Operator 1
Operator 1
Position Summary:
Perform process operations in the manufacture of products for Attwill Medical Solution customers while
maintaining quality standards, good manufacturing practices and following company Standard Operating
Procedures.
Essential Duties and Responsibilities:
• Receive and store products and packaging materials as directed.
• Set up production suites and equipment in accordance with written procedures and company
standards.
• Perform formulation, packaging, and inspection operations in accordance with written
procedures.
• Operate packaging equipment in accordance with written procedures.
• Inspect materials and products and report flaws immediately to management.
• Detect and report machine malfunctions promptly to management.
• Maintain an adequate supply of operating materials for production and obtain additional
materials according to procedures.
• Document production activities on supplied forms.
• Adhere to established company policies and procedures paying special attention to safety
regulations and FDA / cGMP standards.
• Wear personal protective equipment and clothing in accordance with established procedures and
training guidelines.
• Conduct cleaning and sanitation operations as described in established procedures. Maintain a
neat and orderly workplace at all times.
• Prepare orders for shipment according to written shipping orders and established procedures.
• Coordinate the activities of other Operators as assigned by manufacturing management.
• Perform other related duties as assigned.
Supervisory Responsibilities:
• None
Education, Qualifications and Skills:
• High school diploma or equivalent.
• Prior Operator experience
• Demonstrated knowledge and mastery of FDA regulations, job responsibilities/duties and
understanding of the company standards.
• Prior experience in a medical device, pharmaceutical or FDA regulated facility preferred.
Work Environment:
• This job operates in a clerical office, as well as a manufacturing environment. This role routinely
uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax
machines.
• While performing the duties of this job, the employee is frequently exposed to odors, fumes, dust,
or airborne particles, moving mechanical parts and vibration. The noise level in the work
environment and job sites can be loud.
• The physical demands described here are representative of those that must be met by an
employee to successfully perform the essential functions of this job.
• While performing the duties of this job, the employee is regularly required to talk or hear. The
employee frequently is required to stand; walk; use hands to finger, handle or feel; and reach with
hands and arms.
• The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl.
The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities
required by this job include close vision, distance vision, color vision, peripheral vision, depth
perception and ability to adjust focus.
Operator 2
Operator 2
Job Title: Operator 2 Department: Production
Reports To: Production Manager FSLA: Non-Exempt
Approved By: Human resources
Position Summary:
Perform process operations in the manufacture of products for Attwill Medical Solution customers while
maintaining quality standards, good manufacturing practices and following company Standard Operating
Procedures.
Essential Duties and Responsibilities:
• Receive and store products and packaging materials as directed.
• Set up production suites and equipment in accordance with written procedures and company
standards.
• Perform formulation, packaging, and inspection operations in accordance with written
procedures.
• Operate packaging equipment in accordance with written procedures.
• Inspect materials and products and report flaws immediately to management.
• Detect and report machine malfunctions promptly to management.
• Maintain an adequate supply of operating materials for production and obtain additional
materials according to procedures.
• Document production activities on supplied forms.
• Adhere to established company policies and procedures paying special attention to safety
regulations and FDA / cGMP standards.
• Wear personal protective equipment and clothing in accordance with established procedures and
training guidelines.
• Conduct cleaning and sanitation operations as described in established procedures. Always
maintain a neat and orderly workplace.
• Prepare orders for shipment according to written shipping orders and established procedures.
• Perform other related duties as assigned.
Supervisory Responsibilities:
• None
Education, Qualifications and Skills:
• High school diploma or equivalent.
• Prior Operator experience
• Demonstrated knowledge and mastery of FDA regulations, job responsibilities/duties and
understanding of the company standards.
• Prior experience in a medical device, pharmaceutical or FDA regulated facility preferred.
Work Environment:
• This job operates in a clerical office, as well as a manufacturing environment. This role routinely
uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax
machines.
• While performing the duties of this job, the employee is frequently exposed to odors, fumes, dust,
or airborne particles, moving mechanical parts and vibration. The noise level in the work
environment and job sites can be loud.
• The physical demands described here are representative of those that must be met by an
employee to successfully perform the essential functions of this job.
• While performing the duties of this job, the employee is regularly required to talk or hear. The
employee frequently is required to stand; walk; use hands to finger, handle or feel; and reach with
hands and arms.
• The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl.
The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities
required by this job include close vision, distance vision, color vision, peripheral vision, depth
perception and ability to adjust focus.
Maintenance Specialist
Maintenance Specialist
Position Summary:
Under the direction of the Facilities Manager administer departmental document control for Engineering, Maintenance, while performing Maintenance activities and actively coordinating Maintenance Technicians activities.
Essential Duties and Responsibilities:
• Maintain all machinery to ensure it’s at working standards
• Coordinate and mentor maintenance technician activities throughout shift
• Conduct regular inspections of the facilities to detect and resolve problems
• Plan and manage all repair and installation activities
• Ensure all department workers adhere to the safety policies and procedures
• Evaluate repair cost estimates
• Assist in the preventive maintenance program including scheduling, documentation and execution
• Maintain equipment logs / files
• Assist with equipment / system validation, re-validation and periodic certification of production equipment
• Act as subject matter expert for Equipment operation
• Place orders for new supplies when necessary
• Perform refrigeration maintenance including brazing, vacuuming and changing freon, troubleshooting systems
• Perform mechanic duties as required and directed by the Facilities Manager
• Perform other duties as directed and required
Supervisory Responsibilities:
• None
Education, Qualifications and Skills:
• High school diploma or equivalent
• Licensed Refrigeration preferred – or certification type 2
• Demonstrated working knowledge of all mechanical systems
• Prior experience in HVAC or refrigeration preferred
• Ability to learn FDA regulations, job responsibilities/duties and understanding of the company standards
• Ability to use tools and equipment required to perform mechanical responsibilities
• Ability to troubleshoot and repair all production equipment
• Ability to troubleshoot and repair all facilities equipment including HVAC, electrical, refrigeration, vacuum and pressure equipment, etc.
Work Environment:
• This job operates in a manufacturing environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.
• While performing the duties of this job, the employee is frequently exposed to odors, fumes, dust or airborne particles, moving mechanical parts and vibration. The noise level in the work environment and job sites can be loud.
• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
• While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms.
• The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.