Tris Pharma, Inc. (www.trispharma.com) is a rapidly growing, technology-driven pharmaceutical company engaged in branded and generic product development. Located in Monmouth Junction, NJ, Tris has immediate openings for a Packaging Technician Lead for 2nd SHIFT. Shift is 4 days/week for 10 hrs. Hours are 3:00 pm – 1:00 am.

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

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

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.