Sr. Validation Engineer

Flexible & Integrated Technical Services, LLC•Juncos, PR

About The Position

For C&Q services in the Engineering area. 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! Are you the next piece?

Requirements

Bachelor's Degree in Engineering
Four (4) years of Assembly and Packaging Process experience.
Bilingual (English & Spanish).
Project Management skills.
Experience in C&Q Process
Experience in Validation and Packaging Equipment

Responsibilities

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.