Process Development Scientist- 34630

Summary:

To conceive, design, implement and execute specific scientific experiments, which contribute to the successful completion of goals and/or projects under general guidance of supervisor.

Functions:

• Conceives and designs, executes or evaluates, and interprets experimental strategies.
• Provides input to new processes to generate robust and reliable data.
• Ensures that studies are conducted in compliance with the respective protocol and applicable guidelines and regulations.
• Designs, monitors or conducts experimental strategies with general guidance from supervisor.
• Provides data analysis and interpretation, and assesses impact of the data on the project.
• Keeps current in field of scientific expertise and areas relevant to their function.
• Monitors field of expertise, including literature and technology development, and communicates relevant observations.
• May introduce advanced scientific methods.
• Develops and implements new and novel protocols to address specific issues.
• May represent the department on project teams under supervision of a senior scientific staff member.
• May initiate productive collaborations within and outside of the department or company.
• Advises or assists others in experimental design and/or interpretation/diagnosis of data and implementing innovative remedies.
• Independently authors scientific reports, summary documents, complex regulatory documents, invention disclosure submissions and/or patents.
• Participates in external scientific community.
• May assume lead role in department-wide support efforts such as safety, recruiting and committees.
• May develop supervisory and mentoring skills.
• Develops and follows timelines for completing project team work.

Education:

• Masters + 2 years of Scientific experience.
• Bachelors + 4 years of Scientific experience.

Preferred Qualifications:

• Provide direct support to the requirement, design, and characterization of inspection/packaging process, process optimization strategies and/or troubleshooting of operational issues in the operations.
• Apply advanced and diverse engineering principles to the design and implementation of system, equipment or process modifications, experiments, process and/or capital projects.
• Develop, organize, analyze and present interpretation of results for operational issues or engineering projects.
• Requirements:
• 1. Provide advanced technical support to AML-1 automatic packaging equipment and processes
• Strong Knowledge on Vision system technologies

Inspection/packaging Concepts Knowledge

• Strong Knowledge with local process flow, layouts and general packaging SOP’s to be able to define details of serialization solution.

1. 2. Support troubleshooting, investigations, root cause analysis related to the packaging area and inspection process. 3. Identify and implement initiatives in the inspection/packaging processes in order to reduce manufacturing operational costs while maintaining product quality 4. Development and Execution of Processes Characterization
2. 5. Project execution activities coordination (Material requests, Trainings, Production Windows, Work Orders generation) 6. General skills:

Establish Testing Strategies

• Design / Development of Characterization Protocols

Technical Reports Development

• Validations, and technical reports- To support SATs executions, document generation and challenge validations strategies.
• Risk assessments and QRAES knowledge, to support risk assessments activities.
• Technical Documentation abilities Oral and written.
• Documentation software (MS word, Excel, Power point, PDF, Visio, MS project).
• Project management basic concepts (timeline follow up, schedule reviews, predecessor).
• Flexibility in working time based on project needs, including 1st, 2nd and 3th shifts and extended. hours up to 12 hrs.
• People skills for OEM’s and interdisciplinary share.
• Self driven and schedule oriented.

Skills:

• Advanced scientific analysis and troubleshooting skills. Advanced laboratory work skills.
• Ability to motivate and/or supervise the activities of others.
• Must be well organized, have multi-task project experience, and be able to communicate and work well with other departments.
• Must have demonstrated skills and competencies in the following areas: Verbal communication, Written communication including technical writing skills, negotiation and conflict resolution. Analytical problem solving Project management.
• Ability to be flexible and manage change.
• Computer literacy (Windows environment: Word, Excel, Power Point).
• Skills requiring the application of scientific theory.
• Creative skills in the design and performance of scientific experiments and interpretation of results.
• Strong knowledge of cGMP
• Fully bilingual (English/Spanish).

Work Methodology:

100% Onsite

• 6 months (1st Contract)
• Administrative Shift (weekends and overtime may also be required).

Professional Service Contract