Education and/ or Experience
Bachelor’s degree in Science such as Pharmacy, Engineering, Biotechnology, Chemistry, Physics or
Biology: a graduate degree such as M.Sc. or Ph.D. is recommended for advancement.
Minimum of 5 years of experience in a highly regulated industry like Pharmaceuticals and/ or Medical Devices. Experience in Pharmaceutical product lifecycle: Process Design, Process Qualification and Continued Process Verification. Experience in Cleaning Validation and Commissioning and Qualification.
SUMMARY OF POSITION
The Technical Operations (TO) Specialist applies his or her knowledge from various sciences to the pharmaceutical industry, such as materials, formulation, process, packaging, statistics, pharmacokinetics, etc. The TO Specialist is responsible for researching and developing new production processes for the site and for evaluating/ making modifications to existing manufacturing and/ or packaging systems to improve overall efficiency and profitability. Development might be basic, such as finding a new source for a material, or a more complicated applied development, such as implementing a new product or processes. If a product or process doesn’t exist, the TO Specialist may get input from others to develop something entirely new. The TO Specialist is often responsible for supervising several projects at once.
The resource is responsible to plan and execute the activities involved in the pharmaceutical product lifecycle: Process Design, Process Qualification and Continued Process Verification. The TO Specialist executes the Cleaning Validation for manufacturing and packaging equipment. Also, the TO Specialist executes the Commissioning and Qualification activities required to support the projects assigned. The business relies in the TO Specialist for technical knowledge to support the organization. The nature of this job will require quality and safety guidelines to be followed.
1. Planning, organizing, and overseeing process, production trials, product development and transfers.
2. Making improvements or modifications to new and current processes.
3. Performing risk assessment in formulation, process, and packaging operations.
4. Using design models (such as factorial) to develop formulations and manufacturing processes.
5. Generating ideas for new products and researching feasibility in terms of profitability, resource availability and compliance with regulations.
6. Recording and analyzing data to support but not limited to Annual Product Reviews, Investigations, Continuous Process Verification, other programs.
7. Presenting effectively projects, investigation, etc. results to colleagues and clients.
8. Investigating and testing new equipment or process.
9. Liaising with engineering, research, technical and/ or production staff.
10. Writing and reading technical papers, protocols, reports, reviews, and specifications.
11. Developing equipment cleaning processes for manufacturing and packaging, as well training the colleagues in the proper use of cleaning and sample procedures.
12. Promoting the effective use of troubleshooting tools within the organization.
13. Willing to work rotating shifts and/ or weekends, as required.
14. Comply with all environmental trainings, procedures, guidelines, practices, cGMP, permit conditions and internal notifications of any environmental event.
15. Perform any other job-related duties as required or that may arise in the future.
Licenses and/ or Certifications
• Licensed Pharmacist, Licensed Chemical or Professional Engineer Licensed, preferred.
The role requires, but is not limited to the following traits:
1. Writing skills to complete technical and development reports and oral communication skills such as presentations with staff in non-scientific positions in both English and Spanish.
2. Teamworking and Interpersonal skills.
3. Mathematical and communication skills.
4. Problem-solving skills, specially using Operational Excellence methodology (methodical approach) and tools is preferred.
5.Computer literate, specifically in but not bound to Microsoft Office suite, Statistical software (Minitab, Chartrunner, etc.), Trackwise, SAP. Search skills such as scientific literature and commercial technology.
6. A logical and investigative mind with excellent analytical skills to be able to come into a conclusion in an analysis.
7.Project Management skills are a plus for the function.
• Able to walk throughout the plant site, walk up flights of stairs and enter in confined spaces.
• Must be able to write on a keyboard and see a computer screen.
• Must be articulate and have good hearing.
• Able to dress in special clothing wears safety shoes and hard hat without discomfort.
• Able to use a respirator to work within the processing rooms.
• Must be able to differentiate colors and shapes.
• Must be able to carry a load while walking and working with the Production rooms.
• Mostly office area but must be able to move into manufacturing areas (production and packaging).
Some toxic material may be present in the production environment.
• Reports to: Manager, Technical Operations
• Receives Functional Guidance from: Manager, Technical Operations
• Position Reporting to this Position: None.