Title: Process Development Scientist (3485823)

Location: Puerto Rico (Open to Puerto Rico residents who are U.S. Citizens)

Work Model: 100% Onsite – Administrative Shift

Positions: 1

Contract Duration: Approximately 7 months

Summary

Our client is seeking a Process Development Scientist responsible for conceiving, designing, implementing, and executing scientific experiments that support the successful completion of project and organizational goals under general supervision.

Preferred Qualifications

• Direct support for inspection/packaging process requirements, design, and characterization.
• Experience with process optimization strategies and troubleshooting operational issues.
• Application of advanced engineering principles to process, system, or equipment modifications and experimentation.
• Ability to develop, organize, analyze, and present technical results for operational and engineering initiatives.

Requirements

1. Technical Support

• Provide advanced support to automatic packaging equipment and processes.
• Strong knowledge of:
• Vision system technologies
• Inspection/packaging concepts
• Local process flows, layouts, and packaging SOPs (to define serialization solution details)

2. Troubleshooting & Investigations

• Support investigations, root cause analysis, and issue resolution related to packaging and inspection processes.

3. Process Improvements

• Identify and implement initiatives to reduce operational costs while ensuring product quality in inspection and packaging operations.

4. Process Characterization & Validation

• Establish testing strategies.
• Design and develop characterization protocols.
• Prepare technical reports.
• Support SAT execution, document generation, challenge validation strategies, and related activities.
• Conduct risk assessments; working knowledge of QRAES is preferred.

5. Project Coordination

• Oversee material requests, training coordination, production windows, and generation of work orders.

6. General Skills

• Strong technical documentation skills (oral and written).
• Proficiency with MS Word, Excel, PowerPoint, PDF, Visio, and MS Project.
• Basic project management skills (timeline follow-up, schedule reviews, predecessor tracking).
• Flexibility to support multiple shifts (1st, 2nd, or 3rd) and extended hours up to 12 hours based on project needs.
• Strong interpersonal skills and ability to work with OEMs and cross-functional teams.
• Self-driven, organized, and schedule-oriented.

Functions

• Conceive, design, execute, and interpret experimental strategies.
• Provide input to ensure robust and reliable process data.
• Ensure studies comply with protocols, guidelines, and applicable regulations.
• Analyze and interpret data to determine project impact.
• Stay current in scientific expertise and relevant technology.
• Introduce advanced scientific methods and novel protocols as needed.
• Represent the department on project teams (as assigned).
• Collaborate within and outside the department to support scientific initiatives.
• Author scientific reports, summaries, regulatory documents, and patent submissions.
• Participate in external scientific activities and internal committees.
• Support department efforts such as safety, recruiting, and mentoring.
• Establish and maintain timelines for assigned project work.

Education

• Doctorate, OR
• Master’s degree + 2 years of scientific experience, OR
• Bachelor’s degree + 4 years of scientific experience.

Competencies / Skills

• Advanced scientific analysis, troubleshooting, and laboratory skills.
• Ability to motivate and supervise others when required.
• Strong organizational and multitasking capabilities.
• Excellent verbal and written communication skills, including technical writing.
• Skills in negotiation, conflict resolution, and analytical problem-solving.
• Project management experience.
• Adaptability and ability to manage change.
• Proficiency with Windows-based applications (Word, Excel, PowerPoint).
• Application of scientific theory and creativity in experiment design and interpretation.
• Strong knowledge of cGMP requirements.
• Fully bilingual (English/Spanish).

If you meet these qualifications and are interested in this opportunity, we encourage you to apply through the job description link and submit your updated resume.