Senior GMP Manufacturing Operations Specialist (Onsite)

Catalent; Harmans (MD); On-site; USD 120,000 - 140,000; Full time

Benefits offered by this job

Medical benefits from day one

Tuition reimbursement

Paid time off

8 paid holidays

Job summary

Catalent is seeking an MTO Specialist, III to support Gene Therapies manufacturing at the Harmans, MD site. You will drive batch record review, manage deviations, and lead root cause investigations to ensure on-time lot release.

You will collaborate with cross-functional teams, revise GMP documents, and contribute to continuous improvement in a fast-paced aseptic environment on-site from 8am–5pm.

Qualifications

• Advanced knowledge of GMP regulations and FDA requirements.
• Experience leading deviation investigations and root-cause analysis.
• Proven ability to author and maintain technical documentation.
• Able to manage multiple priorities and lead cross-functional projects.

Responsibilities

• Initiate quality records and deviations investigations.
• Lead investigations including root cause analysis and assess product impact.
• Develop, execute, and oversee CAPAs.
• Provide technical leadership to ensure investigations are sound.
• Support technology transfer and process monitoring as needed.
• Revise batch records and SOPs; manage manufacturing documents.
• Lead continuous improvement projects and data analysis for investigations.
• Provide on-the-floor response for operational deviations and training.
• Perform additional duties as assigned.

Skills

GMP regulations

FDA requirements

Quality systems

Controlled documentation

Deviation investigations

Root cause analysis

CAPAs

Lean Six Sigma

Cross-functional collaboration

Analytical thinking

Education

Master’s degree in science/engineering/biotech

Bachelor’s degree in science/engineering/biotech

Associate degree or high school diploma (with 8–10 years GMP experience)

Job description

Catalent is seeking an MTO Specialist, III to support Gene Therapies manufacturing at the Harmans, MD site. You will drive batch record review, manage deviations, and lead root cause investigations to ensure on-time lot release.

You will collaborate with cross-functional teams, revise GMP documents, and contribute to continuous improvement in a fast-paced aseptic environment on-site from 8am–5pm.