Manufacturing Technical Operations Specialist III (MTO Specialist)

Position Summary

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.

Shift: Monday - Friday, 8am-5pm
Location: Harmans, MD - BWI
100% Onsite

The Role

• 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

The Candidate

 Minimum 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.

Preferred Skills & Background

• 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

Pay

The anticipated salary range for this position in MD is $120,000 – $140,000 Plus Bonus. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states.

Why You Should Join Catalent

• Defined career path and annual performance review and feedback process
• Diverse, inclusive culture
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• Competitive paid time off plus 8 paid holidays
• Community engagement and green initiatives
• Medical, dental, and vision benefits effective day one of employment
• Tuition reimbursement