Technician II, Central Services

Catalent•Harmans, MD

3d•$24 - $29•Onsite

About The Position

We have an opportunity for a Technician II, Central Services to join our team. In this role, you will support manufacturing processes in Central Services by applying broad knowledge of theories and principles to solve operational and routine tasks. You will contribute to the production of bulk biologics from microbial and cell culture systems for Phase I/II and commercial GMP manufacturing. This position reports to the Central Services Supervisor assigned to the shift. Shift work and weekend work may be required at times. Shift: Day shift 7am-7pm on a 2-2-3 rotation Location: Harmans, MD - BWI 100% Onsite

Requirements

High School diploma or GED with 2-4 years of experience in upstream (fermentation/bioreactor) or downstream (column chromatography, buffer/media skid) biologic production processes under GMP compliance preferred
Associate degree in a Scientific, Engineering, or Biotech field with 2-4 years of experience in upstream or downstream biologic production processes under GMP compliance preferred
Bachelor’s degree in a Scientific, Engineering, or Biotech field with 1-3 years of experience in upstream or downstream biologic production processes under GMP compliance preferred
Strong knowledge and ability to apply scientific principles to solve operational and routine production tasks
Excellent documentation skills including comprehension, review, and establishing Batch Production Records, Standard Operating Procedures, deviations, and summary reports
Thorough knowledge of current Good Manufacturing Practices and relevant safety procedures; general understanding of most areas in Manufacturing and supporting functional groups
Strong team player with excellent written and verbal communication skills, able to build and maintain effective cross-functional relationships across departments and support functions.
Flexible, adaptable, and self-motivated professional with basic knowledge of Quality Control, Quality Assurance, Regulatory, and Materials Management, as well as proficiency with Microsoft Office and the ability to work independently or collaboratively.
Ability to perform physical job requirements, including extended periods of standing, walking, and bending, lifting up to 25 lbs, and wearing a Powered Air Purifying Respirator (PAPR) when handling certain chemicals.

Nice To Haves

Experience with Media and/or Buffer Preparation

Responsibilities

Complete and maintain Batch Production Records and GMP documentation in compliance with SOPs, regulatory requirements, and data integrity standards.
Author, revise, and manage manufacturing documentation, including SOPs, batch records, protocols, deviations, CAPAs, and summary reports.
Support technology transfer activities by partnering with Process Development and MS&T teams to introduce new processes into GMP manufacturing.
Initiate, investigate, and close deviations and CAPAs, including leading root cause investigations and implementing corrective actions.
Troubleshoot manufacturing processes and equipment issues while coordinating with Facilities, Engineering, and Validation teams to ensure operational readiness.
Collaborate with production leadership to develop, optimize, and implement manufacturing processes that meet operational objectives and timelines.
Recommend and support procurement of manufacturing equipment, supplies, and resources to enhance production efficiency.
Participate in facility expansion, equipment qualification, validation, and continuous improvement initiatives.
Perform and oversee cleaning and maintenance activities for manufacturing equipment and controlled production environments.
Partner cross-functionally with internal teams and external clients during manufacturing campaigns, providing technical support, project coordination, and operational expertise.
Perform other duties as assigned