Manufacturing Project Specialist- Midscale

2 weeks ago

Portsmouth, Virginia, United States Lonza Full time
Manufacturing Project Specialist

  • Midscale
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 Manufacturing Project Specialist is responsible to support manufacturing in partnership with the Manufacturing Leadership Team and cross-functionally across the site.

This person will work closely with Manufacturing Management to support the interdepartmental requirements and maintain due dates. The Manufacturing Project Specialist has responsibility for the planning, implementation and delivery of projects assigned.

The Project Specialist supports by working cross-functionally and in collaboration with internal support departments, customers and Manufacturing suites to develop or update procedures or steps, identify and escalate risks, communicate changes and plan for execution and/or support operational readiness/tech transfer activities.


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.

The individual will manage a collection of projects in addition to ensuring Manufacturing Corrective and Preventative Action (CAPA) closures, Change Controls and Low Minor deviations are progressing to the agreed upon timelines.


In addition to managing the timelines of the Manufacturing Quality Documents, the Project Specialists will be assigned large scope CAPA to own.

The individual will be assigned Laboratory Investigation Reports perform Validation Protocol Review and various tasks to support Lot Release Requirements and continued production.

Key Responsibilities

  • Own and manage manufacturing process specific change controls, and CAPA's and/or support operational readiness/tech transfer activities.
  • Drive and own improvement projects that support Key Performance Indicators (KPI's), with a focus on cost, innovation, ontime 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.

  • Generate and Manage Metrics
  • Completion of Laboratory Investigation Reports. Perform Validation Protocol Review
  • Monitor Manufacturing CAPA due dates and support closure and extensions as needed
  • Advanced technical knowledge of manufacturing operations (ideally all areas of manufacturing, but strong in some areas and ability to quickly learn other areas is acceptable).
  • Thorough knowledge and understanding of batch records procedures, and other documentation required for manufacturing execution.
  • Knowledgeable in process, equipment, cleaning, and computer system validations to the extent of being able to effectively review and approve protocols and reports and support implementation of new equipment.
  • Experience in various Operational Excellence tools such as Root Cause Analysis, Failure Modes and Effects Analysis, Value Stream Mapping, Kaizen, Statistical Process Control, singleminute exchange of dies (SMED), etc.
  • Demonstrated ability to manage medium to large sized projects within required time frames. Experience with customer interactions, presentations.

Key Requirements:

  • AS/BS in Biotechnology, Biology, Chemistry, or equivalent
  • Preferred area of study: Science related discipline
  • High School Diploma or Equivalent may be considered with relevant experience.
  • Working experience in Biotechnology, preferably Upstream and Downstream, or similar Manufacturing industry. (Strong working experience without AS/BS)
  • Excellent written (especially technical writing) and verbal communication skills.
  • Superior planning, time management and coordination skills and be able to readily adapt to changes in priorities and project schedules.
  • Attention to detail and good investigation, problem solving and organizational skills.
  • Familiarity with SAP system an advantage
  • Ability to work in MS Word, Excel, PowerPoint
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 s

  • Manufacturing Project Specialist Midscale

    1 month ago

    Portsmouth, Virginia, United States Lonza Full time

    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,...

  • Manufacturing Project Specialist Midscale

    4 weeks ago

    Portsmouth, Virginia, United States Lonza Full time

    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,...

  • Manufacturing Engineer

    2 weeks ago

    Portsmouth, Virginia, United States Laborie Full time

    We believe that great healthcare is an essential safeguard of human dignity. At Laborie, we know the work we do matters its what fuels our motivation and contributes to our success. If youre ready to make a positive impact in the lives of patients across the globe, wed like to meet you. We support and empower our employees to grow their careers in an...

  • Manufacturing Engineer

    4 weeks ago

    Portsmouth, Virginia, United States Michael Page Full time

    About Our Client My client is a global company in the defense industry. This company has great benefits including a comprehensive benefits package, 401K with company match, tuition reimbursement, quarterly bonuses and more. Job Description Reporting directly into the Manufacturing Engineering Manager, you will be responsible for:Working on complex...

  • Manufacturing Engineer

    1 month ago

    Portsmouth, Virginia, United States Michael Page Full time

    About Our Client My client is a global company in the defense industry. This company has great benefits including a comprehensive benefits package, 401K with company match, tuition reimbursement, quarterly bonuses and more. Job Description Reporting directly into the Manufacturing Engineering Manager, you will be responsible for:Working on complex...

  • Project Engineer, Cell

    2 weeks ago

    Portsmouth, Virginia, United States Lonza America, Inc. Full time

    The Project Engineer role supports ongoing operations at the Portsmouth, NH site through technical assistance as it relates to manufacturing and process systems. The focus of the role is on ensuring manufacturing equipment and facilities are operatin Project Engineer, Engineer, Process Engineer, Project Management, Operations, Equipment

  • Manufacturing/Production Supervisor

    2 weeks ago

    Portsmouth, Virginia, United States Raytheon Technologies Full time

    Work with a Leading Aerospace and Defense Company Raytheon is dedicated to defending freedoms and deterring aggression for our nation and allies. With over 100 years of experience and top engineering expertise, we aim to create a safer and more secure world by solving challenging problems. Position Overview: Manufacturing/Production Supervisor (Onsite) As a...

  • Senior Regulatory Affairs Specialist

    2 weeks ago

    Portsmouth, Virginia, United States Laborie Full time

    We believe that great healthcare is an essential safeguard of human dignity. At Laborie, we know the work we do matters its what fuels our motivation and contributes to our success. If youre ready to make a positive impact in the lives of patients across the globe, wed like to meet you. We support and empower our employees to grow their careers in an...

  • Senior Regulatory Affairs Specialist

    2 weeks ago

    Portsmouth, Virginia, United States Laborie Full time

    We believe that great healthcare is an essential safeguard of human dignity.At Laborie, we know the work we do matters – it's what fuels our motivation and contributes to our success. If you're ready to make a positive impact in the lives of patients across the globe, we'd like to meet you.We support and empower our employees to grow their careers in an...

  • Quality Control Sample Management Specialist- 2nd Shift

    2 weeks ago

    Portsmouth, Virginia, United States Lonza America, Inc. Full time

    Lonza in Portsmouth, NH is searching for a Quality Control (QC) Laboratory Sample Management Specialist to join our QC team. As our QC Sample Management Specialist, you will support the Quality Control group by managing samples, cell banks and docume Quality Control, Management, Specialist, 2nd Shift, Control, Samples, Manufacturing

  • Manufacturing Associate Biotechnologist Max 27hr W2

    4 weeks ago

    Portsmouth, Virginia, United States Lenmar Consulting Inc. Full time

    Job DescriptionNIGHTS SHIFT - 7PM-7AM - 12 HOUR SHIFTSBiotechnologist Associate - Manufacturing AssociateThe Manufacturing Associate is responsible for the manufacturing of therapeutic proteins (API) under cGMP conditions.Associates are expected to execute process recipes, follow written procedures (SOPs), monitor equipment and processes, perform basic...

  • Manufacturing Associate Biotechnologist Max 27hr W2

    2 months ago

    Portsmouth, Virginia, United States Lenmar Consulting Inc. Full time

    Job DescriptionNIGHTS SHIFT - 7PM-7AM - 12 HOUR SHIFTSBiotechnologist Associate - Manufacturing AssociateThe Manufacturing Associate is responsible for the manufacturing of therapeutic proteins (API) under cGMP conditions.Associates are expected to execute process recipes, follow written procedures (SOPs), monitor equipment and processes, perform basic...

  • QA Project Manager

    2 weeks ago

    Portsmouth, Virginia, United States Lonza Full time

    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,...

  • Customer Service Specialist

    2 weeks ago

    Portsmouth, Virginia, United States First Citizens Full time

    **Customer Service Specialist** CAROUSEL_PARAGRAPH 11034 155 Commerce Way Portsmouth, New Hampshire CIT-OPERATIONS Monday - Friday Meghan Hicking Internal/External ** Share Job** mail_outlineGet future jobs matching this search or ** Job Description** **Overview** Responsibilities for the Customer Service Specialist at Small Business Solutions include...

  • IT Cybersecurity Specialist

    4 days ago

    Portsmouth, Virginia, United States U.S. Coast Guard Full time

    You will serve as an Information Technology Cybersecurity Specialist (INFOSEC), directly managing information technology projects.Being a CG civilian makes you a valuable member of the CG teamTypical work assignments include:Developing procedures to ensure information systems reliability and accessibility to prevent and defend against unauthorized access to...

  • ECMO Specialist PRN

    4 weeks ago

    Portsmouth, Virginia, United States HCA Healthcare Full time

    Description IntroductionDo you have the career opportunities as an ECMO Specialist PRN you want with your current employer? We have an exciting opportunity for you to join Portsmouth Regional Hospital which is part of the nations leading provider of healthcare services, HCA Healthcare.BenefitsPortsmouth Regional Hospital, offers a total rewards package that...

  • ECMO Specialist PRN

    1 month ago

    Portsmouth, Virginia, United States HCA Healthcare Full time

    Description IntroductionDo you have the career opportunities as an ECMO Specialist PRN you want with your current employer? We have an exciting opportunity for you to join Portsmouth Regional Hospital which is part of the nations leading provider of healthcare services, HCA Healthcare.BenefitsPortsmouth Regional Hospital, offers a total rewards package that...

  • Quality Control Sample Management Specialist- 2nd Shift

    2 weeks ago

    Portsmouth, Virginia, United States Lonza Full time

    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,...

  • Automation Process Controller

    2 weeks ago

    Portsmouth, Virginia, United States Lineage Logistics Full time

    Welcome to our company!We are looking for a Process Control Specialist to oversee and supervise all warehouse operations to guarantee accuracy, efficiency, and timely completion. Your main responsibilities will include:Planning and monitoring all warehouse processes virtually to ensure smooth operations.Optimizing product flow to meet operational...

  • Product Demonstrator

    2 weeks ago

    Portsmouth, Virginia, United States Connexion Systems & Engineering, Inc. Full time

    Job DescriptionJob DescriptionAbout the JobAs a Customer Onboarding Specialist, you are the first interaction our end users have with the product. This role will be primarily focused on ensuring that our end users have all of the tools and training needed to turn their sign into a best-in-class advertising tool. You will also work cross-functionally, through...