Manufacturing Process Engineer (mRNA, Cell Therapy)
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 Process Engineer role supports ongoing operations at the Portsmouth, NH site through technical assistance as it relates to manufacturing and process systems. The focus of the role is on ensuring manufacturing equipment and facilities are operating as intended to meet the requirements for biopharmaceutical manufacturing. Responsibilities of the Process Engineering function include both tactical support of ongoing plant operations and strategic implementation of engineering projects to meet the changing needs of the business. The role reports into the Manufacturing Engineering department at the site.
- Performs all work safely and meets the requisite training requirements
- Develop technical knowledge on manufacturing equipment and processes
- Manage resolution of major equipment breakdowns and quality issues in the suites
- Provide SME support to Manufacturing and other departments for the design and operation of process equipment.
- Conduct troubleshooting and technical analyses on manufacturing equipment and processes
- Assist with tech transfer of new processes into the facility
- Modify/develop preventative maintenance plans and create spare parts
- Planning and execution of plant projects involving equipment changes and process improvements
- Execute, author and review commissioning protocols (installation, operation, CIP/SIP, wet testing)
- Own change requests and complete change request tasks to support project completion
- Assist the Quality department with deviation investigations and participate in root cause analysis investigations for equipment issues
- Assist with completion of CAPAs (Corrective and Preventative Actions) and participate in quality risk assessments
- Review/revise Engineering and Manufacturing related SOP’s, work instructions, and maintenance assessments/procedures as a result of CAPA, equipment/process changes, and error prevention activities.
- Complete engineering review/approval of batch records
- Initiate updates to Engineering documents including engineering drawings
- High School Diploma or Equivalent; BS in Engineering Discipline. Preferred area of study: Chemical Engineering
- Significant pharma/biotech experience (or equivalent).
- Practical experience in the application of engineering principles to plant systems; Biopharmaceutical/process experience preferred.
- Experience in the technical analysis of operational and design issues within an industrial environment
- Proficient with Microsoft Office Suite with focus on Outlook, Word, PowerPoint and Excel.
- Ability to effectively communicate via writing and oral communication both within the department and across departmental boundaries.
- Effective communication skills (verbal and non-verbal)
- Ability to work on multiple projects simultaneously ensuring compliance with quality and safety standards.
- Relate and compare data from different sources and identify cause and effect relationships.
- Ability to evaluate engineering problems and be able to devise cause and affect relationships and propose solutions. Communicates with other departments where needed.
- Demonstrating the proper level of detail for all aspects of the job.
- Works effectively on cross-functional teams and in a fast paced environment.
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 it is 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.