Process Maintenance Technician
Job Description
Job Description:
Position Overview:
The Process Technician is responsible for operating the production line, equipment setup, change part control, mechanical adjustments, troubleshooting technical issues, and verification of manufacturers’ specifications. Assist manufacturing operators by performing standardized work to reduce process variability and reduce waste. Ensure that change parts meet manufacturer specifications and machines are appropriately setup for operation before the start of each production run to minimize production downtime. Responsible for participating in small scale process improvement projects to improve the setup process and change part management practices.
The Process Technician is responsible for operating the production line, equipment setup, change part control, mechanical adjustments, troubleshooting technical issues, and verification of manufacturers’ specifications. Assist manufacturing operators by performing standardized work to reduce process variability and reduce waste. Ensure that change parts meet manufacturer specifications and machines are appropriately setup for operation before the start of each production run to minimize production downtime. Responsible for participating in small scale process improvement projects to improve the setup process and change part management practices.
II. Specific Tasks, Duties and Responsibilities:
RESPONSIBILITIES INCLUDE, BUT ARE NOT LIMITED TO:
• Operate production line to maximize production with high quality output
• Follow standardized work to perform equipment setups and manage equipment change parts.
• Understand and follow all cGMP and SOP regulations.
• Perform detailed cleaning of encapsulation change parts using various cleaning solutions
• Accurately complete all applicable documentation pertaining to daily tasks.
• Monitor key change part parameters in accordance with manufacturer specifications
• Provide technical troubleshooting to investigate alignment, production and setup issues.
• Provides data and possible solutions for PR’s related setup.
• Acts as a team member to help successfully build cross-functional collaboration.
• Manage setup schedule to minimize production downtime.
• Monitor and build strong safety culture,
• Identify hazards and support countermeasure implementation.
RESPONSIBILITIES INCLUDE, BUT ARE NOT LIMITED TO:
• Operate production line to maximize production with high quality output
• Follow standardized work to perform equipment setups and manage equipment change parts.
• Understand and follow all cGMP and SOP regulations.
• Perform detailed cleaning of encapsulation change parts using various cleaning solutions
• Accurately complete all applicable documentation pertaining to daily tasks.
• Monitor key change part parameters in accordance with manufacturer specifications
• Provide technical troubleshooting to investigate alignment, production and setup issues.
• Provides data and possible solutions for PR’s related setup.
• Acts as a team member to help successfully build cross-functional collaboration.
• Manage setup schedule to minimize production downtime.
• Monitor and build strong safety culture,
• Identify hazards and support countermeasure implementation.
III. Essential Skills and Experience:
• Education or Equivalent: (Minimum required to perform job)
• Minimum of a High School Degree with a two-year technical or Associate’s degree preferred.
• Experience: (List unique knowledge skills, or problem-solving requirements)
• Preferred 3-5 years of prior experience in a technical manufacturing role focusing on mechanical
alignment and change over skills.
• Prior experience working in a pharmaceutical, biotech, or food manufacturing environment (regulated by GMP standards and requirements) is preferred; with specific experience in food or nutraceutical manufacturing
• Education or Equivalent: (Minimum required to perform job)
• Minimum of a High School Degree with a two-year technical or Associate’s degree preferred.
• Experience: (List unique knowledge skills, or problem-solving requirements)
• Preferred 3-5 years of prior experience in a technical manufacturing role focusing on mechanical
alignment and change over skills.
• Prior experience working in a pharmaceutical, biotech, or food manufacturing environment (regulated by GMP standards and requirements) is preferred; with specific experience in food or nutraceutical manufacturing
Knowledge/Skills Requirements: (List unique knowledge skills, or problem-solving requirements)
• Ability to troubleshoot mechanical problems.
• Knowledge of mechanical systems and components.
• Understanding of equipment used in the manufacturing.
• Ability to communicate effectively with engineers, manufacturing operators, customers, staff,
and other personnel.
• Ability to provide detailed documentation of daily activities.
• Ability to use calibrated measurement tools.
• Required to read and interpret mechanical drawings.
• Experience with Microsoft Office.
• Ability to troubleshoot mechanical problems.
• Knowledge of mechanical systems and components.
• Understanding of equipment used in the manufacturing.
• Ability to communicate effectively with engineers, manufacturing operators, customers, staff,
and other personnel.
• Ability to provide detailed documentation of daily activities.
• Ability to use calibrated measurement tools.
• Required to read and interpret mechanical drawings.
• Experience with Microsoft Office.
Job Qualifications:
Minimum Requirements:
• High school diploma or equivalent. May substitute equivalent years of pharmaceutical manufacturing supervisory experience for education.
• 2 years of pharmaceutical manufacturing experience (or applicable experience in a cGMP environment).
• Must have a thorough knowledge of the equipment and processes used in the facility and within the pharmaceutical industry or equivalent manufacturing experience.
• Must have a thorough knowledge of cGMP, FDA and DEA guidelines and how to apply them effectively.
• Thorough knowledge of Solid Dosage manufacturing preferred.
• Excellent computer skills.
• Able to manage priorities and projects prioritizing effectively. Must communicate clearly, and manage people well.
• Capability to work in a matrix organization.
• Must be able to wear safety glasses, or specified eye protection, in all designated areas
• Must be able to follow any applicable plant safety requirements
• Must be fit-tested, trained and capable of wearing air purifying respirator
• Must be trained in plant hazardous material procedures
• Must be able to use approved fall prevention devices when performing elevated tasks
• Must be capable of wearing steel-toed safety shoes for 8 to 12 hours a day, depending on duration of the shift
• High school diploma or equivalent. May substitute equivalent years of pharmaceutical manufacturing supervisory experience for education.
• 2 years of pharmaceutical manufacturing experience (or applicable experience in a cGMP environment).
• Must have a thorough knowledge of the equipment and processes used in the facility and within the pharmaceutical industry or equivalent manufacturing experience.
• Must have a thorough knowledge of cGMP, FDA and DEA guidelines and how to apply them effectively.
• Thorough knowledge of Solid Dosage manufacturing preferred.
• Excellent computer skills.
• Able to manage priorities and projects prioritizing effectively. Must communicate clearly, and manage people well.
• Capability to work in a matrix organization.
• Must be able to wear safety glasses, or specified eye protection, in all designated areas
• Must be able to follow any applicable plant safety requirements
• Must be fit-tested, trained and capable of wearing air purifying respirator
• Must be trained in plant hazardous material procedures
• Must be able to use approved fall prevention devices when performing elevated tasks
• Must be capable of wearing steel-toed safety shoes for 8 to 12 hours a day, depending on duration of the shift
