Manufacturing Technical Operations Specialist III (MTO Specialist)

Catalent • Harmans, MD

7d • Onsite

About The Position

We have an opportunity for a MTO Specialist, III to join our team and support manufacturing operations. In this role, you will help ensure batch record review and disposition schedules are met to adhere to lot release dates. You will lead root cause investigations, manage deviations, drive continuous improvement, and revise GMP documents such as SOPs and manufacturing batch records. This position offers the chance to work closely with cross-functional teams and contribute to high-quality biopharmaceutical manufacturing.

Requirements

• Master’s degree in a scientific, engineering, or biotech field with 6 years of experience in biopharmaceutical manufacturing processing in a Good Manufacturing Practice (GMP) compliance environment (e.g., production, development, process engineering, technical services or related field) OR Bachelor’s degree in a scientific, engineering, or biotech field with 8 years of experience in biopharmaceutical manufacturing processing in a GMP compliance environment OR Associate degree or high school diploma with 8-10 years of experience in biopharmaceutical manufacturing processing in a GMP compliance environment
• Strong knowledge of GMP regulations, FDA requirements, quality systems, and controlled documentation practices.
• Experience leading deviation investigations, root cause analysis, remediation activities, and system troubleshooting efforts, including major and critical deviations.
• Proven ability to author, revise, and maintain technical documentation with strong technical writing and communication skills.
• Demonstrated success working cross-functionally, leading teams, and executing projects on time and within budget while communicating effectively with both technical and non-technical stakeholders.
• Strong analytical, problem-solving, and organizational skills, including familiarity with Lean Six Sigma methodologies, creative thinking, and the ability to manage multiple priorities.
• Collaborative team player committed to continuous professional development, with the ability to work on-site in a manufacturing/aseptic environment, including extended standing, walking, sterile gowning, and cleanroom operations.

Nice To Haves

• Previous experience operating equipment such as incubators, single-use bioreactors, depth filtration skids, tangential flow filtration (TFF) skids, chromatography skids, single-use mixers, and in-process testing equipment

Responsibilities

• Initiate quality records and conduct deviation investigations that meet industry and Catalent expectations
• Lead or manage investigations including root cause analysis and assess product impact using input from various departments
• Develop, execute, and oversee Corrective and Preventive Actions (CAPAs)
• Provide technical leadership to ensure investigations are technically sound and corrective actions are effective
• Support technology transfer and process monitoring as needed
• Work with the team to monitor critical process parameters
• Revise and manage manufacturing documents such as batch records and Standard Operating Procedures (SOPs)
• Lead or support continuous improvement projects
• Conduct data gathering, trending, and data presentation to support investigations
• Provide real-time, on-the-floor response for operational deviations by gathering information and completing initial event reports
• Actively participate in training activities and manage individual training plans
• Perform other duties as assigned

Benefits

• Medical, dental, and vision benefits effective day one of employment
• Tuition reimbursement
• Competitive paid time off plus 8 paid holidays

What This Job Offers

• Job Type: Full-time
• Career Level: Senior