Manufacturing Project Specialist
United States, Portsmouth (New Hampshire)
Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
We have recently been confirmed as the global manufacturing partner for Moderna’s vaccine against the novel coronavirus, providing a tenfold manufacturing capacity increase. As other businesses face increasing economic uncertainty, we are fortunate to have opportunities for expansion. Through this new collaboration, our work will have a significant, direct and long-term impact on the management of this global pandemic.
The Manufacturing Project Specialist is responsible to support manufacturing in partnership with the Manufacturing Leadership Team and cross-functionally across the site. This person will work closely with Manufacturing Management to support the interdepartmental requirements and maintain due dates. The Manufacturing Project Specialist has responsibility for the planning, implementation and delivery of projects assigned. The Project Specialist supports by working cross-functionally and in collaboration with internal support departments, customers and Manufacturing suites to develop or update procedures or steps, identify and escalate risks, communicate changes and plan for execution and/or support operational readiness/tech transfer activities. The Project Specialist is responsible for owning and driving manufacturing improvement projects from concept to completion, with a particular focus on creating efficiencies that contribute to quality, cost, on-time delivery and right first time. The individual will manage a collection of projects in addition to ensuring Manufacturing Corrective and Preventative Action (CAPA) closures, Change Controls and Low Minor deviations are progressing to the agreed upon timelines. In addition to managing the timelines of the Manufacturing Quality Documents, the Project Specialists will be assigned large scope CAPA to own. The individual will be assigned Laboratory Investigation Reports perform Validation Protocol Review and various tasks to support Lot Release Requirements and continued production.
- Own and manage Mfg. process specific change controls, and CAPA’s and/or support operational readiness/tech transfer activities.
- Drive and own improvement projects that support Key Performance Indicators (KPI’s), with a focus on cost, innovation, on-time delivery and quality.
- Manage projects from concept to completion; create and manage project plan, work cross- functionally to ensure right first time and provide adequate training to impacted areas.
- Generate and Manage Metrics
- Completion of Laboratory Investigation Reports. Perform Validation Protocol Review
- Monitor Manufacturing CAPA due dates and support closure and extensions as needed
- Advanced technical knowledge of manufacturing operations (ideally all areas of manufacturing, but strong in some areas and ability to quickly learn other areas is acceptable).
- Thorough knowledge and understanding of batch records procedures, and other documentation required for manufacturing execution.
- Working knowledge and experience with Quality Systems including deviations, change controls, optical transport networks (OTNs); both the system (TrackWise) and the practical applications in operations.
- Knowledgeable in process, equipment, cleaning, and computer system validations to the extent of being able to effectively review and approve protocols and reports and support implementation of new equipment.
- Experience in various Operational Excellence tools such as Root Cause Analysis, Failure Modes and Effects Analysis, Value Stream Mapping, Kaizen, Statistical Process Control, single-minute exchange of dies (SMED), etc.
- Demonstrated ability to manage medium to large sized projects within required time frames. Experience with customer interactions, presentations
- AS/BS in Biotechnology, Biology, Chemistry, or equivalent
- Preferred area of study: Science related discipline
- High School Diploma or Equivalent may be considered with relevant experience
- Working experience in Biotechnology, preferably Upstream and Downstream, or similar Manufacturing industry. (Strong working experience without AS/BS)
- Excellent written (especially technical writing) and verbal communication skills.
- Superior planning, time management and coordination skills and be able to readily adapt to changes in priorities and project schedules.
- Attention to detail and good investigation, problem solving and organizational skills.
- Familiarity with SAP system an advantage
- Ability to work in MS Word, Excel, PowerPoint
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.