Principal Container Engineer, R&D Disposables
Posted on: May 28, 2023
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.
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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
Keywords: Haemonetics, Boston , Principal Container Engineer, R&D Disposables, Engineering , Boston, Massachusetts
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