ProQuality Network

Process Development Scientist

Caguas, Caguas, PR

5 days ago
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Summary

📌 Job Opportunity: Process Development Scientist

Location: East Region of Puerto Rico (Open only to Puerto Rico residents)

Work Schedule: 100% Onsite | Administrative Shift

Contract Duration: Approximately six (6) months

Open Positions: 1

🔬 About The Role

Our client is seeking a highly motivated and skilled Process Development Scientist to support packaging and vision system operations within a regulated biotechnology environment. This is a 100% onsite position and requires active collaboration across multidisciplinary teams to ensure technical excellence and compliance with applicable standards.

As part of the process development group, the selected candidate will:

  • Conceive, design, and implement scientific experiments under general guidance.
  • Evaluate and interpret experimental data to support project goals.
  • Ensure all studies comply with protocols, cGMPs, and applicable industry regulations.
  • Provide technical input to develop robust and reliable processes.
  • Monitor relevant scientific literature and technology trends to support innovation.
  • Collaborate internally and externally to drive scientific solutions.
  • Lead or contribute to regulatory and scientific documentation efforts.

🎯 Key Responsibilities

  • Develop and execute process characterization, particularly in packaging and vision systems.
  • Design and implement experimental protocols, risk assessments, and validation strategies.
  • Write technical reports to support system acceptance testing (SAT), IQ/OQ/PQ, and challenge validations.
  • Conduct QRAES and risk assessments related to system or process performance.
  • Participate in project timelines, ensuring on-time and quality delivery.

💡 Preferred Qualifications

Education & Experience:

  • Doctorate degree, or
  • Master’s degree with 5 years of scientific experience, or
  • Bachelor’s degree with 6 years of scientific experience.

Technical Skills (experience Or Understanding Of Several Is Preferred)

  • Vision systems & tools: Cognex, Systech, Optel, Keyence, Seidenader, Brevetti, EISAI/Bosch/Syntengon
  • Camera system technologies: Analog/digital cameras, illumination, lenses, frame grabbers
  • Artificial Intelligence & Deep Learning
  • PLC programming: Rockwell Automation, Allen Bradley, Siemens Simatic/TIA, B&R
  • Programming languages: Visual Basic, .Net, Visual C#, Python, JScript, VBScript
  • Automation & Compliance: SDLC, 21 CFR Part 11, GAMP, IQ/OQ/PQ, URS, HDS, SDS, P&IDs
  • Experience in Tech Transfer, Process Design, Commissioning & Qualification
  • General Competencies:
  • Fully bilingual (Spanish and English)
  • Strong communication (oral and written)
  • Technical writing and documentation
  • Project and time management
  • Conflict resolution and problem-solving
  • Leadership, collaboration, and negotiation
  • High compliance mindset with cGMP knowledge
  • Computer literacy: Word, Excel, PowerPoint, Minitab

✅ Core Competencies

  • Scientific theory application and experimental design
  • Advanced troubleshooting and laboratory skills
  • Analytical and creative problem-solving
  • Supervisory and mentoring capabilities
  • Strong understanding of risk management and quality assurance
  • Flexible, organized, and detail-oriented

🔗 Interested in making an impact in the biotechnology industry?

Apply today through the job description link provided — we look forward to reviewing your qualifications!

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