Senior Research

ABOUT SANISURE 

SaniSure is a multinational manufacturer of single-use bioprocessing solutions (SUT) used in the production of biological drugs, including monoclonal antibodies, cell therapies, gene therapies, and vaccines. With operations in the U.S. and in Europe, SaniSure operates a leading platform of vertically integrated critical fluid management technologies and integrated solutions. Its single-use products and system solutions are sold to global pharma and biotech companies and are used from R&D through full-scale commercial cGMP manufacturing of among the most innovative large molecule therapeutics and vaccines. 

We continue to be on a robust growth trajectory, via both organic and inorganic growth, as the company capitalizes on increasing global demand and continues its transition from a component manufacturer to an integrated systems and solutions provider.

Our primary offering includes high-value assembly solutions and a portfolio of market-leading products, including PharmaTainer bottles and carboys and related assemblies, Mixed4Sure mixing solutions, Flex4Sure bags and bag assemblies, Fill4Sure needles and needle assemblies, fittings, clamps and a wide range of silicone, braided and thermoplastic tubing solutions. The company has a growing portfolio of innovative solutions serving fast-growth applications, such as cell and gene therapies.

SaniSure is a high-growth, nimble and innovative company with a strong customer and market focus. Join us and grow your career at SaniSure

SUMMARY:

The Senior Research and Development Engineer leads research, design, and development of components and complex assemblies for critical bioprocessing applications.  This individual will support innovation and product development through all stages, from ideation and concept, to prototyping, and through commercialization.  Research and Development will result in deliverables and turnover packages that support swift industrialization.

ESSENTIAL FUNCTIONS:

• Translate business needs and market trends into product requirements and innovative engineering solutions.
• Stay current with emerging technologies, materials, and industry trends to maintain competitive advantage.
• Drive innovation by exploring new technologies, tools, and methodologies.
• Support intellectual property strategies by identifying patentable technologies, working with legal team.
• Partner with cross-functional teams to ensure successful product development and launch, adhering to established stage-gated process and governance model.
• Effectively project manage timelines, budgets, and resources to deliver high-quality results.
• Oversee the planning, design, development, prototyping, testing, and validation of new products and technologies.
• Conduct risk assessments using FMEA framework, and drive risk mitigations as required.  Lead design and drawing reviews as needed.
• Ensure compliance with applicable regulatory, safety, and quality standards throughout the development process.
• Lead problem-solving, corrective, and preventative actions around product concerns originating both external and internal to the organization.
• Analyze data from validation tests to determine whether systems and processes meet required criteria and specifications.
• Maintain technical records within design history files.
• Drive continuous improvement in product performance, design for manufacturability (DFM), and design for cost-effectiveness (DTC).
• Develop and implement engineering best practices, design standards, and documentation protocols.  Author SOP's, Work Instructions and Templates.
• Support Product Delivery Teams (PDT), including creating and or reviewing quality documents, participating in Corrective And Preventive Action (CAPA) implementation, and generating or supporting ECR (Engineering Change Request) & ECO (Engineering Change Order) activities.
• Work with Scientists and Engineers internally and externally to assess and develop appropriate design and manufacturing specifications.
• Perform other duties as assigned

QUALIFICATIONS:

• 7 years of engineering experience within a biotechnology or pharmaceutical manufacturing facility.
• 4 years of Single-Use Technology (SUT) design experience.  Preferred experience includes design with tubing, bags, and filling needles.
• Demonstrated expertise in the design of molded plastic parts and assemblies for fluid handling of leak-proof applications.
• Thorough understanding of industry standards and regulatory guidelines.  Knowledge of ISO 13485, ASME BPE, or related design standards.
• Proven track record in product development, from concept through commercialization.
• Ability to manage multiple projects in a fast-paced, collaborative environment.  Results-driven mindset with keen sense of urgency and ability to deliver ahead of deadlines.
• Demonstrated attention to detail.   Excellent follow-up skills.
• Must be self-motivated, amendable to a variety of work projects and work efficiently independently and as part of a team.
• Strong knowledge of design controls, prototyping technologies such as 3D printing, testing, and validation methodologies.
• Able to read and comprehend and interpret documents such as drawings, BOM's, blueprints, and operating procedures.  Able to train and guide less experienced personnel on proper interpretation and best practices.
• Maintain organized and controlled records of all drawings and BOM's.   Drive and facilitate assigned portions of product change management and control.
• Solid understanding of mathematical fundamentals of plane and solid geometry, fractions, percentages, ratios, and proportions applied to practical situations.
• Ability to interpret complex data sets, identify patterns, and draw meaningful conclusions.  Author scientific reports with conclusions and recommendations.  Use data to drive decisions tied to the business context.
• Expert knowledge and demonstrated hands-on experience with CAD software, both 3D and 2D.
• Proficient with Microsoft Office Suite or related software.
• Excellent verbal and written communication skills.
• Strong interpersonal skills: ability to interact with staff at all levels within the organization.
• Proactive approach to identifying opportunities for improvement and driving positive change.
• Develop and maintain positive rapport and working relationships with other personnel across the organization in support of initiatives to execute product improvements and enhancements.
• Experience working in a GMP (Good Manufacturing Practice) or laboratory environment.

Equal Opportunity Employer

We are committed to providing equal employment opportunities to all employees and applicants without regard to race, ethnicity, religion, color, sex (including childbirth, breast feeding and related medical conditions), gender, gender identity or expression, sexual orientation, national origin, ancestry, citizenship status, uniform service member and veteran status, marital status, pregnancy, age, protected medical condition, genetic information, disability or any other protected status in accordance with all applicable federal, state and local laws.