Cleanroom Manufacturing Technician - 12 HR Shift

CLEANROOM MANUFACTURING TECHNICIAN

“Come build a Career with our Growing, Fast-Paced, Customer-Focused Company that fosters Training & Professional Development!” 

Do you have experience in the Manufacturing Industry? Are you passionate about solving complex technical problems and drive production? Are you looking for a new challenge and an exciting opportunity to drive output of a sophisticated clean-room manufacturing cell with state-of-the-art technologies in a contract medical device manufacturing environment? Do you like working in teams and developing and training people? Do you want to advance your knowledge, skills, and career in a great working environment? Would you like to have a job that rewards performance and offers competitive compensation and benefits?  

We are looking for a hardworking, disciplined, technically competent, and enthusiastic Cleanroom Manufacturing Technician to join our Cleanroom Production team and help us solve address day to day technical issues, drive production, support Engineering team for sustained improvements to manufacturing equipment and help improve technical competencies. 

ESSENTIAL DUTIES AND RESPONSIBILITIES 

Safety, Quality & Compliance: 

• Follow various safety, quality and company policies and procedures. 
• Follow established current Good Manufacturing Practices, cGMP.
• Follow Comar’s Health & Hygiene policies and procedures.
• Complete quality related activities and documentation as necessary. 
• Maintain the area with proper 5S principles (Sort, set in order, shine, standardize, sustain) 
• Report safety incidents or opportunities to improve safety in timely manner. 

Operation and Maintenance: 

• For various manufacturing equipment, such as extrusion blow molding, injection molding , automated assembly etc., set up equipment, molds, auxiliary systems and set and adjust process parameters within validated ranges, adjust extrusion dies for weight variations. 
• Perform machine startups and machine shutdowns including completion of all required activities and quality management system documentation. 
• Operate manufacturing equipment and auxiliary systems to produce product as per established safety, quality, and production standards and operating instructions. 
• Perform thorough product inspections and make appropriate decisions relative to product quality requirements. 
• Complete necessary quality and production activities an documentation using various paper or electronic systems. 
• Keep the equipment in safe, clean, and good working conditions. 
• For end- to-end manufacturing and packaging process, assist in troubleshooting and resolution of various production, quality, equipment, or documentation issues. 
• Partner with Maintenance and Engineering team in identifying and improving equipment issues. Assist in repairs and maintenance of the production equipment along with performing Preventative Maintenance tasks. 
• Work with the Team Leads and other team members to keep equipment running during breaks and callouts. 
• Work flexible shifts and overtime as needed and maintain reliable attendance. 
• May be required to provide Plant coverage during downtime events. 

BASIC QUALIFICATIONS

• High school diploma or equivalent
• 2 years related experience as a Manufacturing Production Operator III or Set Up Mechanic or similar role. 
• Computer user skills – proficient in basic computer use – able to quickly learn and efficiently use new systems. 
• Knowledge of raw materials and product quality specifications. 
• Proficient with controlled documents (Work Instructions, Forms, SOPs, Safety & Quality specifications, etc.), preventative maintenance task lists and equipment manuals which pertain to operation of equipment. 

PREFERRED QUALIFICATIONS 

• Vocational or trade school in related trade. 
• Pursuing RJG certification or similar qualification in the plastic injection molding space. 
• 2 years of experience working in a manufacturing environment using Injection or Extrusion Blow Molding mold machines. 
• Experience in ISO 13485 manufacturing environment with automated production lines. 
• Experience in plastics processing technologies (injection molding and/or extrusion blow molding) serving the packaging, pharmaceutical, and/or medical device markets.  

SKILLS AND ABILITIES 

• Self-motivated, conscientious, with a results-oriented mindset. 
• Good time management, organizational and communication skills to work independently and also in a team environment.
• Ability to read and follow verbal and written instructions; write simple correspondence. 
• Proficient with computers – Can log in to IQMS and accurately enter production data and complete production forms (batch record). 
• Basic math skills - add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, percentages, and decimals. 
• Ability to use measuring devices such as Go/No Go gauges, Calipers, Gram scales, Dial indicators, Comparator etc. 
• Ability to check critical process parameters and make adjustments as necessary. 
• Ability to speak clearly and effectively before groups of employees, customers and auditors as needed. 
• Ability to provide training on the equipment and systems to new employees 
• Ability to work in a fast-paced manufacturing environment with demonstrated ability to handle and prioritize multiple tasks and demands. 
• Strong technical aptitude, as well as analytical and problem-solving skills.
• Sound judgment - ability to work efficiently with many competing demands.
• Effectively present information in one-on-one and small group situations to customers, clients, and other employees of the organization. 

PHYSICAL DEMANDS 

• Stand and walk for most of the work shift. 
• Use hands and fingers to handle or feel; reach with hands and arms; occasionally stoop, kneel, crouch or crawl, climb or balance.
• Lift and/or move up to 45 pounds and occasionally more with assistance from equipment. 

WORK ENVIRONMENT 

• The employee is regularly exposed to moving mechanical parts.
• Manufacturing environment
• The noise level in the work environment is usually loud.
• Must follow Comar’s Health & Hygiene policies and procedures.  

Disclaimer 

This job description has been designed to indicate the general nature and level of work performed by employees within this classification.  It is not intended to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this position.  This job description is subject to change but remains in effect until superseded or cancelled in writing by Human Resources.