Sr Principal Engineer - Combination Products
Company: Bristol Myers Squibb
Location: New Brunswick
Posted on: December 30, 2018
This position ensures that devices and packaging used in combination products are developed and manufactured in accordance with regulatory and customer requirements. They will be responsible for Device Product Engineering and Packaging Design & Development by developing, maintaining, and improving the design controls for new drug products and lifecycle management of commercial products. Responsibilities: + Collaborate with primary container development, device development, marketing, supply chain, procurement, logistics, internal and external manufacturing sites, to successfully develop, tech transfer and launch packaged products for US and export markets that are in compliance with Design Controls, and relevant elements of the Quality System Regulations + Lead large scale commercial projects/programs in technology transfers from design center / launch site to internal BMS manufacturing sites as well as Contract Manufacturing Organizations (CMO?s) + Assist packaging development activities in specification development through human factors engineering by conducting user studies, design of experiments (DOE?s), and analysis of data using statistical tools and in-depth evaluation of variable factors. + Lead Risk Assessment activities Packaging Design, Product, and Process. Maintain Product and Process FMEAs and other risk management tools in accordance with ISO 14971 and other applicable regulations. For commercial products, provide information updates into Design History File maintained by Device Development. + Work with cross-functional teams to assist in the development of engineering studies, design verification protocols, stability studies and validation protocols, ensuring appropriate selection of acceptance criteria and sampling plans. Ensures measurement systems analysis (MSA?s) for all finished product performance test methods as needed in tech transfer or lifecycle. + Participate in design reviews and provide SME input. Review supporting documentation, approving documents as part of tech transfer, and ensure those documents are suitable to minimize risk to commercial manufacturing, supply, and patients. + Evaluate changes (component, product, process) post design transfer impact on manufacturing process, documentation and design control elements. Work with manufacturing site, Device Development, and Quality, assess risk/impact in accordance with Design Control requirements + Participate as needed on Device Quality Council, Management Reviews, Packaging Technical Forum and other teams for commercially approved combination products. Compiling and developing content cross-functionally and from stakeholders as needed. + Employs project management practices for developing project timelines, resources, monitoring progress and project status communication. + Post-market assessment leading to identification and implementation of product design improvements. This includes component specifications, test methods, and assembly processes + Support root cause analysis activities for major manufacturing investigations and product complaint trends across groups in MS&T, leading investigations related to combination products. This includes forensic analysis of complaints, Design of Experiments, and application of other engineering tools. + Assist in the development and adherence to site Validation Master Plans, and execution of Operational and Performance qualifications as well as Process Validations in accordance with established regulations and approved site and corporate standards and procedures. + Support combination product related regulatory filings pre and post approval + Support Manufacturing sites, Global Quality and Compliance in supplier, customer, internal, and/or regulatory agency audits. + Collaborate cross-functionally to promote awareness and ensure compliance to new regulatory policies, regulations, directives, and other issues that impact devices and combination products. + Actively participate in an internal and external network of experts, and industry forums, to keep the organization at the forefront of packaging development and innovation. Present at conferences to contribute innovation sharing. + Apply design controls methodology in activities in Primary Packaging, Packaging Development, Packaging Systems, and Process Engineering, with ability to flex into these adjacent areas with changing priorities. + Responsibilities also include mentoring and developing other members of the Device & Packaging Technology team in product development and design controls as well as cross training to expand knowledge in other disciplines within the group. **Education** : + BS degree in Mechanical Engineering or relevant engineering discipline. Advanced degree a plus. **Experience / Knowledge Desired:** + Minimum of 15 years of engineering experience in the Medical Device, Pharmaceutical or Biotechnology industry + Strong analytical, technical writing, interpersonal, and communication skills with ability to present internally/ externally to suppliers, sites, health authorities, and Sr. Management. + Thorough knowledge of quality systems regulations (21 CFR 820 & 211, ISO 13485), validation principles for product and manufacturing processes, design transfer, engineering design fundamentals for combination products, and packaging testing (ASTM, ISTA) + Leadership, communication and influencing skills in order to work effectively across organizational boundaries and across multiple sites/regions/levels of manufacturing sophistication. + Demonstrated ability to: + influence areas not under direct control to achieve objectives + work strategically, manage multiple programs and create a high performance work environment + work in a matrix environment and effectively support internal & external manufacturers and suppliers + build alignment with business partners and key stakeholders + manage risk and make rapid decisions + budget, plan and manage resources efficiently + Working competency of statistical programs (i.e., Minitab, SAS, etc.) + Certified Six Sigma Green/Black belt or equivalent preferred + Product Development Experience required + Human Factors Engineering experience preferred + Manufacturing Experience a plusBristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Keywords: Bristol Myers Squibb, New Brunswick , Sr Principal Engineer - Combination Products, Engineering , New Brunswick, New Jersey
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