Engineering Specialist - Packaging Operations

The Packaging Engineering role provides technical expertise for the optimization, design, and troubleshooting of packaging systems within a regulated pharmaceutical or biotech environment. Under general supervision, the engineer will apply foundational engineering principles to address operational issues, implement system modifications, and support capital projects related to secondary packaging operations. The position plays a critical role in ensuring compliance with regulatory standards and the continuous improvement of packaging processes and materials.

Key Responsibilities :

• Provide technical solutions to a range of moderate complexity issues in secondary packaging operations.
• Serve as a subject matter expert in the troubleshooting and optimization of packaging equipment and processes.
• Actively participate in daily packaging operations to resolve issues and ensure adherence to schedules.
• Routinely audit packaging system performance and compliance with GMP / GDP standards.
• Collaborate cross-functionally with departments such as Manufacturing, Facilities, Process Development, Quality Assurance, Validation, and Maintenance.
• Recommend and implement system modifications and continuous improvement initiatives.
• Assist in executing packaging-related engineering and construction projects under the supervision of project managers.
• Collaborate with vendors, consultants, and engineering firms on equipment selection, packaging component design, and process implementation.
• Obtain and assess vendor quotes for equipment modifications or installations.
• Support the creation of cost estimates and project schedules for packaging initiatives.
• Support development, execution, and documentation of test protocols for packaging materials and processes.
• Ensure compliance with ASTM D4169, ISO, TAPPI, USP, and EP testing standards.
• Evaluate the performance of secondary packaging components (e.g., bottles, labels, trays, lidding, leaflets, sterile barriers, corrugate).
• Generate technical reports and summaries based on testing outcomes and evaluations.
• Ensure all work adheres to internal SOPs and external regulatory requirements (GMPs, GDPs, GLPs).
• Support validation protocol development, execution, and report generation.
• Maintain thorough and accurate documentation to support regulatory audits and quality investigations.

Requirements

Required Qualifications :

Preferred Qualifications :

Benefits