Project Engineer

Lonza•Portsmouth, NH

1d•Onsite

About The Position

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.

Requirements

Bachelor’s degree required.
5-10 years of substantial pharmaceutical/biotechnology experience (or equivalent).
Experience in the design and operation of Biopharmaceutical facilities, both manufacturing and support systems.
Project management and coordination experience associated with the execution of capital projects in an industrial environment is required.
Practical experience in the management and coordination of engineering and construction management consultants, equipment vendors and contractors is required.
Ability to handle multiple projects simultaneously, keeping track of costs and schedule and ensuring compliance with quality and safety standards.
A solid understanding of design principles and standards within Biopharmaceutical facilities.

Nice To Haves

Preferred areas of study: Computer Science, Information Technology or an applicable Engineering discipline.
Experience with control systems (PLC, DCS, Loop controllers) desirable.

Responsibilities

Lead root cause analysis, resolve major equipment breakdowns, and sustain maintenance programs by optimizing preventative maintenance plans.
Plan and execute capital plant projects, oversee commissioning protocols, and manage engineering contractors.
Serve as the technical owner of P&IDs and process equipment, acting as the lead for new technology transfers.
Own change requests and CAPA actions, assist with deviation investigations, and lead quality risk assessments.
Review and revise SOPs, batch records, and validation protocols, while updating critical engineering documents and drawings.
Act as the engineering Subject Matter Expert (SME) during facility audits and inspections.
Demonstrate safety leadership by example and balance priorities effectively to meet project milestones and timelines.