Senior Operators

• Operate, maintain, and troubleshoot process equipment utilized in the cleanroom label and sterile disinfectant business, and be able to make minor equipment adjustments as needed.
• Responsible for performing precise measurements and using measurement equipment to accurately add chemicals to batches.
• Pass and maintain gowning qualification to perform Gowning Requirement for ISO Class 5 Clean room operations or ISO Class 7 Clean room operations.
• Responsible for accurately maintaining legible and accurate records, required logs, books, records,  and other procedures to comply with regulatory requirements, Good Manufacturing Practices (GMP), Quality Systems Regulations, Standard Operating Procedures (SOP’s), and Health and Safety requirements.
• Interface with QA/QC/Material departments during course of work to coordinate inspections and efficient flow of subassemblies and completed product.
• Enter and record production activities in production log sheet systems for specific work orders.
• Follow applicable Standard Operating Procedures, Quality System Regulations and ISO 9001 & ISO13485 requirements.
• Responsible for reporting all discrepancies to the Supervisor or Production Manager.
• Support department and plant Safety goals by continuously demonstrating safe behaviour.
• Maintain a clean and orderly work area.
• Ability to work flexible shifts, and flexible days within the week to meet batch milestone requirements
• Perform other manufacturing activities as assigned by the department leadership

DESIRED MINIMUM QUALIFICATIONS

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.

• High School diploma or equivalent.
• 0 – 2 years of chemical processing experience or batch mixing in Medical Device or Pharmaceutical manufacturing industry.   Production experience is highly desirable.
• Basic computer skills for email and data entry.
• Must read, write and speak in English & Bahasa Melayu, and communicate clearly and concisely.
• Fundamental understanding of mathematics and chemistry.
• Able to participate in a team-oriented environment, willingness to assist and train others
• Able to work independently with minimal supervision
• Ability to operate, maintain and troubleshoot process equipment, and make minor adjustments as needed.
• Ability to gown to ISO Class 5 and 7 Clean Room standards.
• Able to work overtime

PHYSICAL REQUIREMENTS

The employee must be able to stand for 8 hours, lift up to 60lbs and climb ladders without assistance. The employee is required to go to all areas of the company.

• Must be able to bend and lift 30 to 60 lbs without assistance on a daily basis.
• Ability to gown to ISO Class 5 Clean Room standards and/or additional Clean room clothing
• Ability to gown to ISO Class 7 Clean Room standards and/or additional Clean room clothing
• Ability to stand for 8 hours
• Must be able to climb step ladders, without assistance
• Vision: Requires eye sight correctable to 20/25 to detect any defect in product/materials. Visual acuity adequate to perform job duties, including meeting all of the quality reclassification.