Specialist II, Manufacturing Technical Operations

$93,280 - $128,260/Yr

Disability Solutions - Severn, MD

Full-time - Mid Level

Severn, MD

Administrative and Support Services

About the position

The Specialist II, MTO position at Catalent involves providing critical support to Manufacturing Associates in a state-of-the-art CGMP manufacturing facility for Gene Therapies. The role focuses on ensuring compliance with batch record review and disposition schedules, executing root cause investigations, authoring deviations, and driving continuous improvement efforts. The Specialist will also be responsible for revising GMP documents and supporting technical transfers and process monitoring, all while adhering to a Patient First culture.

Responsibilities

• Initiates Quality Records and conducts deviation investigations that meet both Industry and Catalent expectations.
• Leads or manages investigations including root cause analysis and assesses product impact using input from various departments.
• Develops, executes, and oversees CAPAs.
• Provides technical leadership to ensure investigations are technically sound and meet quality expectations.
• Supports tech transfer and process monitoring as needed.
• Monitors critical process parameters and manages manufacturing documents such as Batch Records and SOPs.
• Leads or supports Continuous Improvement projects.
• Conducts data gathering, trending, and data presentation to support investigations.
• Provides real-time, on-the-floor response in support of operational deviations by gathering information and completing an initial event report.
• Actively participates in training activities and manages individual training plans.

Requirements

• Masters' degree in a Scientific, Engineering or Biotech field with 4 years' experience in biopharmaceutical manufacturing processing in a GMP compliance environment.
• OR Bachelor's degree in a Scientific, Engineering or Biotech field with 5 years' experience in biopharmaceutical manufacturing processing in a GMP compliance environment.
• OR Associate Degree or HS Diploma with 6-8 years' experience in biopharmaceutical manufacturing processing in a GMP compliance environment.
• Knowledge of GMP's, FDA regulations and documentation procedures required.
• Experience in quality systems regulations.
• Previous experience operating equipment such as incubators, single-use bioreactors, depth filtration skids, TFF skids, chromatography skids, single-use mixers and in-process testing equipment is a plus.
• Previous experience in process deviation investigations and remediation, including major and/or critical deviations.
• Previous experience authoring and/or revising technical documents.
• Demonstrated ability to work effectively cross-functionally, lead teams and implement project plans on time and on budget.
• Excellent communication and technical writing skills.
• Ability to support and/or lead system troubleshooting efforts.
• Familiar with Lean Six Sigma Methodologies and proven analytical/problem-solving capabilities.
• Creative thinking with the ability to multi-task.
• Commitment to ongoing professional development.
• Team player who thrives in collaborative environments.

Nice-to-haves

• Familiarity with Lean Six Sigma methodologies.
• Experience in a fast-paced manufacturing environment.

Benefits

• Defined career path and annual performance review and feedback process.
• Diverse, inclusive culture.
• Potential for career growth on an expanding team.
• 152 hours of paid time off annually + 8 paid holidays.
• Competitive salary with yearly bonus potential.
• Community engagement and green initiatives.
• Generous 401K match and Paid Time Off accrual.
• Medical, dental and vision benefits effective day one of employment.
• Tuition Reimbursement.