The Medical Device Process Technology Specialist provides manufacturing and technology support to the Albany ThermaCare production and packaging operations. The role focuses on authoring qualification documents that assist in improving process, technical, and technology capabilities. Success in the role is achieved through development of site Manufacturing Investigation Reports, QTS commitment execution, supporting development and execution of New Product Launch and technology transfer plans, IQ/OQ/PQ validation activities, and the authoring, execution andtraining of standard operating procedures. The selected candidate works in partnership with the site Operations, Engineering, Quality, Procurement, and Operational Excellence teams under the leadership of the site Process Technology Specialist to deliver integrated technical services to meet the site objectives.
Role • Authors qualification documents in support of the site business strategy. • Resolves complex technical problems. • Identifies high-risk areas, areas of improvement and utilization of resources in specific production practices and processes. Determines the path forward through in-depth assessment, experimental testing, and complex data analysis. Develops and implements tactical solutions to mitigate impact and improve yield and effectiveness. • Works with continued process verification activities related to technology transfer of new products to the site as well as updates/optimization of existing commercial products. • Manages conflicting priorities of process improvements, production demands, compliance requirements, and time limitations. • Leads the execution of technical projects to accomplish management directives. Interprets process data for improvement opportunities and identifies and implements value-added solutions to mitigate risk and improve process capability and compliance. • Responsible for the implementation of validations and investigations within the manufacturing site. • Collaborates with various groups within Angelini during the various stages of new product development / technology transfer and develops / leads the site activities for qualification. • Collects and coordinates the combined input from different functional areas regarding the application of technologies that will optimize capital investment to provide robust, productive, and practical processes at a commercial scale. • Responsible for the implementation of Process Analytical Technologies enhancing monitoring and control.
Professional Profile: • Bachelor's Degree in Business, Technical or Scientific Discipline or equivalent experience with continuous non-woven cell pack manufacturing. • Minimum of 3 years of successful and demonstrated experience supporting manufacturing in a GMP regulated environment. • Has strong subject matter expertise in relevant areas of continuous manufacturing operations, etc. or has broad technical knowledge of industrial operations. Keeps abreast of current developments and trends in areas of expertise. Assimilates and applies new job-related information that may vary in complexity within a reasonable timeframe. • Picks up on technical aspects; can learn new skills and knowledge; fast learner. • Excellent interpersonal, written, and verbal communication skills. • Knowledge in Lean and Six Sigma principles highly desirable. • Strong Customer service and communication skills. • Action oriented with a strong sense of urgency. • Must be well organized and detail oriented while applying sound judgment and decision-making skills to both routine and non-routine issues that arise. • Able to proactively manage multiple projects and priorities and organize time effectively. • Understands Regulatory and Production requirements inherent to medical device manufacturing. • Open minded and flexible, able to understand other cultures.
Angelini Pharma is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity and/or expression, sexual orientation, national origin, genetics, disability, age or veteran status.
About Us: Angelini is a medium size private international group, a leader in health and wellness in the field of pharmaceutical and consumer products. Born in Italy in the early twentieth century, the Angelini group has offices in 17 countries and worldwide distribution of products. Angelini Pharma Inc. is the US business unit, headquartered in Rockville, MD. In 2020 Angelini Pharma Inc. acquired the ThermaCare production facility in Albany, GA.