Facilities Maintenance Mechanic

Tris Pharma, Inc. () is a leading privately-owned U.S. biopharmaceutical company with a focus on development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction addressing unmet patient needs. We have >150 US and International patents and market several branded ADHD products in the U.S. We also license our products in the US and ex-US markets. We have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology.

Our science and technology make us unique, but our team members set us apart; they are the engine fueling Tris’ passion and innovation. Our colleagues understand the criticality of operating a successful business and take pride in the company’s success. Equally importance to each team member is how we interact with one another on a daily basis. We believe in each other and in respectful, open and honest communications to help support individual and team success.

Our Facilities-Manufacturing Maintenance Department is growing, and we have openings for Manufacturing Maintenance Mechanics at various levels, requiring various levels of experience, at our Monmouth Junction, NJ facility.

Hours:

Monday-Friday, 7:00 AM – 3:30 PM

Title and salary commensurate with experience. (See below)

• Responsible for all aspects of Facilities and Production equipment maintenance while complying with cGMPs, SOPs and FDA requirements
• Performs routine and complex work related to the troubleshooting, repair and upgrade of manufacturing equipment;
  Responsible for preventive maintenance (PM), repair and continuous improvement of facilities and manufacturing equipment
• Assists in performing Root Cause Analysis on equipment failures to support investigations
• Precisely follows work orders and specifications
• Adheres to all plant safety policies and procedures
• Higher level Mechanics:
  Trains new employees and mentors lower-level mechanics, as appropriate
• Assists in maintaining a safe and clean work environment by educating and directing personnel on the use of all control points, equipment and resources;
  Maintains compliance with established policies and procedures

• Minimum Education And Years Of Relevant Work Experience
  • Mechanic I:
    High school diploma or equivalent AND minimum 3 years experience as a maintenance/mechanic or related specialty working in a cGMP regulated environment in a pharmaceutical or biotechnology facilities, consumer products, packaging and/or manufacturing department(s)
  • Mechanic II:
    High school diploma or equivalent AND minimum 5 years experience as a maintenance/mechanic or related specialty working in a cGMP regulated environment in a pharmaceutical or biotechnology facilities, consumer products, packaging and/or manufacturing department(s)
  • Mechanic III:
    High school diploma or equivalent AND minimum 7 years experience as a maintenance/mechanic or related specialty working in a cGMP regulated environment in a pharmaceutical or biotechnology facilities, consumer products, packaging and/or manufacturing department(s)
• Special knowledge or skills needed and/or licenses or certificates REQUIRED
  • Working knowledge of manufacturing procedures and federal regulations pertaining to manufacturing processes
  • Working knowledge of good manufacturing systems and familiarity with regulatory and manufacturing SOPs and cGMPs
  • Hands on, working knowledge of Facilities and Production equipment and Production processes
  • Hands on, working knowledge of electrical, pneumatic and hydraulic systems
  • Demonstrated ability to read and interpret documents such as safety and environmental policies, operating and maintenance instructions and procedure manuals, etc.
  • Excellent verbal and written communication and skills
  • Ability to work independently and collaboratively, as required, in a fast paced, matrixed, team environment consisting of internal and external team members
  • Analytical thinking with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
  • Excellent planning, organization and time management skills including the ability to…