ETL - Packaging Engineer

Technical & Engineering Consulting•Juncos, PR

2d•Onsite

About The Position

The Packaging Engineer will be responsible for leading and executing packaging design, validation, and implementation activities in alignment with client engineering standards, project scope, and regulatory requirements. This position combines hands-on technical expertise in packaging systems with leadership responsibilities consistent with an Engineering Technical Lead role, ensuring that all packaging-related deliverables meet quality, safety, and compliance expectations throughout the project lifecycle.

Requirements

Bachelor’s degree in Mechanical, Industrial, or Packaging Engineering (or related discipline).
5+ years of experience in packaging engineering within regulated industries (pharmaceutical, medical device, or biotech preferred).
Strong knowledge of cGMP, FDA, and ISO standards related to packaging systems.
Experience with design tools, document management systems, and validation documentation.
Proven ability to lead multidisciplinary engineering projects and vendor coordination.
Analytical thinking and creative problem-solving
Strong written and verbal communication skills
Organization, leadership, and autonomy
Attention to detail and quality-focused mindset
Collaboration across engineering, operations, and quality teams

Responsibilities

Prepare front-end planning and design documentation for packaging systems and equipment.
Lead the design and integration of packaging lines, including material handling, labeling, cartoning, and palletizing systems.
Provide value engineering and creative problem-solving solutions to optimize performance and cost.
Participate in sourcing strategies, identifying opportunities for vendor optimization and standardization.
Evaluate client packaging standards and ensure alignment with project scope and objectives.
Review designs for compliance with ISO, FDA, cGMP, ASTM, and other applicable industry standards.
Identify and manage deviations, prepare variance submittals, and coordinate approvals.
Integrate EHSS (Environment, Health, Safety & Sustainability), Factory Mutual (FM), and ergonomic considerations into all packaging designs.
Provide technical leadership during project execution to resolve packaging-related design challenges.
Serve as the liaison between internal teams, subject matter experts, and external engineering authorities.
Lead and coordinate RFI (Request for Information) and submittal review processes for packaging equipment and components.
Manage engineering change control documentation to ensure traceability and compliance.
Act as the primary technical contact between packaging equipment vendors and client engineering teams.
Develop and lead FAT (Factory Acceptance Test) protocols to verify design compliance.
Oversee SAT (Site Acceptance Test) and DQ (Design Qualification) activities, preparing and approving DQ reports for Level 1 systems.
Ensure that project layouts and installation plans are suitable for new equipment integration.
Establish document control processes using e-Builder or similar systems to manage design deliverables.
Track progress against project milestones and schedules.
Maintain detailed documentation supporting validation, qualification, and compliance requirements.
Provide technical guidance during commissioning and packaging line startup.
Support change control evaluations and assess the technical and compliance impact of proposed modifications.