Position Summary 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. Key Responsibilities 1. Project Planning & Design Leadership 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. 2. Engineering Standards & Compliance 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. 3. Technical Execution & Support 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. 4. Vendor & Equipment Interface 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. 5. Documentation & Project Controls 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. 6. Commissioning & Qualification Support Provide technical guidance during commissioning and packaging line startup. Support change control evaluations and assess the technical and compliance impact of proposed modifications. Qualifications 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. Core Competencies 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 Work Environment On‑site role in a controlled manufacturing environment. May require flexible working hours depending on project needs. #J-18808-Ljbffr