Senior C&Q Engineer
Flexible & Integrated Technical Services, LLC
Juncos
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JOB DETAILS
SKILLS
Biotech and Pharmaceutical, C Programming Language, Calendar Management, Change Control, Change Management, Commissioning, Construction Engineering, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Data Quality, Documentation, English Language, Forecasting, Manufacturing, Medical Equipment, Mentoring, Multilingual, Process Validation, Project/Program Management, Quality Assurance, Regulatory Requirements, Requirements Management, Risk Analysis, Spanish Language, Startup, Strategic Planning, Supply Chain, System Validation, Systems Administration/Management, Technical Leadership, Traceability, Writing Skills
LOCATION
Juncos
POSTED
Today
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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