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 fit gap analysis / pFMEA, author / review Process Descriptions, Batch Records, Bill of Materials, etc.
- Support equipment commissioning, process training, and validation activities.
- Assist with evaluation of process requirements to ensure facility and equipment capability design can accommodate the introduction of new processes. Perform calculations to predict volume, time and process yield. Assist with evaluation of new proposals from prospective customers.
- Train manufacturing technicians in the proper and safe use of equipment to successfully run manufacturing processes
Complex Technical Investigations:
- Play a key role in resolving manufacturing technical issues to improve compliance throughout the site.
- Serve as investigation lead for process-impacting deviations and investigations.
- Plan and execute corrective actions to reduce process variability, improve product quality, or streamline production processes. Own CAPAs from start to finish, including implementation.
- Keep current with advances in technology as related to the Biosciences product lines and make recommendations to the business for continuous improvement.
- Organize, manage and improve Unit 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 ISO regulations in a timely manner, right first time in accordance with department objectives.
- Identify process improvement opportunities
- Strong experience with components, packaging, and filling within biopharmaceutical manufacturing.
- Demonstrated projects or work involving product packaging and integration in process, alternative packaging, and single use packaging.
- Bachelor’s Degree in Chemical Engineering, Mechanical Engineering, Manufacturing Engineering, or related discipline.
- Six Sigma certification preferred
- 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.
- Strong verbal and written communication skills; excellent presentation skills; Ability to professionally converse about highly technical concepts.
- 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.
- Experience using statistical tools such as Minitab, JMP, Statistica, is a plus.
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.