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 Packaging Component Engineer.

The Packaging Component Engineer supports development, qualification and implementation of primary, secondary and tertiary packaging components in the full cycle scope of product launch and life cycle management. The incumbent participates in assessment/conceptualization, development, design, specification, testing and implementation of packaging concepts.

She/he assists and/or leads package trial runs, project start-ups, manufacturing issue resolution, support for continuous improvement projects and labeling development activities.

* Responsible for all aspects of packaging component life cycle and introduction of new components through to component retirement while complying with Good Manufacturing Practices (cGMP), Standard Operating Procedures (SOPs) and Food and Drug Administration (FDA) requirements

* Provides technical Subject Matter Expert (SME) Packaging Component support for internal departments (Research and Development (R&D), Supply Chain, Marketing, QA, Quality Control (QC), Regulatory, Packaging, project teams, etc.); Collaborates closely with internal cross functional teams and external vendors and manufacturing facilities, as needed

* Responsible for all primary, secondary and tertiary packaging components including pallets and pallet patterns

* Assists with troubleshooting packaging line issues potentially related to component performance; Recognizes opportunities for continuous improvement, anticipates customer needs, identifies and implements solutions; Participates in development and implementation of packaging solutions supporting new product launches, continuous quality improvements and cost savings initiatives

* Writes and performs necessary studies to qualify packaging components; Writes and performs studies to determine operational parameters for Packaging department (i.e., torque ranges, sealing temperature ranges, induction sealer settings, etc.); Initiates and conducts shipping studies, as required

* Develops and maintains packaging specifications and standards; Analyzes existing packaging systems and recommend modifications; Designs and prototypes new packaging systems; Tests packaging systems for safety and functionality; Ensures packaging meets legal and safety standards

* Evaluates design of packaging systems and components to define needs for brand aesthetics, consumer acceptance, manufacturing capability, quality and cost requirements, sustainability guidelines, etc.; Develops detailed packaging specifications to ensure quality materials and best value for money on all packaging components used internal and by co-packers and co-manufacturers

* Manages conceptualization, development and implementation of packaging and processes including: design generation, prototype development, technical specifications, mold and machinery qualification, functionality and quality testing, and technology transfer

Requirements

REQUIREMENTS

* Bachelors degree in Engineering, Packaging or related science field and minimum 5 years package engineering, package development and/or technical support of existing packages in the pharmaceutical, biotechnology or related cGMP regulated environment.

* Current working knowledge of cGMPs in the pharmaceutical industry

* Understanding and strong working knowledge of packaging requirements in a pharmaceutical environment

* Experience supporting numerous aspects of packaging component life cycle, new component introduction to retirement, within a cGMP environment

* Familiarity and exposure to multiple packaging formats and related packaging equipment

Physical requirements

Office/manufacturing based position

Ability to use Personal Protective Equipment (PPE)

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