Manufacturing Science and Technology Engineer, Bioscience
United States, Walkersville (Maryland)
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.
Do you enjoy analyzing complex information and tackling problems head-on to devise effective solutions? If this sounds like you, Lonza Bioscience is actively seeking a Manufacturing Science and Technology (MSAT) Engineer to join our team in Walkersville, MD.
Your strong problem solving skills will allow you to successful performing technical investigations, process and/or equipment troubleshooting identifying opportunities for process improvement, design and implement corrective and preventive actions using Quality System tools, and provide technical expertise to multi-departmental teams.
In this role, you will be responsible for ensuring the successful tech-transfer and continued technical support Lonza Bioscience processes and equipment in order to meet established timelines and quality objectives.
Using your ability to build strong relationships, you will work across functions such as Manufacturing, Research and Development (R&D), Program Management, Quality Control, Marketing, and Quality to successfully transfer processes and systems into Manufacturing.
- Perform all functions associated with process transfer and scale up to manufacturing e.g., develop process understanding, perform gap analysis / FMEA, generate process models, author / review Process Descriptions and Batch Records, support equipment commissioning, process training, and validation activities.
- Assist with evaluation of process requirements to ensure facility and equipment capability design can accommodate. Perform calculations to predict volume, time and yield projections. Assist with evaluation of new proposals from prospective customers.
- Provide process equipment troubleshooting to resolve issues that may arise during a manufacturing campaign. Initiate and drive equipment utility change controls to ensure equipment is implemented or repaired within required timeframes.
- Lead in the design, fabrication, integration, and installation of process lines to manufacture products reliably and within design specifications.
- Train manufacturing technicians in the proper and safe use of equipment
- As needed, interface with customer technical and quality representatives, represent MSAT group in Project Teams.
- Work directly with Manufacturing, Project Management, Marketing, Supply Chain and R&T and Marketing to develop a bill of materials, to assist in part set-up and write the transfer documents as needed for an incoming process.
- Perform all functions associated with process monitoring and lot releases e.g. manufacturing data summary and analysis, data presentation; author campaign summary reports, assess deviations and process changes.
- Play a key role in resolving technical issues for all functions to improve compliance throughout the site. Serve as investigation lead for process-impacting deviations and investigations. Provide technical guidance on change controls and how they might impact the processes and product specifications.
- Keep current with advances in technology as related to the Biosciences product lines.
- Plan and execute corrective actions to reduce process variability, improve product quality, or streamline production processes. Own CAPAs from start to finish, including implementation.
- Organize, manage and improve Operations activities in support of the development of new products or processes and the manufacture of clinical and commercial products according to cGMPs and/or ISP regulations in a timely manner, right first time in accordance with department objectives.
- Communicate and coordinate clearly / extensively internally with other departments and all stakeholders to drive project completion.
- Bachelor’s Degree in Chemical Engineering, Mechanical Engineering, Manufacturing Engineering, or related discipline Significant experience in a manufacturing environment involved in process/manufacturing engineering and/or equipment design
- Familiarity with large scale manufacturing, current Good Manufacturing Practices (cGMP), ISO regulations, and US / EU regulations
- Advanced knowledge of biopharmaceutical manufacturing such as lyophilization, formulation, filling operations, biochemical assays, cell culture, cell isolation, sterile manufacturing, depyrogenation, media powder and liquid composition, automated manufacturing, packaging, labeling, and aseptic technique.
- Ability to professionally converse about highly technical concepts. Strong verbal and written communication skills; excellent presentation skills
- Experience and knowledge of disposable and single use systems used in bioprocessing
- Analytical ability, both interpersonal and issue-related; good judgment and ethics; professional demeanor.
- Proven leadership ability, especially with indirect reports. Ability to coordinate, facilitate and organize resources.
- Proven ability to perform root cause analysis, FMEA, and develop corrective and preventive actions to reduce likelihood of recurrence.
- Able to independently monitor, analyze and report on problem record trends for the functional areas to reduce non-conformances
- Strong, customer focused orientation with solid follow-up skills and attention to detail.
- Self-motivated, strong work ethic, and ability to “get the job done” and take responsibility for results without direct authority.
- Must possess excellent writing and PC skills with a knowledge base in Microsoft Word, Excel, Power Point, and Project.
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
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.