Job Description

Inteldot has over 14 years in the life sciences industry with allocations across Puerto Rico, the United States, Europe, and Japan. This is a great opportunity for one of our leading clients in the USA.

Shift: Administrative (8:00AM - 5:00PM) unless the project demands.

Job Description

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, ensuring that all packaging-related deliverables meet quality, safety, and compliance expectations throughout the project lifecycle. Coordination experience, and the ability to interface effectively with engineering, quality, and operations teams.

Employment Type: Contract / Full-Time
Start Date: Immediate / As soon as available

Functions

1. Project Planning & Design Leadership

Prepare front-end planning and design documents for packaging systems and equipment.
Lead the design process for packaging lines, including material handling, labeling, cartoning, and palletizing systems.
Provide value engineering solutions and creative problem-solving approaches to optimize design and cost.
Participate in the development of project sourcing strategies, identifying opportunities for vendor optimization and standardization. 2. Engineering Standards & Compliance Evaluate client packaging standards and libraries against project scope; issue or update relevant specifications and design standards as needed.
Review project plans to ensure adherence to client and industry engineering standards (e.g., ISO, FDA, cGMP, ASTM).
Identify possible deviations to client specifications, prepare variance submittals, and drive approval processes.
Ensure that Factory Mutual (FM) loss prevention, EHSS (Environment, Health, Safety & Sustainability), and ergonomics considerations are addressed in packaging system design.

3. Technical Execution & Support
Provide technical support during project execution, acting as the lead for resolution of packaging-related discrepancies or design challenges.
Serve as liaison to engineering authorities, subject matter experts, consultants, and the engineer of record on packaging matters.
Lead and coordinate the RFI (Request for Information) and submittal review process for packaging equipment and components.
Manage engineering change controls and ensure documentation reflects approved design revisions. 4. Vendor & Equipment Interface
Act as primary point of contact between packaging equipment vendors and the client's engineering team.
Support the development of FAT (Factory Acceptance Test) protocols and lead FAT activities to verify compliance with design intent.
Ensure project plans and layouts are fit for the introduction and installation of new packaging equipment.
Oversee SAT (Site Acceptance Test) and DQ (Design Qualification) activities, preparing and approving DQ reports for Level 1 systems.

5. Documentation & Project Controls
Establish and manage methods for information and document control, preferably through e-Builder or similar systems.
Track design progress against project plans and ensure alignment with overall project schedules.
Maintain detailed documentation to support validation, qualification, and compliance requirements.

6. Commissioning & Qualification Support
Provide technical consultation to the commissioning and qualification workstreams during packaging line startup.
Support clients change control evaluation processes by assessing the technical and compliance impact of proposed modifications.

Qualifications: 

• Education: Bachelor's degree in Mechanical Engineering, Packaging Engineering, Industrial Engineering, or related discipline.
• Experience: 5+ years of experience in packaging design, validation, or equipment integration, preferably within pharmaceutical, biotechnology, or life sciences industries.
• Technical Skills:
  • Strong knowledge of packaging machinery (cartoners, labelers, case packers, palletizers)
  • Familiarity with cGMP, validation protocols (DQ, IQ, OQ, PQ), and FDA regulations.
  • Experience with AutoCAD, SolidWorks, or equivalent CAD software, Office 365
  • Proficiency in e-Builder, MS Project, or other project management tools preferred.

Job Tags

Full time, Contract work, Work at office, Immediate start, Shift work,

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