GMP Biotech Technician II – Central Services

Catalent Pharma Solutions; Glen Burnie (MD); On-site; USD 33,000 - 40,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

Tuition Reimbursement

Job summary

Catalent Pharma Solutions is seeking a Technician II, Central Services in Harmans, MD. The role supports manufacturing by applying broad scientific principles to operations in central services, contributing to bulk biologics production for Phase I/II and commercial GMP manufacturing.

Shift: Day 7am-7pm, 2-2-3 rotation, 100% onsite. The candidate will manage batch records, SOPs, deviations, CAPAs, and collaboration with Process Development and MS&T to implement new GMP processes, while

Qualifications

• High School diploma or GED with 2-4 years of GMP-compliant upstream or downstream biologic production experience preferred
• Associate degree with 2-4 years GMP experience preferred
• Bachelor’s degree with 1-3 years GMP experience preferred

Responsibilities

• Complete and maintain Batch Production Records and GMP documentation
• Author, revise, and manage SOPs, batch records, protocols, deviations, CAPAs, and reports
• Support tech transfer with Process Development and MS&T teams to introduce new GMP processes
• Initiate, investigate, and close deviations and CAPAs; lead RCA investigations
• Troubleshoot manufacturing processes and equipment with Facilities, Engineering, Validation
• Collaborate with production leadership to develop and implement processes meeting timelines
• Recommend and support procurement of equipment and supplies to improve efficiency
• Participate in facility expansion, equipment qualification, validation, and continuous improvement
• Perform and oversee cleaning and maintenance of manufacturing equipment and controlled environments
• Collaborate with internal and external clients during campaigns, providing technical support
• Perform other duties as assigned

Skills

Upstream/bioreactor

Downstream/chromatography

Documentation skills

GMP knowledge

Education

High School diploma/GED

Associate degree in Scientific/Engineering/Biotech

Bachelor’s degree in Scientific/Engineering/Biotech

Tools

Microsoft Office

Job description

Catalent Pharma Solutions is seeking a Technician II, Central Services in Harmans, MD. The role supports manufacturing by applying broad scientific principles to operations in central services, contributing to bulk biologics production for Phase I/II and commercial GMP manufacturing.

Shift: Day 7am-7pm, 2-2-3 rotation, 100% onsite. The candidate will manage batch records, SOPs, deviations, CAPAs, and collaboration with Process Development and MS&T to implement new GMP processes, while