Sr. Engineer (Packaging & Validation) 35333

Inteldot•Juncos, PR

About The Position

Independently leads process optimization initiatives and troubleshooting activities within manufacturing, operations, pilot plant, and capital project environments. Applies advanced engineering principles to the design, implementation, and qualification of manufacturing systems, process improvements, and capital projects. Develops, analyzes, and presents technical solutions and project results for complex engineering challenges.

Requirements

Bachelor's Degree in Engineering with a minimum of four (4) years of relevant engineering experience; or Master's Degree in Engineering with a minimum of two (2) years of relevant engineering experience.
Experience in Packaging Process Engineering.
Experience in Commissioning & Qualification (C&Q).
Experience with C&Q Strategy & Planning.
Experience with Commissioning Activities (FAT, SAT, field commissioning).
Experience with Qualification Execution (IQ/OQ/PQ).
Experience with Documentation & Compliance (GMP, FDA, EMA, internal quality standards).
Experience with Risk Management & Change Control.
Experience with Cross-Functional Collaboration.
Experience with Process Characterization.

Nice To Haves

Experience with risk assessments (e.g., ISPE Baseline Guide, ASTM E2500).
Experience maintaining qualification documentation within electronic document management systems.
Experience supporting Data Integrity and ALCOA+ principles.

Responsibilities

Lead process optimization initiatives and troubleshooting activities within manufacturing, operations, pilot plant, and capital project environments.
Apply advanced engineering principles to the design, implementation, and qualification of manufacturing systems, process improvements, and capital projects.
Develop, analyze, and present technical solutions and project results for complex engineering challenges.
Develop and implement Commissioning & Qualification (C&Q) strategies aligned with project objectives and regulatory requirements.
Define system boundaries and identify direct and indirect impact systems.
Lead risk assessments to determine qualification scope.
Develop C&Q plans, schedules, and resource forecasts.
Lead or execute commissioning activities, including FAT, SAT, and field commissioning.
Verify systems are installed and operate according to design specifications.
Coordinate startup activities with equipment vendors and contractors.
Review and approve commissioning documentation and test results.
Author, review, and approve IQ, OQ, and PQ protocols.
Ensure traceability from User Requirements Specifications (URS) through qualification testing.
Execute or oversee protocol execution and ensure complete, accurate documentation.
Ensure all C&Q documentation complies with GMP, FDA, EMA, and internal quality standards.
Maintain qualification documentation within electronic document management systems.
Support Data Integrity and ALCOA+ principles throughout qualification activities.
Prepare validation summary reports.
Lead risk assessments supporting system qualification.
Evaluate and manage change controls affecting validated systems.
Assess deviations and implement appropriate CAPA actions.
Collaborate with Engineering, Validation, Quality Assurance, Manufacturing, and Supply Chain teams.
Interface with system owners and technical stakeholders.
Provide technical guidance and mentorship to junior engineers and project team members.
Support project meetings, status reporting, and stakeholder communications.
Develop characterization protocols.
Execute characterization activities.
Analyze results and prepare characterization reports.