Manufacturing Project Specialist

United States, Portsmouth (New Hampshire)

Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. 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 Capital Project Manufacturing Specialist will be responsible for representing the End User as part of the Capital Project Team.  Representation includes defining User Requirement Specifications and support on design generation from Conceptual through to Detailed Design.  The Capital Project Manufacturing Specialist will be actively involved in subsequent phases of the Capital Project performing various required activities in support of equipment procurement, equipment fabrication, equipment installation, commissioning, startup, and qualification.  Responsibilities include generation of all documentation required to assure Operational Readiness of the new production suite.  Focus is on Upstream Processing.

The Project Specialist is responsible for owning and driving manufacturing improvement projects from concept to completion, with a particular focus on creating efficiencies that contribute to quality, cost, on-time delivery and right first time performance. This role may include the mentoring, management and oversight of other manufacturing Project Associates, specialists and temp labor.

Key Responsibilities

  • Own, manage and monitor: Technology transfers, campaign support and readiness, capital projects,
  • MFG process specific change controls, Corrective and Preventative Action (CAPA’s), (LIR), Validation activities.
  • Drive and own improvement internal and cross-functional projects that support department “Key Performance Indicators” KPI’s, with a focus on cost, innovation, on-time delivery and quality. Manage projects from concept to completion; create and manage project plan, work cross-functionally to ensure right first time and provide adequate training to impacted areas.
  • Mentoring individuals or teams, managing the temporary labor

Key Requirements

  • Extensive Biotechnology experience preferably Upstream, or similar Manufacturing industry
  • Significant/Strong working experience in the design and operation of Biopharmaceutical facilities, preferably Upstream Processing, in both manufacturing and support systems (cGMP manufacturing, pilot plant & laboratories). 
  • Experience with control systems (PLC, DCS, Loop controllers) desirable.
  • Experience in project management and coordination associated with the execution of capital projects in an industrial environment.
  • Preferred experience of practical experience in the management and coordination of engineering & construction management consultants, equipment vendors and contractors.
  • Candidate must be fully committed to Lonza’s adherence to Safety Regulations and Guidelines
  • Strong understanding of the fundamentals of large scale commercial mammalian cell culture processing from media preparation through harvest unit operations. 
  • Strong understanding of the latest ASME Bioprocess Equipment standard including sanitary design of equipment/piping systems and design for Cleaning in place (CIP) and Sterilization in place (SIP) design and operation.
  • Experience with design and operation of large scale Distributed Control Systems (DCS), preferably the Emerson DeltaV platform.
  • Building and Cleanroom design/construction knowledge.
  • Strong communication and project management understanding to coordinate and manage the activities of internal Lonza staff, consultants, vendors and contractors to meet scope, schedule, budget, safety and quality requirements of assigned Capital projects.
  • Team oriented individual who functions well in a Team environment and fully supports the objectives of the Project Team.
  • Ability to quickly adjust to a dynamic and fast paced environment
  • This position does not require day to day supervision. Expected to work independently to achieve specified goals. Understands business impact of decisions and applies risk assessment skills.

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: R27934