Production Operator

Lancesoft; Paris (KY); On-site; USD 45,000 - 65,000; Full time

Job summary

Lancesoft in the United States is seeking a manufacturing technician to perform product assembly per written production records while following safety guidelines, and to operate bottling lines when needed.

The role also involves weighing and blending liquids, maintaining accurate production records, reviewing batch records, SOPs and WIs, training associates, and ensuring compliance with ISO 9001 standards. A high school diploma and at least 3 years in a cGMP environment are required.

Qualifications

• High school diploma required.
• Minimum of 3 years prior experience in a cGMP manufacturing environment, with understanding of semi-automated and/or automated equipment preferred.

Responsibilities

• Perform manufacturing and assembly of products per production records.
• Review and suggest changes to batch records, SOPs and WIs.
• Operate bottling lines and packaging when needed.
• Weigh, measure, blend and check liquid raw materials.
• Maintain production records to comply with ISO 9001, SOPs and Work Instructions.
• Train associates and evaluate progress on operation of equipment and chemical processes.

Skills

Safety guidelines

Documentation review

Equipment operation

Batch records

Process improvement

Education

High school diploma

Job description

Duration: 0-6+ Months Shift: 4pm-2:30am, M-Th, OT as needed

MAJOR JOB DUTIES AND RESPONSIBILITIES (List in order of importance)

• Perform manufacturing and assembly of products in accordance with written production records while observing appropriate safety guidelines.
• Required to review and recommend changes to technical documentation, including batch records, WIs and SOPs.
• Operating bottling lines and packaging when needed.
• Weigh, measure, blend and check liquid and chemical raw materials to assure batches manufactured contain proper materials and quantities.
• Maintain proper production records to comply with requirements (ISO 9001: 2000, SOPs and Work Instructions).
• Properly operate chemical operating equipment, transfer pumps, blenders/mixers and conveying equipment with proficiency, including the cleaning and upkeep of equipment.
• Understanding of advance chemical processes from start to finish.
• Properly operate material monitoring devices and weighing systems, including calibration, cleaning and upkeep.
• Properly use safety and environmental control systems, including dust collection and scrubbing devices to ensure proper operation, including cleaning and upkeep.
• Maintain equipment and rooms in proper operating condition by following daily cleaning requirements.
• Perform activities in controlled environment, while assuring the use of appropriate PPE equipment.
• Train associates and evaluate progress on operation of equipment and chemical processes, including safety procedures and proper handling of materials.
• Provide leadership and good work ethics.
• Performs other duties as assigned.

QUALIFICATIONS (Education/Training, Experience and Certifications)

• High school diploma required
• Minimum of 3 years prior experience in a cGMP manufacturing environment, along with general understanding of semi-automated and/or automated equipment is preferred

KNOWLEDGE SKILLS AND ABILITIES (Those necessary to perform the job competently)

• Knowledge of computer applications is desirable
• Ability to evaluate internal customer needs, and respond with appropriate action/delivery

ENVIRONMENTAL WORKING CONDITIONS & PHYSICAL EFFORT (Under Typical Positions)

Frequently exposed to moving mechanical parts, fumes, airborne particles, dust or gases. The employee is occasionally exposed to toxic or caustic chemicals. The noise level in the work environment is usually moderate. Required to stand and walk for a large part of the working day. Physical requirements include talking, hearing, bending/stooping, squatting, reaching above shoulder height, crouching, kneeling, balancing and pushing/pulling. Also requires some lifting/carrying/pushing or pulling up to 50 pounds with or without assistance. Use both hands for repetitive actions such as grasping and manipulating. Specific vision abilities include close vision, peripheral vision, depth perception, and ability to adjust focus.