Qualification Engineer

Description

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)
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