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 immediate opening in our Monmouth Junction Headquarters for an experienced Packaging Component Engineer.
The Packaging Component Engineer supports the development, qualification and implementation of primary, secondary and tertiary packaging components in the scope of product launch and life cycle management. She/he helps assess, develop, design, specify, test and implement packaging concepts. The incumbent is also responsible for assisting or leading package trial runs, project start-ups, resolving manufacturing issues, supporting continuous improvement projects and labeling development activities. She/he also supports batch records, change control, deviations, product complaint and Corrective Action Preventive Action (CAPA) activities working with Quality.
• Responsible for all aspects of the packaging component life cycle within a current Good Manufacturing Practices (cGMP) environment from introduction of a new component through component retirement
• Provide technical Subject Matter Expert (SME) Packaging Component support for all customers (Research and Development (R&D), Supply Chain, Marketing, Quality Assurance (QA), Quality Control (QC), Regulatory Affairs, Packaging Operations, etc.)
• Responsible for performance of all primary, secondary, and tertiary packaging components, including pallets and pallet patterns
• Assist troubleshooting packaging line issues potentially related to component performance (including potential for weekend and off-shift work). Recognize opportunities for continuous improvement, anticipate customer needs, identify, and implement solutions
• Initiates and conducts shipping studies, as required
• Writes and performs studies necessary to quality packaging components; Writes and performs studies to determine operational parameters to the packaging department (i.e., torque ranges, sealing temperature ranges, induction sealer settings, etc.)
Bachelors degree in a scientific and/or engineering discipline AND minimum 5 years relevant Packaging Development experience in a pharmaceutical or biotechnology environment.
Special knowledge or skills needed and/or licenses or certificates required
• Excellent working knowledge of cGMPs
• Excellent working knowledge of packaging related regulatory standards and guidance
· Familiarity and working knowledge of pharmaceutical packaging equipment and documentation in a cGMP regulated environment
· Working knowledge in the development and functionality of primary, secondary and tertiary packaging
Office based position with interaction to Manufacturing environment
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-DNI