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!

KEY REQUIREMENTS:

• Bachelor’s degree in an engineering or related discipline with 5-10 years of automation experience.
• Strong technical knowledge of ME software platform(s)
• Related work experience in a GMP environment.
• 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

Safety

• Performs all work safely and meets the requisite training requirements.
• Develop technical knowledge on manufacturing equipment and process automation systems.

Process Supprt

• 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.
• Perform fixing 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/fixing, etc.
• Fulfill the position of MES engineering lead for tech transfer of new processes into the facility, with equivalent experience also being recognized.
• 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.
• Implement 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 or equivalent experience representative.
• Owns and completes 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