Renaissance Pharmaceuticals

Overview

The Sr. Packing Engineer is responsible for sustaining engineering activities on current product packaging and packaging equipment/processes with priorities based on quality and compliance, continuity of supply, and cost savings initiatives. In addition, you will provide package design, development, verification testing activities for new products and in the successful design transfer and qualification of new packaging equipment / processes.

Responsibilities

• Partner with commercial and development clients to establish packaging designs and associated
packaging equipment / process to ensure design for manufacturability including primary,
secondary, and tertiary packaging, labelling, serialization, etc.
• Create packaging material specifications, associated drawings, and packaging procedural
specifications to provide the required technical information vital to support the
product/packaging configuration.
Support the site in the development and execution of a packaging design and equipment strategy
that drives towards standardization and efficiencies while providing clients with standard
packaging solutions.
• Investigate and resolve equipment operating, reliability, and yield issues and implement
corrections or modifications to ensure systems operate within qualified parameters.
• Implements connective/preventive actions for existing equipment and manufacturing processes.
• Collaborates with multi-functional teams (i.e. Development, QA/QC, Supply Chain, MS&T,
Validations, Operations, Regulatory, Suppliers, Clients, etc.) in pre-commercial and commercial
activities.
• Prepare documents for support of projects including project scopes, presentation of conceptual
designs, capital requests, specifications, process flow diagrams, schedules, requests for
quotations, project expenditures, project procedure, correspondence, start-up procedures and cost
estimates.
• Support Validation and MS&T departments through the preparation of design documents and assisting
in protocol generation and execution.
• Prepare change control documentation to ensure successful technical transfer to manufacturing.
• Manage small to large size packaging projects related to process equipment and manufacturing.
• Prepare labor-requirement estimates for new and existing packaging arrangements.
• Ensure projects are on time and on budget.
• Ensure safety, environmental, and ergonomic risks are identified and mitigated. Safety of our
employees is our top priority.
• Apply engineering tools to solve straightforward packaging problems (e.g. FMEA, Design of
Experiments, A3).
• Perform other duties and responsibilities as assigned.

Qualifications

B.S. degree in Packaging or Mechanical Engineering, with 5-8 years of relevant packaging experience.

Must possess:
• Expertise in medical device packaging test methods/standards, processes and related equipment
• Medical device packaging system verification and validation experience
• Advanced knowledge of engineering documentation required for cGMP process equipment
• Successful track record of implementing packaging projects
• Strong interpersonal and communication skills to collaborate externally with supplies and
clients, as well as internally.
• Project Management experience
• Deal with ambiguity, Business Acumen, Conflict management, Problem solving, Drive for results;

Preferred:
• Experience with automated inspection and serialization systems.