MES Engineering Lvl 4 - US02 Lonza Biologics Inc.

Today, Lonza is a global leader in life sciences operating across three 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 to be part of.

This position is responsible for creation and maintenance of MES authoring principles and practices across the Lonza site in Portsmouth, NH. This position is responsible for ensuring that all projects and processes use consistent and innovative design and implementation of MES solutions. Position is expected to operate with a high degree of autonomy.

Key responsibilities:

Safety

• Performs all work safely and meets the requisite training requirements

Manufacturing Support

• Act as MES engineering lead for tech transfer of new processes into the facility
• Develop technical knowledge on manufacturing equipment and process automation systems
• Responsible for resolution of all equipment breakdowns and quality issues in the suites
• Provide SME support to Manufacturing and other departments for the design and operation of process automation equipment
• Conduct troubleshooting and technical analyses on manufacturing equipment and process automation systems including PI data analyses, CIP/SIP circuit development and review, flow path analyses, code review/troubleshooting, etc.
• Complete change request lot assessments to support lot release
• Participates in IPT/JPT meetings and customer ad hoc meetings as MES/Engineering SME
• Represents group at Engineering DMS meetings
• Participates in audits and inspections as MES SME

Projects

• Planning and execution of plant projects involving complex automation changes and significant process improvements including lump sum and CAR 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
• Performs MES review/approval of deviations
• Participate in RCAs as MES representative
• Owns and executes completion of CAPA actions
• Approver of action plans for non-regulatory CAPA
• Participates/Leads quality risk assessments

Documentation

• Review/revise MES 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, deviations, commissioning protocols, and validation protocols

Perform other duties as assigned.

• Assists in department recruiting efforts as an interviewer
• Mentors less experienced engineers in group

Key requirements:

• Bachelor’s degree in science or related discipline
• Significant Biotech manufacturing/Automation experience; Prior experience of Controls/MES protocol preferred.
• Some prior knowledge of Biotech manufacturing Controls and/or MES software preferred
• Excellent Communication Skills.
• Ability to effectively communicate via writing and oral communication at all levels. Express ideas effectively in individual and group situations (including non-verbal communication).
• Ability to communicate to internal and external personnel.
• Ability to secure relevant information and identify key issues and relationships from a base of information.
• 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 effect relationships and propose solutions.

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.