Project Engineer

United States, Portsmouth (New Hampshire)

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.

The 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.

Key responsibilities:

Manufacturing Support

  • 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 (this includes covering ALT and FLT meetings as lead for team).
  • Participates in audits and inspections as engineering SME. The expectation is that you are able to speak not only to specific projects or change controls/investigations/etc., but capable of speaking to big picture, and quality systems within engineering and maintenance.
  • Able to mentor/direct plant engineers to use and understand workings of quality and business systems within the organization.
  • Responsible for identifying, managing and prioritizing own work load effectively with minimal supervision.

Supervising (as required)

  • Assign work to direct reports including new projects and initiatives, prioritize work based on business needs, impact to quality and safety, and employee development.
  • Guide direct reports through technical engineering challenges and escalation of issues Conduct regular 1-on-1’s with employees to check progress on work objectives
  • Assist with development of employees to help employees achieve career goals
  • Perform mid-year and year end performance reviews with employees
  • Accountable for technical work of direct reports
  • Manage engineering contractors to augment Lonza engineering staff

Projects

  • Planning, leading and execution of plant projects involving complex equipment changes and significant process improvements including lump sum capital projects
  • Plan, execute and lead commissioning protocols (installation, operation, CIP/SIP, 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 Engineering review/approval of deviations
  • Participate in RCAs as Engineering representative
  • Owns and executes completion of CAPA actions
  • Participates in quality risk assessments

Documentation

  • 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
  • Author and review commissioning protocols (installation, operation, CIP/SIP, wet testing).
  • Engineering approver on EDCR documents
  • Review work orders generated by Engineering

Training

  • Remain up to date on all assigned training activities including SAP Learning Portal (>90%), ComplianceWire (no overdue), iComply (no overdue), and QSMRT (attend all sessions)
  • Qualified trainer within department

Key requirements:

  • Bachelor’s degree in the field of Engineering
  • Proficient with Microsoft Office Suite with focus on Outlook, Word, PowerPoint and Excel. Proficiency with OSI PI is preferred.
  • Ability to effectively communicate via writing and oral communication at all levels to both internal and external customers. Express ideas effectively in individual and group situations (including non-verbal communication). Ability to communicate to internal and external personnel and to communicate technical information to both technical and non-technical people. Ability and willingness to express opinions and argue their basis.
  • Ability to handle multiple projects (3-5) simultaneously, keeping track of costs and schedule and ensuring compliance with quality and safety standards. Use organizational skills to prioritize and resolve project issues. Ability to evaluate solutions and recommend action based on meeting scope, schedule, and budget.
  • A good understanding of design principles and standards within Bio-pharmaceutical facilities. Ability to look at plant problems and come up with options for solutions. Understands how other departments are impacted by engineering work and proactively communicates with other departments to feed into resource planning for those departments.
  • Ability to develop alternative courses of action that are based on logical assumptions, factual data and engineering principles. The alternate actions take into consideration resources (financial and manpower), constraints and organizational priorities.

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.

Reference: R47686