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Engineering - Senior Packaging Technology Specialist
Manati, PR · Biotech/PharmaceuticalSummary/Overview of this role:
Providing support to the packaging engineering activities related to new package development, packaging product transfer and packaging operational support of Sterile/Biologics products
Responsibilities:
1. Responsible of providing support to the packaging engineering activities related to new package development, packaging product transfer and packaging operational support of Sterile/Biologics products.
2. Responsibilities include the Interaction and support using the BMS standard packaging documentation change control system.
3. This position must comply with all security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function.
Example:
- Experience writing test procedures, packaging machinery specifications, performs line trials and troubleshooting, (works with packaging machinery vendors, etc.)
- Experience in coordinates packaging validation and line trial activities with local validation, production, engineering, planning and quality groups as needed.
- Experience supporting new packaging technology and product transfers.
- Ensures that equipment's are capable of handling all current packaging components and will determine whether it can support proposed changes in packaging components.
4. Supports, assists and /or justifies packaging capital projects help research.
5. Plans, coordinates, and executes projects to assure achievement of site’s departmental and company goals and objectives. Manage project timetables for new and ongoing projects. Provide project status through the use of project plans, presentations, or written reports.
6. Provides troubleshooting packaging equipment, executing packaging equipment trials and systems with the knowledge to modify and recommend changes to equipment's and components as needed.
7. Provides assistance and technical support to packaging projects for products manufactured at the pharmaceutical manufacturing site. The support includes equipment used in the packaging of Oral solid products with more emphasis on Parenteral packaging.
8. Reviews and approves component specifications in compliance with applicable regulations and the internal policies and procedures.
Education Required:
• Bachelor Degree in Sciences or Engineering ( Mechanical, Electrical or Computer) with more than five (5) years or Relevant associate or Associate Degree with more than ten (10) years in the Pharmaceutical Industry (Parenteral Manufacturing/Packaging Operations)
Experience Required:
• Strong background on Parenteral Packaging processes is required with device assembly experience preferred.
More than five to ten (5-10) years in the Pharmaceutical Industry (Parenteral Manufacturing/Packaging Operations)
• Strong background on packaging equipment qualification or equipment (in general).
• Excellent technical writing/oral communication skills (English/Spanish).
• Flexible to work extended hours when required.
• Computer Proficiency: MS Office, MS Excel, MS Project
• Technical knowledge in pharmaceutical manufacturing processes, technologies and processing equipment – Sterile Packaging, and Processes.
• Capability for providing hands-on support for equipment, materials and process troubleshooting.
• Knowledge of process improvement and troubleshooting
• Time management, planning and organization capabilities
• Project management skill
• Knowledge of cGMP's, OSHA and FDA Regulations
• Problem-solving skills
***** Please note: THIS IS NOT AN EQUIPMENT VALIDATION POSITION ***
**Weil Group is proud to be an Equal Employment Opportunity Employer.**
Providing support to the packaging engineering activities related to new package development, packaging product transfer and packaging operational support of Sterile/Biologics products
Responsibilities:
1. Responsible of providing support to the packaging engineering activities related to new package development, packaging product transfer and packaging operational support of Sterile/Biologics products.
2. Responsibilities include the Interaction and support using the BMS standard packaging documentation change control system.
3. This position must comply with all security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function.
Example:
- Experience writing test procedures, packaging machinery specifications, performs line trials and troubleshooting, (works with packaging machinery vendors, etc.)
- Experience in coordinates packaging validation and line trial activities with local validation, production, engineering, planning and quality groups as needed.
- Experience supporting new packaging technology and product transfers.
- Ensures that equipment's are capable of handling all current packaging components and will determine whether it can support proposed changes in packaging components.
4. Supports, assists and /or justifies packaging capital projects help research.
5. Plans, coordinates, and executes projects to assure achievement of site’s departmental and company goals and objectives. Manage project timetables for new and ongoing projects. Provide project status through the use of project plans, presentations, or written reports.
6. Provides troubleshooting packaging equipment, executing packaging equipment trials and systems with the knowledge to modify and recommend changes to equipment's and components as needed.
7. Provides assistance and technical support to packaging projects for products manufactured at the pharmaceutical manufacturing site. The support includes equipment used in the packaging of Oral solid products with more emphasis on Parenteral packaging.
8. Reviews and approves component specifications in compliance with applicable regulations and the internal policies and procedures.
Education Required:
• Bachelor Degree in Sciences or Engineering ( Mechanical, Electrical or Computer) with more than five (5) years or Relevant associate or Associate Degree with more than ten (10) years in the Pharmaceutical Industry (Parenteral Manufacturing/Packaging Operations)
Experience Required:
• Strong background on Parenteral Packaging processes is required with device assembly experience preferred.
More than five to ten (5-10) years in the Pharmaceutical Industry (Parenteral Manufacturing/Packaging Operations)
• Strong background on packaging equipment qualification or equipment (in general).
• Excellent technical writing/oral communication skills (English/Spanish).
• Flexible to work extended hours when required.
• Computer Proficiency: MS Office, MS Excel, MS Project
• Technical knowledge in pharmaceutical manufacturing processes, technologies and processing equipment – Sterile Packaging, and Processes.
• Capability for providing hands-on support for equipment, materials and process troubleshooting.
• Knowledge of process improvement and troubleshooting
• Time management, planning and organization capabilities
• Project management skill
• Knowledge of cGMP's, OSHA and FDA Regulations
• Problem-solving skills
***** Please note: THIS IS NOT AN EQUIPMENT VALIDATION POSITION ***
**Weil Group is proud to be an Equal Employment Opportunity Employer.**