Location: Buena, NJ
The Packaging Engineer will support the current operations and the ongoing expansion of Teligent’s pharmaceutical manufacturing facility. This includes functional support of primary and secondary packaging, product labeling, and inspection (visual and automated), of both topical and injectable product forms.
This person will play a critical role in driving planned investments and improvements for current and future packaging operations. The Packaging Engineer will support operations during construction and transition phases for facility expansion and improvement projects. He/she will serve a key role in the selection, procurement, commissioning, qualification and validation of equipment and primary and secondary operations (including serialization).
The individual will also support new product development through the analysis and selection of packaging components, including bottles, jars and tubes for topical products, and vials and ampules for injectable products.
- Support technical activities related to new and existing product packaging, process optimization, process and equipment troubleshooting, and process validation
- Manage, analyze and identify trends in packaging operations data
- Support activities relating to change of processes, components and raw materials utilizing Change Control procedures
- Support investigations relating to packaging issues, product release performance, and/or customer complaints
- Identify packaging projects to improve yield, lower costs and improve efficiency
- Lead multiple packaging equipment upgrades, including the definition, procurement, installation and commissioning of new packaging lines for topical and injectable product forms, including automatic inspection equipment for vials and ampules
- Participate in project teams to execute project goals and assignments
- Support internal and external auditors and regulatory agencies as needed during inspections
- Provide data gathering and analysis as needed to support technical projects
- Analyze and improve material and personnel flow paths in the packaging areas of the current and expanded facility to optimize facility start-up time and effort
- Partner with Quality and Regulatory Affairs colleagues to ensure compliance with regulatory authority guidance for sterile operations
- Maximize the success rate for packaging operations by instituting programs to minimize human error, mechanical failure, contaminations, and procedural error(s)
- Manage the implementation and ongoing support of serialization operations and equipment maintenance required for all packaging lines
- Partner with Product Development and Supply Chain to identify primary and secondary packaging components for current and new topical (bottle, tube, jar; IFC; insert) and injectable (vial, ampule; IFC, blister pack; insert) products
- Support strategic plans for process and plant improvements in order to increase efficiency and manage costs
- Create new process and equipment drawings for existing processes based on specifications and standards
- Update drawings and P&ID to reflect changes to existing processes
- Responsible for trouble shooting and providing corrective action directives
- Troubleshoot process equipment and ensure utilities and equipment meet operating specifications
- Write standard operations procedures, standard test procedures, master batch records and other related GMP documents
- Maintain a safety-first approach to process development and manufacturing
- BS degree in Engineering (Electrical, Mechanical, Chemical, etc.) or Science discipline
- At least 8 years of packaging engineering, packaging development or operations experience in a pharmaceutical manufacturing environment
- Specific knowledge of cGMP, pharmaceutical manufacturing methods and engineering principles
- Experience performing and/or supporting equipment and utility qualifications and validations
- Prior experience with automatic inspection equipment for injectable products is a plus
- Understanding of engineering fundamentals
- Technical knowledge of packaging equipment and supporting utilities
- Excellent written and oral communication skills
- Ability to communicate in a proactive and solutions-focused manner, including keeping management aware of potential issues
- Basic computer knowledge, including Microsoft Word and Excel
- Communicate effectively with ability to function in a team environment
- Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
- Detail oriented with the ability to troubleshoot and resolve equipment problems.
- Proficient in reading schematics, diagrams, P&ID’s and other written materials
- High level of safety awareness
- While performing the duties of this job, the employee is regularly required to stand. The employee is frequently required to walk; sit; use hands; talk; and hear. The employee is occasionally required to reach with hands and arms; climb or balance; stoop; kneel; crouch. The employee must occasionally lift and or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, and color vision.
- The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs.