Saves and complete required training and CAPAs on time.
Complete in-process quality checks and work with Quality and production employees to resolve problems.
Follow requirements for medical-device manufacturing, including applicable FDA QSR, ISO 9000, and ISO 13485 requirements.
Complete required process documentation, inspection sheets, work instructions, and document traceability records.
Learn and follow department procedures according to the training plan.
Partner with engineering to complete expansion and validation activities on time, acting as a subject matter expert where applicable or providing the appropriate operator subject matter expert contact.
Communicate business-related issues or opportunities to the next management level.
Segregate department waste for proper disposal, including recycling and trash.
Perform assigned cleaning and labeling operations using applicable equipment and measuring instruments.
Perform assigned assembly, packaging, and labeling operations using manual or automatic equipment.
Perform finishing tasks that may include order breakdown, visual inspection, documentation reconciliation, purchase order receipt, shipping, bag-and-tag, and shrink-wrap operations.
Handle product receipt, material handling, storage, cycle counting, and inventory management as assigned.
Operate manufacturing machinery as needed for processes such as cutting, drilling, milling, bending, mixing, freezing, drying, assembly, labeling, and packaging.
Use measuring instruments and hand tools for quality checks and equipment maintenance as required.
Assemble plastic components into larger assemblies, including cannulas, syringes, and dispensers.
Perform other duties as assigned.