The Senior Packaging Engineer is responsible for a portfolio of primary and secondary packaging projects to support Novan's formulation, development, and manufacturing group. This position will also be responsible for directing the applicable testing associated with the packaging projects. This position shall adhere to the Company's quality system including but not limited to the applicable standards, policies and procedures in the areas of responsibility defined in this job description.
Principal Responsibilities and Accountabilities:
- Perform duties on site, on-time, and within the Company's normal business hours listed in the Employee Handbook. Facilitate frequent interactions with co-workers and Novan CMOs and conduct timely problem-solving meetings necessary to address critical and emerging issues. Present a positive attitude to create and maintain productive working relationships with fellow employees and vendors.
- Provide technical input in packaging development projects to ensure products are delivered to patients in the most compliant manner.
- Work across functions and interact effectively with teams in analytical, quality assurance, regulatory, clinical and marketing.
- Provide technical recommendations and implement changes for packaging processes and materials.
- Responsible for interaction with external CMO packaging operations.
- Collaborate with other groups within Novan to ensure project timelines are met.
- Communicate results in a timely and precise manner.
- Design experiments and interpret data to support regulatory submissions.
- Knowledge of cGMPs and associated regulatory considerations in a commercial pharmaceutical packaging environment.
- Perform other duties as assigned.
- BS or MS degree in a scientific, engineering or related discipline
- BS with 20+ years of relevant work experience in the pharmaceutical industry or MS with 10+ years of experience.
- Supervisory experience preferred.
- Strong working knowledge of pharmaceutical industry knowledge of regulatory requirements.
- A thorough understanding of cGMPs as they apply to pharmaceutical manufacturing and packaging is required
- Demonstrated experience with analytical testing associated with packaging systems.
- A thorough knowledge of pharmaceutical container/closure systems including the materials of construction.
- Ability to work effectively and comfortably in multi-disciplinary teams, identify appropriate resources needed, and develop schedules to ensure the timely completion of high-quality projects within budget.
- Excellent written and verbal communication skills and ability to communicate and present results and ideas to upper level management in a clear, concise, and timely manner.
- With minimal guidance, must handle multiple responsibilities, priorities, tasks, and projects simultaneously with a positive, can-do attitude.
- Strong organizational skills and attention to detail and accuracy
- Excellent analytical skills.
- Self-motivated team player, strategic thinker, persistent, tactful, and persuasive.
- Strong computer skills with proficiency using MS Office software Excel, Word, and PowerPoint are required.
Physical Demands and Work Environment:
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.
In the typical office environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, use hands and fingers (i.e. typing) and occasional lifting up to 20 pounds. There will be an occasional requirement to work outside of normal business hours. Some travel may be required.
The typical laboratory and manufacturing environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, use of hands and fingers (i.e. sample preparation and instrument operation) and occasional lifting up to 40 pounds. Safe handling, use, and disposal of chemicals and other hazardous materials are required.
Novan, Inc. maintains a drug-free workplace and performs pre-employment and employment substance abuse testing and background verification checks.
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