Allergan Technical Project Manager-Serialization in Cincinnati, Ohio
Technical Project Manager-Serialization
Cincinnati, Ohio, United States at http://agn.referrals.selectminds.com/jobs/682/other-jobs-matching/location-only
Sep 20, 2016Post Date
Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceuticals and biologic products for patients around the world.
Allergan markets a portfolio of best-in-class products that provide novel treatments for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology, anti-infective and cardiovascular therapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives.
Our success is powered by our world-class team’s commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what it is right.
Join one of the world’s fastest growing pharmaceutical companies!
At Allergan you will have the opportunity to thrive in a fast-paced, strategic environment where bold, innovative thinking isn’t just welcomed, it’s encouraged. Across all functions, we relish the opportunity to help our people fulfill their potential. Our rapid growth strategy means plenty of opportunities to step into the spotlight.
The Technical Project Manager-Serialization will have a primary responsibility to provide leadership to the implementation, operationalization and performance of the site serialization systems. The incumbent will provide necessary leadership to local resources to ensure success.
The Technical Project Manager-Serialization will coordinate capital planning, monitoring, long range planning and site master planning aligned with the strategic direction of Allergan.
The Technical Project Manager-Serialization Technical Project Manager-Serializationwill collaborate with the corporate serialization group to develop best practices and sound engineering principles. The incumbent will also provide routine reporting to site and corporate leadership as well as keep aware of regulatory changes or updates that impact the site.
The incumbent will have experience working in the pharmaceutical manufacturing setting with demonstrated success in a cross-functional team environment. This role includes collaboration with manufacturing, finance, engineering, IT and quality functional resources.
• Lead and direct site teams, ensuring successful implementation of key capital projects as well as development and implementation of strategic programs in support of the sites manufacturing and supply chain network.
• Implement strategic project plans that align to global strategic direction and utilize tracking tools to forecast / remediate risks and issues to timelines
• Contribute to or develop User Requirement Specifications, Functional Requirement Specifications, Design Specifications/Qualifications, Factory and Site Acceptance Tests, Machinability Studies and Standard Operating Procedures as necessary for new and modified equipment.
• Support of IQ, OQ& PQ validation Activities
• Understand and educate site stakeholders on serialization requirements and associated impacts to current and future state operations
• Responsible for specifying, developing and implementing serialization solutions to existing and new automated equipment
• Support development of business processes and procedures to support serialized packaging operation.
• Work with site resources to coordinate conversion of SKUs to serialized production.
• Maintain and provide baseline knowledge of site IT infrastructure to support integration projects between site lines / systems and corporate initiatives
• Interacts with suppliers addressing interfacing and communication issues throughout the development process.
• Drive installations and/or modifications, including vendor selection, procurement of equipment or services, scheduling, vendor coordination, set-up, start-up, troubleshooting, de-bugging, and training
• Provide troubleshooting support and develop solutions for systems in operation
Education and Experience:
• Bachelor’s degree in engineering or related field; specifically Electrical, Chemical or Mechanical. Controls engineering preferred or equivalent industry experience.
• Demonstrated project management experience
• Demonstrated technical writing and documentation skills.
• Technical training in pharmaceutical design (i.e.packaging).
• 3 - 5 years pharmaceutical industry experience
• Project Engineering, process design, equipment selection, cost estimating scheduling and people management experience are required.
• Excellent communications skills in oral, written, and presentation situations providing clear, informative, and persuasive communication in positive and negative scenarios.
• Must be familiar with regulated industry, CGMP, GAMP, 21CFR Part 11 and industry best practices
• Must have knowledge and experience in vision inspection systems
• Must have knowledge of Microsoft Word and Excel.
• Previous experience working with serialization requirements and implementing in a manufacturing environment
• Familiarity with GS1 and HDMA guidelines as well as key serialization vendors is preferred
• Knowledge and experience of integrated solution for track and trace packaging line equipment and serialization solutions
• Knowledge on computerized systems with data collection software (Database), network communications protocols
• Knowledge Optel, Tracelink or evquivalent stronly perferred
• Basic knowledge in SAP systems,OPTEL, Tracelink or equivalent strongly preferred
• MS Project