TS Engineer I

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.

We have an opening for a Technical Services Engineer to work in our Monmouth Junction, NJ facility. 

This is an Office and Manufacturing based position. 

This is a 1st shift position but requires the flexibility to work periodically on 2nd or 3rd shift for short periods based on validation project needs.

• Responsible for all aspects of validation activities, including writing protocols and reports, complying with Good Manufacturing Practices (CGMP), Standard Operating Procedures (SOP) and Food and Drug Administration (FDA) requirements

• Compiles study test data to help senior TS Scientist/Engineers to determine that processes have met validation criteria.

• Compiles CQA data on commercial batches for Annual product review and for continued process verification activities

• Performs verifications of compiled data and other document verification activity

• Red-lines GMP documents for updates that are required to be attached to Change Control Documents

• Teams up with Equipment Qualification Engineers for Equipment Qualification Activities

• Generates Placebo batch records for analytical studies and perform PQ studies for Equipment Qualifications

• Prepares Change Controls and performs tasks associated with the Change Control.

• Understands the operation of equipment and production processes within Manufacturing

• Aids Manufacturing and Packaging in troubleshooting, problem solving and product impact analysis and assisting in drafting investigations/CAPAs/CPIs

• Aids Manufacturing in the Training of Operators and associate level Technical Services team members.

QUALIFICATIONS 

Bachelors or Masters in Engineering, Chemistry, Pharmaceutical Science AND 2-5 years of pharmaceutical experience in a pharmaceutical or Biotechnology industry REQUIRED

· Exposure and current working knowledge of Technical Services/Product Development, Formulation, Process Validation and/or Cleaning Validation through pharmaceutical or biotechnology industry experience or academic practical studies REQUIRED

· Strong understanding and/or exposure in the operation of manufacturing equipment within production of solid and/or liquid oral dosage forms (tablet press, granulator, fluid bed processor etc.) REQUIRED

· Current working knowledge of cGMPs in the pharmaceutical industry REQUIRED

· Fluent in Microsoft Word, Excel, Visio and Project REQUIRED

· Fluent in Statistics and Statistical Analysis Software Packages (Minitab, Jump, etc.) REQUIRED

· Experience within a Technical Service and/or Validation department A PLUS 

Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer. #LI-DNI PM22