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 addressing 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 our team members 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. We believe in each other and in respectful, open and honest communications to help support individual and team success.

We have an opening in our Monmouth Junction, NJ facility for an experienced Technical Services (TS) Engineer I.

The TS Engineer I provides direct validation support to pharmaceutical development and manufacturing operations. The incumbent performs both routine and more complex validation activities accurately and completes appropriate documentation fully and compliantly in accordance with current Good Manufacturing Practices (cGMPs), Standard Operating Procedures (SOPs) and Food and Drug Administration (FDA) requirements.

* Responsible for assigned aspects of Technical Services activities while complying with cGMPs, SOPs and FDA requirements

* Responsible for executing TS, Cleaning Validation and Process Validation testing and studies for existing products modified processes; Compiles accompanying study test data to assist and support Scientists in determining processes have met approved and expected validation criteria

* Compiles Critical Quality Attributes (CQA) data on commercial batches for Annual Product Review (APR) and for continues process verification activities and reports; Performs verifications of complied data and other document verification activities, as needed

* Reviews cGMP documents for updates required for Change Control document addendums

* Collaborates with, and assists, Equipment Qualification Engineers on required equipment qualification activities, as needed

* Generates placebo batch records and performs Performance Qualifications (PQ) studies for Equipment Qualifications

* Performs and assists with other Validation tasks and activities as instructed by TS Engineers and/or management

* Adheres to all plant safety policies and procedures

Requirements

Special knowledge or skills needed and/or licenses or certifications required

Bachelors degree in science or technology related field (Engineering, Chemistry, Pharmacy, etc.) and minimum 2 years experience in a validation, technical services, manufacturing operations, product development or related field in a pharmaceutical or biotechnology related industry OR Masters degree in science or technology related discipline (Engineering, Chemistry, Pharmacy, Biology, etc.) and minimum 1 year experience in a validation, technical services, manufacturing operations, product development or related field in a pharmaceutical or biotechnology related industry

* Exposure to Technical Service /Product Development, Formulation, Process Validation and/or Cleaning Validation through pharmaceutical or biotechnology industry experience REQUIRED

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

* Current working knowledge of cGMPs in the pharmaceutical industry REQUIRED

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

Physical requirements

Office/Manufacturing based position

Ability to use Personal Protective Equipment (PPE)

Ability to stand for extended periods

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-onsite