Qualification Engineer

Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned biopharmaceutical company in the U.S. with a focus on development and commercialization of innovative medicines that address unmet patient needs. We have more than 150 US and International patents including applications and have marketed several branded and generic products in the U.S., have licensed our products in the US and international markets, and 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 it is our team members that set us apart; they are the engine that fuels Tris’ passion and innovation. Tris colleagues understand the criticality of operating a successful business and take pride in the company’s success. But of equal importance to each member of the team is how we interact with one another on a daily basis. We believe in each other, and we believe in respectful, open and honest communications to help support individual and team success. 

Our Facilities & Engineering Department located in Monmouth Junction, NJ has an immediate need for an experienced Qualification Engineer.

SUMMARY

The Qualification Engineer supports and assists the Facilities & Engineering department with writing and execution of various qualification protocols for production and critical utilities equipment to meet production requirements including deadlines and compliance in accordance with Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs) and Food and Drug Administration (FDA) requirements. 

ESSENTIAL FUNCTIONS 

Primary duties/responsibilities

• Responsible for Qualification Engineering activities, including      writing protocols and reports complying with cGMPs, SOPs and FDA      requirements
• Responsible for supporting and assisting Engineering qualification      function by providing documented evidence all company equipment is      qualified and remains in a state of control to deliver processes and      products complying to all regulatory and business specifications
• Provides Engineering support and collaborates cross functionally      with Operations, Packaging and      Manufacturing departments on appropriate qualification, programming and      troubleshooting issues 
• Responsible for design, writing and executing qualification      protocols, tests and reports including, but not limited to: Installation Qualification (IQ),      Operational Qualification (OQ) and Performance Qualification (PQ) for production      equipment based on user, quality, technical and functional requirements
• Responsible for organizing and maintaining the Engineering File      Library.
• Creates and revises SOPs, as needed
• Maintains Laboratory, Manufacturing and Packaging equipment      validation schedules, testing and developmental roll-outs
• Prepares appropriate Change Controls and performs associated tasks      in an accurate, timely, effective and compliant manner

Requirements

KNOWLEDGE/SKILLS/ABILITIES REQUIRED

· Bachelors degree in Engineering and minimum 3 years Qualification, Validation and/or related experience in the pharmaceutical or biotechnology industry

· Working knowledge of good manufacturing systems and familiarity with regulatory and manufacturing SOPs and cGMPs

· Hands on experience working with qualification protocols (i.e., IQ, OQ, PQ)

· Demonstrated ability to read and interpret documents such as safety and environmental policies, operating and maintenance instructions and procedure manuals, etc.

· Proficiency with Microsoft Office, including Project 

· 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 problem-solving skills and the ability to adapt to changing priorities and deadlines

· Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects

· Fluent in English (verbal and written) 

Physical requirements

Manufacturing based position

Ability to use Personal Protective Equipment (PPE)