Manufacturing Execution Systems (MES) Automation Engineer Level 4 - Cell and Gene Therapy

Qualifications
Bachelor's degree in an engineering or related discipline with 5-10 years of automation experience
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
Responsibilities
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
Performs all work safely and meets the requisite training requirements
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
Act as MES engineering lead for tech transfer of new processes into the facility
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
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
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
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
Job description
Job Description

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 Automation Engineer Level 4 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.
• 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.
• Act as MES engineering lead for tech transfer of new processes into the facility.
• 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 an engineering or related discipline with 5-10 years of automation experience.
• 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, ****** orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.