Description:

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. 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 teamwork.

Education

Doctorate degree or Master’s degree and 5 years of Scientific experience or Bachelor’s degree and 6 years of Scientific experience.

Competencies/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 cGMPs. Fully bilingual (English/Spanish).

What attributes (i.e. - preferred qualifications) would make this candidate stand out?

Technical Skills:

• Basic Knowledge, experience, or understanding with several of the following skills:

o Vision systems and Vision Tools (Cognex, Systech, Optel, Keyence, EISAI/BOSH/Syntengon, Seidenader, Brevetti, MvTech)

o Analog and digital cameras technology

o Camera Systems illumination, lenses, and frame grabbers settings

o Artificial Intelligence and Deep Learning

o PLC controls programming (Rockwell Automation / Allen Bradley (SLC500, PLC5, MicroLogix, Compact Logix and Control Logix), Siemens Simatic/TIA, B&R)

o Programming languages (Microsoft Visual Basic, .Net, Visual C#, Python, JScript, VBScript)

o Industry standards for software development life cycle methodologies, 21 CFR Part 11, and GAMP

• Experience in Tech Transfer, Process Design, Commissioning & Qualification

• Participation and/or development of Design, installation, and validation of automated processes (URS, SDS, HDS, P&IDs, FS, IQ, OQ, VSR, SOP's)

• Preferred experience on Automation process and/or Vision Inspection systems development

• General Skills

o Excellent communication skills: oral and written. Interacts effectively with variety of communication and working styles.

o Fully bilingual in Spanish and English

o Demonstrated strong problem solving and conflict resolution

o Demonstrated leadership skills, initiative, and self-motivation.

o Time and project management skills to deliver projects on time and budget.

o Great teammate with negotiation skills to work with multidisciplinary teams that relies on collaboration for effective decision-making

o High quality and compliance mind set to work in a highly regulated GMP industry.

o Computer literacy (Windows environment: Word, Excel, Power Point, Minitab)

1. Development and Execution of Processes Characterization (Packaging and Vision System preferred)

a. Establish Testing Strategies

b. Design / Development of Characterization Protocols

c. Technical Reports Development

d. Validations, and technical reports- To support SATs/IOQ/PQ executions, document generation and challenge validations strategies.

e. Risk assessments and QRAES knowledge, to support risk assessments activities.