Process Development Scientist -05

FITS LLC; Juncos (PR); On-site; USD 65,000 - 90,000; Full time

Job summary

FITS LLC is seeking a Scientist Services professional for our Process Development: Inspection Projects area in Puerto Rico. The role requires a Bachelor’s degree with four years of experience in pharma, bilingual English/Spanish, and project management skills.

You will work on automated and manual visual inspection, QC of packaging components, GMP line clearance, and data collection in the Process Development Lab.

Qualifications

• Bachelor's degree with four years of experience as a Scientist within the pharmaceutical or regulated industry.
• Bilingual in English and Spanish.
• Project management skills.
• Experience in automated and manual visual inspection of finished drug products.
• Experience with primary packaging components incoming quality inspection (vials, stoppers, caps, syringes).
• GMP packaging line clearance, verification, and in-process controls.
• Process development laboratory sample testing and data collection.

Responsibilities

• Conceives, designs, executes, 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 the supervisor.
• Provides data analysis and interpretation and assesses the impact of the data on the project.
• Keeps current in the 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 the 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 implements innovative remedies.
• Independently authors scientific reports, summary documents, complex regulatory documents, invention disclosure submissions, and/or patents.
• Participates in the external scientific community.
• May assume a 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.

Skills

Bilingual (English & Spanish)

Project Management

Education

Bachelor's Degree

Job description

For Scientist Services in the Process Development:Inspection Projects area.

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelor'sDegree with four(4)years of experience asa Scientistwithin the pharmaceutical or regulated industry.
• Bilingual (English & Spanish).
• Project Management skills.
• Shift: Administrative, and according to business needs.
• Experience in:
  • Automated & Manual Visual Inspection of Finished Drug Products.
  • Primary Packaging Components Incoming Quality Inspection (Vials, Stoppers, Caps, Syringes).
  • GMP Packaging Line Clearance, Verification, and In-Process Controls.
  • Process Development Laboratory Sample Testing and Data Collection.

The Personality Part:

• Picture yourself in a lab… with all the equipment you need to put your multitasking, scientific, and creative (forcomingup with all those experiments!) skills to work. Picture as well an environment of healthy competition, teamwork,ethical behavior, and the use ofthe scientific method in all ways possible. If you like how this sounds, then this might be the job for you. Bring it on!

AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)

• Conceives, designs, executes, 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 the supervisor.
• Provides data analysis and interpretationand assesses the impact of the data on the project.
• Keeps current in the 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 the 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 implements innovative remedies.
• Independently authors scientific reports, summary documents, complex regulatory documents, invention disclosure submissions, and/or patents.
• Participates in the external scientific community.
• May assume a 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.

WHO WE ARE:

We are a Service Provider companydifferent from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industryclients with top-notch quality talent.We're FITS!

Are you the next piece?