Change Control & Project Execution
Lead and document specification changes, ensuring proper approvals and compliance.
Coordinate updates with clients, including drug application holders.
Support packaging-related projects, implementing changes to meet project goals.
Manage documentation, validation, and execution of packaging modifications.
Ensure all changes align with regulatory (GMP/serialization) requirements.
Technical Support & Process Optimization
Serve as SME for packaging systems and serialization processes.
Troubleshoot packaging and equipment issues to minimize production disruptions.
Analyze production needs and constraints to recommend practical solutions.
Collaborate with operations to improve packaging line efficiency and performance.
Provide technical support for product-specific packaging challenges.
Cross-Functional Collaboration & Training
Act as liaison between clients, operations, and internal stakeholders.
Communicate technical requirements and project updates clearly across teams.
Train team members on packaging systems, processes, and best practices.
Support continuous improvement initiatives to enhance quality and efficiency.
Contribute to a collaborative, solution-oriented team environment.
Qualifications
At least one year of work in a Pharmaceutical cGMP environment is required for consideration.
Bachelor's degree in Engineering (Mechanical, Chemical, Industrial, Electrical, or related engineering discipline) required.
2+ years of pharmaceutical experience.
Experience in a pharmaceutical cGMP manufacturing, packaging, OSD, or sterile setting required.
Knowledge, Skills, and Abilities
Strong analytical and problem-solving skills. Ability to analyze data, identify problems, and develop solutions.
Understanding of manufacturing processes and systems. Knowledge of various manufacturing technologies and equipment.
Effective communication and interpersonal skills. Ability to work effectively with teams, communicate technical information clearly, and collaborate with stakeholders.
Project management skills. Ability to plan, organize, and manage projects effectively.
Familiarity with safety regulations and procedures. Understanding of relevant safety regulations and best practices.
Physical Demands and Work Environment
The physical demands and work environment 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. While performing the duties of this Job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to sit. The employee is occasionally required to stand; walk and stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
While performing the duties of this job, the employee is frequently exposed to moving mechanical parts, fumes, or airborne particles and toxic or caustic chemicals. The employee is occasionally exposed to wet and/or humid conditions; high, precarious places, risk of electrical shock and vibration. The noise level in the work environment is usually moderate. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to safety eyewear, hearing protection, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc. Other tasks involving elevated work may require the use of a body harness and lanyard. Additionally, the employee may be required to operate an industrial vehicle.
