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.

Lonza Walkersville Maryland is a 24-5 operation that has 3 shifts 1st shift is 7am-3pm, 2nd shift is 3pm-11pm, and 3rd shift is 11pm-7am. There could be a slight variation of these timeframes. We do offer shift differentials for 2nd and 3rd shift. There are 4 areas of responsibilities that we have and you would be assigned to one of these areas of interest.

Fill /Finish

Key Responsibilities:

• Responsible for executing aseptic processing in a clean room environment adhering to Standard Operating Procedures.
• Complete documentation concurrently with completion of manufacturing processes.
• Responsible for performing personal and environmental monitoring.
• Be able to gown aseptically and work in an aseptic environment.
• Process production batches in a LFBSC.
• Responsible for filling vials ranging from .2mL to 60ml.
• Responsible for filling bottles ranging from 100 mL to 1L.
• Responsible for filling sterile bags ranging from 250mL to 20L.
• Responsible for final product packaging of bottles, bags, vials (boxing).
• Responsible for completing assigned tasks (for example, cleaning, lab setup etc.) related to departmental functions.
• Perform preventative maintenance and general upkeep on equipment and facilities including environmental monitoring.
• Responsible for reviewing SOPs, MBRs and other associated forms for revision; Revise SOPs, Batch Records or other documentation as needed.
• Review and sign manufacturing batch records.
• Assist in training entry level staff members.
• Being available for business necessitated overtime is required.
• Perform other duties as assigned.
• *This position primarily encompasses with the various roles (Vialer, assistant, perform environmental monitoring) in the cleanroom to fill bulk media into bottles, bags, vials; Most employees spend the majority of their day in a cleanroom environment*.
• Must be able to lift 50 pounds repeatedly and stand for long periods of time.

Liquid Media

Key responsibilities:

• Formulates liquid media products using an Electronic Batch Record.
• Formulates liquid media products using a Paper Batch Record.
• Weighs materials using various size balances.
• Operates various lab equipment: pH meter, Osmometer, Balance, Water Bath
• Performs sterile filtration in a class 100 LFBSC
• Orders and maintains adequate levels of production and laboratory supplies
• Hot Rinses formulation tanks
• Maintains a clean and orderly area. Completes cleaning logs
• Operating in a safe work culture (safety chats, safety and EPS observations, 6S)
• Completion of LAL Cleanroom General Training
• Aseptic processing/gowning
• Cleanroom Equipment Set-Up and Usage
• Environmental Monitoring
• Qualification of SAP Transactions (COR3, COR6, MIGO, LS26)
• Completion of LAL Finishing General Training
• Finishing Equipment Set-Up and Usage
• Qualification of SAP Transactions (COR2, COR6, MIGO, MB1A, LB01, LS26)
• GMP Documentation practices
• Product Sample Submission
• Inspection Proficiency Testing
• Inspection Process
• Component Kitting Process
• Continuous Improvement Projects
• Perform job functions with minimal operator related PRs
• Perform aseptic processing with minimal operator related personnel excursions (EM)
• Understand basic level of LAL process flow
• Achieve yearly personnel utilization target
• Maintain training compliance to meet yearly target
• Must be able to demonstrate GMP documentation practices (minimal document errors)
• Must be able to follow standard operating procedures and complete production records
• Understand compliance in the execution of GMPs in a manufacturing environment

Powder media

Key responsibilities:

• Be able to gown aseptically and work in an aseptic environment.
• Perform cleaning of production tanks and associated equipment.
• Responsible for formulation of bulk productions and stock solutions.
• Complete tasks (cleaning, lab setup) related to departmental functions.
• Maintenance on equipment and environmental Monitoring
• Review SOPs, MBRs and other forms for revision; Revise SOPs, and Batch Records.
• Review and sign manufacturing batch records.
• Responsible for keeping current on all job relevant trainings.
• Maintain accurate production bin inventory in responsible area.
• Assist in writing deviations and supporting investigations.
• Assist in training entry level staff members.

Formulation/Filtration

Key responsibilities:

• Formulates liquid media products using an Electronic Batch Record or paper Batch Record.
• Hot Rinses and Cleans all production equipment, including tanks and drum filler.
• Perform integrity testing of filters and prepare filling assemblies for sterilization.
• Operates various lab equipment: pH meter, Osmometer, Balances, Water Baths, Microfluidizer, Conductivity Meter, UltraFilter
• Operate Delta V HMI for formulation and cleaning processes in new suites.
• Ensures accurate completion of documentation for all Formulation/Filtration related documents.
• Perform production area and associated equipment recovery activities such as cleaning of rooms, filler, miscellaneous equipment, etc.

Key requirements for the role:

• High School Diploma or GED is required; Bachelor’s degree in a life sciences, engineering or related field is preferred
• Working manufacturing or technical skills are required
• Questioning attitude to drive problem solving
• Ability to collaborate with cross-functional teams
• Ability to communicate effectively to share learning and provide training to manufacturing
• Must have the ability to work in a fast paced, high workload environment.
• Must be able to read and follow defined SOPs and policies, work independently and as part of a team on various manufacturing tasks, identify and communicate non-routine events.
• Must be proactive, action oriented, and have the ability to adapt to a change.
• Must have strong communication skills both verbally and written.
• Must be able to support other members of the team through mentoring and training.

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: R43032

Similar Jobs