Senior Project Engineer
Lonza’s Portsmouth, NH site has had a lot of growth over the past few years, including building a fully automated manufacturing suite, and manufacturing mRNA technology for the covid19 vaccine. The site is continuing it’s growth, and looking to build teams to support upcoming expansions.
he Senior Project Engineer role supports ongoing Lonza operations by providing technical leadership as it relates to manufacturing and process systems. The role acts as a technical resource to operations customers to ensure that equipment and facilities are designed, operated, and maintained to meet production needs. Responsibilities of the role include implementation of engineering projects to support manufacturing 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 including PI data analyses, CIP/SIP circuit review, MOC analyses, flow path analyses, etc.
- Assist with tech transfer of new processes into the facility
- Modify/develop preventative maintenance plans and create spare parts
- Complete change request lot assessments to support lot release
- Participates in IPT/JPT meetings and customer ad hoc meetings as engineering SME
- Represents group at Manufacturing Engineering DMS meetings
- Participates in audits and inspections as engineering SME
- Manage engineering contractors to augment Lonza engineering staff
- Planning and execution of plant projects involving complex equipment changes and significant process improvements including lump sum capital projects
- Own change requests and complete change request tasks to support project completion
- Performs Engineering review/approval of deviations
- Participate in RCAs as Engineering representative
- Owns and executes completion of CAPA actions
- Review/revise Engineering and Manufacturing related SOP’s, work instructions, and maintenance assessments/procedures as a result of CAPA, equipment/process changes, error prevention activities, etc.
- Complete engineering review/approval of batch records, deviations, commissioning protocols, and validation protocols
- Initiate EDCRs for updates to Engineering documents including engineering drawings
- Bachelor's Degree; preferred area of study in engineering or life science.
- Experience in a GMP facility, operations and CAPEX experience preferred.
- Self Starter, shows initiative
- Pragmatic, able to troubleshoot
- Interpersonal skills, customer service skills
- Change agent, experience implementing/sustaining change
- Adaptable, open-minded
- Strong Work ethic
- Experience in biotech, biologics manufacturing.
- Familiarity with Trackwise, change controls, CAPAs
- SAP Experience
- Experience and ability to lead a team
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.