Job Description

For C&Q services in the Engineering area.

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelor's Degree in Engineering with four (4) years of Assembly and Packaging Process experience.
• Bilingual (English & Spanish).
• Project Management skills.
• Shift: Administrative and according to business needs.00
• Experience in:
  • C&Q Strategy & Planning
  • Commissioning Activities
  • Qualification Execution (IQ/OQ/PQ)
  • Documentation & Compliance
  • Cross-functional Coordination

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

• Develop and implement the overall Commissioning & Qualification strategy aligned with project and regulatory requirements.
• Develop C&Q plans, schedules, and resource forecasting.
• Oversee and/or execute commissioning activities including FAT, SAT, and field commissioning.
• Ensure systems are installed and operate per design specifications.
• Coordinate with vendors and contractors during startup activities.
• Review and approve commissioning documentation and test results
• Author, review, and approve qualification protocols (IQ, OQ, PQ).
• Ensure traceability from User Requirements Specifications (URS) through testing.
• Execute or oversee protocol execution and ensure proper documentation of results
• Ensure all C&Q documentation complies with GMP, FDA, EMA, and internal Amgen standards.
• Maintain document lifecycle within electronic systems.
• Support data integrity and ALCOA+ principles throughout qualification activities.
• Prepare and support validation summary reports.
• Lead and document risk assessments related to system qualification.
• Evaluate and manage change controls impacting validated systems.
• Assess impact of deviations and implement corrective and preventive actions (CAPA)
• Develop the characterization protocols.
• Execute the characterization activities.
• Develop and review the characterization reports.
• Collaborate with Engineering, Validation, Quality Assurance (QA), Manufacturing, and Supply Chain teams.
• Interface with system owners and technical authorities.
• Provide technical guidance and mentorship to junior engineers and project team members.
• Support project meetings, status reporting, and stakeholder communication.

WHO WE ARE:

We are a Service Provider company different 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 industry clients with top-notch quality talent. We're FITS!

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