Manufacturing Operation Specialist- Non- Standard Shift

fitspr; Juncos (PR); On-site; USD 70,000 - 100,000; Full time

Job summary

FITS is seeking a scientist for our Manufacturing Services—Inspection and Vial Packaging area. The role requires a Bachelor's degree and 5+ years in pharmaceutical or regulated environments, with English and Spanish fluency and strong project management skills.

The candidate will partner with manufacturing operators and manage document control in a fast-paced lab setting. Responsibilities include authoring and approving procedures, monitoring process performance, troubleshooting, and developing

Qualifications

• Bachelor's degree with 5+ years as a Scientist in pharma or regulated environments.
• Fluency in English and Spanish.
• Project management skills and shift flexibility.

Responsibilities

• Initiate, revise, and approve manufacturing procedures; own documents.
• Assess process performance via floor observations and data review; plan solutions.
• Provide troubleshooting support for manufacturing operations.
• Assist in creating training materials and delivering training on processes.
• Support establishment of process monitoring parameters and control limits; collect data.
• Ensure timely execution of quarterly process monitoring reports and NC/CAPA closure.
• Author investigation reports and execute corrective actions.
• Review root cause analyses and support trend evaluations.

Skills

Bilingual English/Spanish

Project management

Manufacturing operations

Document management

Operator collaboration

Education

Bachelor's degree in science

Job description

For Manufacturing Services in the Inspection and Vials Packaging area.

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelor'sDegree with five (5)years of experience asa Scientistwithin the pharmaceutical or regulated industry.
• Bilingual (English & Spanish).
• Project Management skills.
• Shift: Non-Standardsand according to business needs.
• Experience in:
  • Manufacturing Operation.
  • Document Management, create new documents, review and approval of documents.
  • Work with manufacturing operators.

The Personality Part:

• Picture yourself in a lab with all the equipment you need to put your multitasking, scientific, creative (to come up with all those experiments!) skills to work. Picture as well an environment of healthy competition, teamwork, being ethical and of using the 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)

• Initiate, revise, and approve manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner.
• Assess process performance by observation of floor operations and review of performance data. Evaluate, plan, and implement solutions.
• Provide troubleshooting support.
• Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process.
• Support establishment of process monitoring parameters and control limits. Collect process-monitoring data and support the assessment of deviations.
• Provide support of timely execution of the process monitoring quarterly reports.
• Ensure that all Non-conformances are triaged within the established goal.
• Responsible for authoring investigation reports.
• Responsible for execution of corrective actions.
• Responsible for managing NC/CAPA closure within established goal.
• Monitor and communicate incidents trends.
• Review equipment/system Root Cause Analysis investigations and support trend evaluations.

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?