Manufacturing Execution Systems (MES) Engineer - Cell and Gene Therapy
Lonza
Farmington NH 03835 US
United States, Portsmouth (New Hampshire)
Today, Lonza is a global leader in life sciences operating across five continents. 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 you to be part of.
Location: Portsmouth, NH Hybrid
The MES Engineer Level 2 is responsible for supporting activities such as requirements gathering, testing, implementation and use of Manufacturing Execution Systems (MES). Position is expected to operate with some supervision and some autonomy.
Key Responsibilities:
Safety
• Performs all work safely and meets the requisite training requirements Manufacturing Support.
• Develop technical knowledge on manufacturing equipment and process automation systems.
• Manage resolution of 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 process control systems including PI data analyses, CIP/SIP circuit review, flow path analyses, code review/troubleshooting, etc.
• Assist with tech transfer of new processes into the facility.
• Complete change request lot assessments to support lot release.
• Participates in IPT/JPT meetings as MES representative.
Projects
• Planning and execution of plant projects involving automation changes and process improvements including lump sum capital projects.
• Execute test scripts (design, execution, simulation, wet testing).
• Own change requests and complete change request tasks to support project completion
• Perform change request assessments.
Deviations / RCAs
• Assist the Quality department with deviation investigations.
• Participate in RCAs as MES representative.
• Assist with completion of CAPA actions.
• Participates in quality risk assessments.
Documentation
• Review/revise automation and Manufacturing related SOP’s, Functional Specifications, and work instructions as a result of CAPA, equipment/process changes, error prevention activities, etc.
• Complete MES review/approval of batch records • Author and review test protocols.
• Perform other duties as assigned.
Key Requirements:
Bachelor's degree in an engineering or related discipline.
Related work experience in a GMP environment.
Strong communication and leadership skills.
Ability to secure relevant information and identify key issues and relationships from a base of information.
Ability to evaluate engineering problems and be able to devise cause and effect relationships and propose solutions.
Ability to fulfill on-call hours requirements.
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.
Reference: R63597
Today, Lonza is a global leader in life sciences operating across five continents. 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 you to be part of.
Location: Portsmouth, NH Hybrid
The MES Engineer Level 2 is responsible for supporting activities such as requirements gathering, testing, implementation and use of Manufacturing Execution Systems (MES). Position is expected to operate with some supervision and some autonomy.
Key Responsibilities:
Safety
• Performs all work safely and meets the requisite training requirements Manufacturing Support.
• Develop technical knowledge on manufacturing equipment and process automation systems.
• Manage resolution of 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 process control systems including PI data analyses, CIP/SIP circuit review, flow path analyses, code review/troubleshooting, etc.
• Assist with tech transfer of new processes into the facility.
• Complete change request lot assessments to support lot release.
• Participates in IPT/JPT meetings as MES representative.
Projects
• Planning and execution of plant projects involving automation changes and process improvements including lump sum capital projects.
• Execute test scripts (design, execution, simulation, wet testing).
• Own change requests and complete change request tasks to support project completion
• Perform change request assessments.
Deviations / RCAs
• Assist the Quality department with deviation investigations.
• Participate in RCAs as MES representative.
• Assist with completion of CAPA actions.
• Participates in quality risk assessments.
Documentation
• Review/revise automation and Manufacturing related SOP’s, Functional Specifications, and work instructions as a result of CAPA, equipment/process changes, error prevention activities, etc.
• Complete MES review/approval of batch records • Author and review test protocols.
• Perform other duties as assigned.
Key Requirements:
Bachelor's degree in an engineering or related discipline.
Related work experience in a GMP environment.
Strong communication and leadership skills.
Ability to secure relevant information and identify key issues and relationships from a base of information.
Ability to evaluate engineering problems and be able to devise cause and effect relationships and propose solutions.
Ability to fulfill on-call hours requirements.
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.
Reference: R63597