Principal Container Engineer, R&D Disposables

Company: Haemonetics
Location: Boston
Posted on: May 28, 2023

Job Description:

We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further - Haemonetics is your employer of choice.

Job Details

The Principal Container Engineer, Disposables R&D shall provide relevant subject matter expertise in container polymer material evaluation and characterization in order to support and progress Solutions Business Unit (BU) initiatives, for the drug/container portfolio.

• Attends BU core teams and represents R&D together with Solutions SME. Supports and owns R&D activities in support of BU initiatives, including contract manufacturing/partnerships, sustaining, product changes (material/film, etc.), etc., for container projects.
• May lead projects for cross function teams as subject matter expertise (SME) from development and CMC section preparation for regulatory filing to technical transfer for commercial production.
• Review work, results, data, reports, and any other documents generated by peer staff to ensure compliance with current GMP/GLP, specifications, standard operating procedures, and regulatory requirements.
• Builds and tests new designs, formulations, materials, or systems for compliance with quality and/or performance standards. Processes, and analyzes results and data.
• Author and/or review/approve pertinent protocols, report, pharmaceutical development reports and CMC sections for regulatory filings.
• Conduct and/or oversee polymer material chemical/physical characterization studies for container materials such as resin, stoppers, inks, solvents, adhesives, container films, etc.
• Understand the latest state of the art analytical techniques, analytical software and databases that identify and quantify chemical impurities e.g. extractables, leachables, degradation/reaction products, additives, etc., and the impact on drug/solution container materials.
• Understand the drug's/chemical's impact on container materials and provide hypothesis on possible degradation and/or interaction pathways of active ingredient(s) in drug product formulations.
• Continue to develop expertise in areas related to container/film development and drug degradation pathways.
• Support design transfer and sustaining activities as the focal point from a container perspective, supporting Manufacturing's container production equipment. May spec new technology or aide in supporting existing tooling/equipment in Manufacturing.
• Responsible for capturing programmatic and/or technical risks and coordinating retirement strategies. Resolves problems and makes decisions requiring technical depth.
• The job description listed is not exhaustive and shall also include any responsibilities as signed by the supervisor from time to time.
• Collaborates and interfaces extensively in and outside R&D, both within and outside the company. Works effectively with multiple diverse technical and business functions, and uses tact and discretion to resolve conflicts. Displays solid written and verbal communication and presentation skills, and communicates effectively with customers, multiple teams and diverse stakeholders at all levels.
• Ensures financial, technical design, quality, and project management accountability for resources and results; works with other teams, Program Managers and leaders to achieve strategic Systems goals and integration needs; ensures highest level of global compliance, quality, and ethics in conjunction with the Code of Business Conduct and other Company policies.
• Serves and is recognized as the premier Container subject matter expert within Disposables R&D and validates all technical components and results. MINIMUM REQUIRED EDUCATION AND EXPERIENCE
  • Pharmaceutical Industry experience.
  • Bachelor's Degree in related Engineering, Material, Chemistry or Technical discipline.
  • 10+ years of experience in container development in the medical device industry, including sustaining and new product introduction.
  • The Container Engineer is expected to have broad knowledge of principles, practices and procedures in disposables medical device container development. This includes the regulatory environment within the US and EU and functional/driving aspects of QMS and cGMP.
  • Solid leadership experience with Executive level Stakeholder communication skills. Ability to manage and define business needs into tactical, cost effective, and feasible program /project plans and development strategies.
  • Work under minimal supervision. Relies on experience and judgement to plan and accomplish assigned work. Judgement is required in resolving complex problems based on experience.
  • Occasional business travel required. KNOWLEDGE, SKILLS AND ABILITIES
    • Requires full working knowledge of professional field and pharmaceutical industry in cGMP environment. Influences the development of and drives the application of principles, theories, concepts. Determines best course of action.
    • Must have demonstrated experience and subject matter expertise in one of more of the role relevant areas: analytical chemistry, material science, pharmaceutics, drug delivery, combination products, pre-formulation, reaction mechanisms / organic chemistry.
    • Working knowledge of chemical theories, concepts, test methods and instrumental methods, analytical and research skills.
    • Broad understanding and knowledge of USP, EP, cGMP/GLP, FDA CFR & ICH regulations and guidelines.
    • Experience of polymer characterization with USP661.1, 661.2, 381, 87, 88, ISO-10993 evaluation for materials used for pharmaceutical and medical device is plus.
    • Thorough understanding of the pharmaceutical development process and regulatory workflows (IND, ANDA, NDA etc.) with focus on injectable drugs or combination products.
    • Strong communication (written and verbal), attention to detail and organizational skills as demonstrated in writing project proposals, protocols and reports.
    • Scientific contribution skills as demonstrated by posters, presentations, patents or presentations.
      
      EEO Policy Statement
      
      Conditions of Employment: Haemonetics's requires COVID-19 vaccination for all U.S. employees who work in the presence of other colleagues or customers, unless the employee is approved for a medical or religious exemption, pursuant to applicable law. While we recognize employees have their own individual beliefs and perspectives regarding vaccination, we believe it is an important step as part of our obligation to protect our colleagues, customers and communities as we continue to make health and safety our top priority.

Keywords: Haemonetics, Boston , Principal Container Engineer, R&D Disposables, Engineering , Boston, Massachusetts