MTO Technical Writer – Manufacturing Specialist

Job Description

The Manufacturing Technical Specialist will provide support for Manufacturing Management and Associates to meet batch record review/disposition schedule to adhere to lot release dates. The Manufacturing Technical Specialist will be responsible for, executing root cause investigations, owning/authoring deviations, driving continuous improvement efforts and other quality report types, and revising GMP documents such as SOPs and Manufacturing batch records.

The Manufacturing Technical Specialist role is critical to our patients. Manufacturing life-saving medicines right the first time with patient safety in mind is our priority. Quality, safety and on-time delivery is a must to be successful in this role!

The Role:
• Initiates Quality Records and conducts deviation investigations that meeting both Industry and Company expectations
• Leads or manage investigations including root cause analysis and assesses product impact using input from various departments
• Develops, executes and oversees CAPAs
• Technical leadership will be required to ensure that product and process understanding is sufficient to investigate deviations, that investigations are technically sound, meet quality expectations, and that corrective actions are effective.
• Supports Tech transfer and process monitoring support as needed
• Works with the team to monitor critical process parameters
• Revision and management of manufacturing documents such as Batch Records and SOPs
• Leads or supports Continuous Improvement projects
• Conducts data gathering, trending, and data presentation as needed to support investigations
• Responsible for real time, on the floor response in support of operational deviations by gathering information and completing an initial event report.

The Candidate:
• Bachelor’s degree in a science or engineering field and 4+ years of demonstrated technical competency in biopharmaceutical manufacturing processing in a GMP compliance environment (e.g. Production, Development, Process Engineering, Technical Services or related field)
• 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
• 3+ years of experience in process deviation investigations and remediation

• Ability to perform interviews and familiarity with root cause analysis
• Previous experience authoring and/or revising technical documents
• Ability to support and/or lead system troubleshooting efforts

Key leadership attributes:
• Leads with Integrity and Respect
• Delivers Results
• Demonstrates Business Acumen
• Fosters Collaboration and Teamwork
• Champions Change
• Engages and Inspires
• Coaches and Develops

Position Benefits:
• Potential for career growth within an expanding team
• Defined career path and annual performance review & feedback process
• Cross-functional exposure to other areas of within the organization
• Medical, Dental, Vision, and 401K are all offered from day one of employment
• 19 days of paid time off annually + 8 paid holidays
• Gain experience in the cutting-edge gene therapy space
• Tuition Reimbursement”