Sr. Principal Engineer

Company Description

• Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
• We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

Job Description

Job Description:

• This position is a contract Packaging Engineering position within Client's Pharmaceutical segment R&D group. With some supervision, performs sustaining engineering activities on current product packaging and packaging processes with priorities based on quality and compliance, continuity of supply, and cost savings initiatives.
• When applicable, will support new product development teams by acting as an extended team member to provide the design, development and verification testing of new product packaging and assist the manufacturing plants in qualification of new packaging processes.
• This position applies a solid understanding of theories/practices utilized in the field of packaging. The position will include exposure to several types of packaging materials and processes including flexible and rigid films, HDPE and foil pouches, corrugated design and protective packaging, thermoforming, flow-wrap, form/fill/seal, printing technologies and other related packaging processes. The position may require travel to the manufacturing plants and packaging suppliers.

Responsibilities:

• Lead and/or contribute to the planning and execution of packaging projects for a variety of project types including Quality/CAPA, Regulatory Compliance, Supplier Notices of Change, Cost Savings, and New Product Introductions at various domestic and international manufacturing facilities.
• Manage projects with moderate complexity and scope and be required to effectively manage multiple projects with minimal assistance and supervision. May work on a large-scale program or several smaller projects.
• Develop protocols for testing and engage in Change Control activities interfacing with multiple functional groups, including manufacturing plants and suppliers in a team environment to execute packaging changes.
• Approve new packaging materials and systems, studying and recommending techniques to improve and/or cost reduce existing products/processes, investigating new sources for packaging materials.
• Create packaging material specifications, associated drawings, and packaging procedural specifications to provide the required technical information necessary to support the product/packaging configuration.
• Plans, schedules, and collaborates with cross-functional team supporting packaging projects to achieved project objectives and milestones.
• Expected to utilize their experience to generate cost savings ideas by recommending new materials or design modifications and resolve packaging issues by using critical thinking skills and DMAIC techniques to solve complex problems.
• Perform financial planning and assists in the analysis to justify project approval.

Requirements:

• B.S. in Packaging or relevant Engineering degree (e.g. Mechanical, Chemical, Biomedical) with a minimum of 5 years of experience.
• Must have experience or advanced training and demonstrate proficiency in packaging materials and processes, problem analysis and resolution, statistical methods, and design of experiments.
• Proficient in applicable change control and development methodology and processes required to execute packaging projects.
• Successful track record of managing packaging projects possessing a sense of urgency and commitment to meet project milestones to ensure manufacturing plants and R&D teams achieve targeted goals.
• Cross-functional team experience, including technical and non-technical work.
• The ability to deal with ambiguity and effective use of creative problem solving skills.
• Embrace Lean Principals and utilize concepts such as standard work to drive continuous improvement.
• Ability to organize and present technical and project management overviews with minimal assistance.
• Experience in the Medical Field.

Additional Information

All your information will be kept confidential according to EEO guidelines.