Packaging Technician Lead

Packaging Technician Lead

Tris Pharma, Inc. 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.

This position is temporary to potential hire opportunity, based on company needs and successful performance.

Located in Monmouth Junction, NJ, Tris has immediate openings for (2) Packaging Technician Leads for 2nd SHIFT. Shift is 4 days/week for 10 hrs. Mon-Thurs, Hours are 3:00 pm 1:00 am.

The Packaging Technician Lead is responsible for supporting and assisting in the packaging of a range of pharmaceutical products in accordance with Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs), Food and Drug Administration (FDA) standards and batch record specifications. She/he operates, sets-up, and maintains various pharmaceutical packaging equipment as assigned, and thoroughly and accurately documents all activities to ensure compliance with regulatory guidelines.

The incumbent collaborates closely with the Supervisor, Packaging and may be asked to perform many senior and supervisory packaging functions/initiatives in the supervisor's absence including, but not limited to coordination of daily packaging activities and supervision of safety and workflow, etc.

Essential Functions

Primary duties/responsibilities

• Supports and assists in the packaging of pharmaceutical products according to SOPs, cGMPs, FDA standards and batch record specifications
• Performs the day to day activities of the packaging process as assigned; Operates various types of Packaging equipment including, but not limited to: fillers, cappers, labelers, cartoners, bundlers, shrink wrappers, etc. to ensure efficient packaging of goods
• Assists in set up, change over and test runs of equipment for various sized batches and various products, as needed
• Collaborates with other production staff and departments
• Accurately and consistently completes and documents batch records and other required paperwork
• Precisely follows work orders and specifications
• Adheres to all plant safety policies and procedures
• Assists with organization of daily schedule and assigns personnel to the various workspaces to meet the demand of planning
• Reports and investigates any deviations from processes or procedures
• Maintains a presence on the packaging floor at all times, Trains new employees and mentors lower-level technicians, as appropriate
• May assist with the development and writing of SOPs and investigation reports and contributes to the circulation of the documents under approved procedures
• Assists in maintaining a safe and clean work environment by educating and directing personnel on the use of all control points, equipment, and resources, maintaining compliance with established policies and procedures
• Works extra hours or weekends as required by management to meet the demands of the schedule

Requirements

High school diploma or equivalent REQUIRED

Ability and willingness to learn manufacturing procedures and federal regulations pertaining to manufacturing processes REQUIRED

Demonstrated ability to read and interpret documents such as safety and environmental policies, operating and maintenance instructions and procedure manuals, etc. REQUIRED

Strong record keeping skills/ability REQUIRED

Excellent verbal and written communication and skills REQUIRED

Minimum education and years of relevant work experience

High school diploma or equivalent AND minimum 5 years experience working in a pharmaceutical or biotechnology cGMP regulated environment.

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

Working knowledge of manufacturing procedures and federal regulations pertaining to manufacturing processes

Working knowledge of good manufacturing systems and familiarity with regulatory and manufacturing SOPs and cGMPs

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

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 excellent 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)

Ability and willingness to work additional hours as required by business needs

Special knowledge or skills needed and/or licenses or certificates preferred

• Solid dose manufacturing experience
• Associates degree or some college coursework

Travel requirements

0%

Physical requirements

Manufacturing based position

Ability to lift up to 50 lbs

Ability to use Personal Protective Equipment (PPE)

Ability to stand for extended periods

Anticipated pay rate: $23-28/hour. There is an additional $1.50 per hour for the shift differential.

Pay rate offered is contingent on assessment of candidate's education and experience level relative to requirements of the position and a review of related industry standards and internal equity.

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.