This position is responsible for providing leadership, strategy and follow-through in the design, development, testing, coordination, and implementation of packaging technology and systems for Bard's products. The position is responsible for interfacing and/or interacting with management and appropriate project teams to evaluate packaging design and implement efficient changes, meeting internal and external customer needs through timely management and response from the R&D Packaging Lab, communications, as well as facts and data that have a direct impact on budget, headcount, resource and capacity utilization and project timelines. The manager will work directly with R&D Packaging Engineering and packaging suppliers while staying abreast of current trends, development activities, and potential new packaging platforms. The position and function are responsible for package design and material qualification, closure integrity and adherence to ISO, FDA and other domestic and international regulations pertaining to packaging systems. Development and implementation of Standard Operating Procedures for design development, material selection, and design control are further requirements. Lead, develop and train staff for Bard/BD and ISO procedure compliance are essential. Packaging support is provided to Bard/BD's manufacturing facilities. This position and in alignment with the global regulatory function/department is an active team member on international industry and regulatory committees as it relates to packaging.
Job Description
We are the makers of possible
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.
We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us.
Responsibilities:
Manages the evaluation, development, and implementation of global packaging systems. This requires a high and demonstrable level of functional input and application with respect to quality, efficiency, and productivity.
Manages and establishes scientific and technical packaging test standards, support and requirements which includes any changes related to package design. Contributes to and approves where required technical reports and qualification reports. Provides packaging support to all Bard/BD R&D and manufacturing sites through testing requests.
Assumes a leadership the role of global packaging team and for design test requirements. Assures project key milestones dates are met and supported by setting required scientific and technical standard. Ensures meeting project objectives while remaining within agreed to project budgets.
Administrates Packaging Design and Development Lab by way of capability improvement, staff development, and allocation of resources, planning and budgeting. Performs administrative and manager duties including interviewing applicants for employment, reviewing progress of assignments, performance appraisals, recommending salary increases and developing high level of expertise in staff members. Also, ensures that all personnel enforce to SOP's, Bard Corporate Standards, departmental policies and other applicable safety procedures.
Provides a leadership and mentorship role on current and proposed packaging regulatory matters specific to documentation and audits. Team member / mediator on international industry and regulatory committees related to future ASTM, FDA, and ISO packaging mentorship documents.
QUALIFICATIONS
To perform this job successful, an individual must be able to perform each crucial duty satisfactorily. The requirements listed in this section and below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Experience with packaging stability studies and packaging performance testing preferred.
Understanding of sophisticated applied statistics as relates to packaging processes.
Excellent communication skills (verbal, written, and presentation).
ISTA CPLP professional certification, IOPP CPP certification, and/or ASTM D10 or F02 committee preferred.
Understanding of GMP, ISO 11607 and 13485, FDA, ISTA, ASTM and other regulatory issues relating to medical device packaging.
EDUCATION and/or EXPERIENCE
B.S. Degree in Engineering field required. Advanced degree preferred.
3 - 5 years direct experience working in regulated or healthcare field.
Package design and materials selection, through criteria evaluation, validation, and implementation preferred.
Packaging Testing Lab and supervisory experience preferred.
Understanding of GMP, ISO 11607 and 13485, FDA, ISTA, ASTM and other regulatory issues relating to medical device packaging.
COMPUTER SKILLS
Proficient with SharePoint and MS Office including PowerPoint, Outlook, Project, Excel and Word.
Able to comprehend and use computer-controlled laboratory equipment.
TOP/CAPE, CAD and Solidworks preferred
For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Why Join Us?
A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.
To learn more about BD visit https://bd.com/careers
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
