The Sr. Process Engineer-Sterilization Synergy Projects is located at BD Covington Operations in Covington, GA.
This position is responsible for technical execution of activities associated with synergy projects in the global sterilization network to improve operational efficiency, ensure predictable product flow, and enable lowest total cost of ownership. Accountable for assigned project technical writing of protocols, execution of study activities, data analysis and reporting to ensure delivery of synergy commitments within defined success criteria.
Key role in execution of the sterilization synergy projects for technical inputs and requirements to ensure meeting the synergy targets as well as allowing current technical resources to support the ongoing business demand. Supports strategic initiatives related to sterilization strategy (network/process optimization, validation, technology, cost). Enable delivery of $10M in synergy over 2.5 years.
Reponsible for technical writing and data analysis for study protocols and reports for projects associated with the BD Sterilization Strategy.
Responsible for working with global sterilization, facilities QA/Ops and regional sterilization resources to obtain required smaples for validation testing and submittion to the laboratory to support synergy projects. Review and approve validation study results and documetnation.
Responsible for workign with global sterilization, facility quality/opos, supply chain and retional sterilization resources to assist with development of project charters, quality plans, quality agreements, and other relevant documents.
Provide assistance with preparation and/or provide technical information to complete ACR submissions and assist with regulator filings.
May perform other duties as assigned.
BS/BA in engineering, science or related field
ASQ CQE (preferred)
3+ years in medical device sterility assurance, sterilization operations or testing environment
In depth knowledge of industrial sterilization modalities (i.e. Ethylene Oxide, Radiation, Dry Head and Moist Head sterilization)
Expert knowledge of GMP compliance (FDA, BS/EN, ANVISA, etc.) and industry standards (ISO/AAMI, etc) related to sterilization validation and routine control.
Must be able to read and comprehend simple instructions in Basic English and write project justification documentation, correspondence / memos email. Must be able to effectively present information in one-on-one and small group situations to staff, internal customers and other employees within the organization.
Ability to apply mathematical concepts such as geometry, trigonometry, exponents, etc. Ability to apply mathematical operations to tasks such as facility design, process line location and layout. Skills necessary to specify and organize performance metrics to measure and evaluate process/cost performance improvement opportunities. Ability to determine, propose and articulate such improvement opportunities to peers and management. Finally to demonstrate end results of such opportunities.
Position requires good logic and reasoning ability. Ability to define problems and find logical solutions. Ability to interpret specifications and technical instructions. In summary, position requires a high degree of logical analyzing. Errors in the facility or process design bring heavy liability and financial burden to the Company. Errors in safety equipment could bring loss of life. Position interfaces heavily with outside
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to use hands to finger, handle or feel. The employee is occasionally required to stand and reach with hands and arms and lift and/or move up to ten pounds. Employee is required to meet with other personnel in other areas of building. Specific vision abilities required by this job include close vision.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
During the performance of this job, the employee may be in hot and humid locations, near moving mechanical parts, high places, risk of electrical shock, work with explosive gas, toxic and caustic chemicals, or experience loud noise (maintenance shop, forklift equipment, and construction). Must be available for “on call” activities.