Specialist II - MTS/MSAT
Core
Provide technical (scientific/engineering) knowledge to enable GMP manufacturing, ensure regulatory compliance, and support aseptic/non-aseptic pharmaceutical and medical device manufacturing processes.
Role type
Manufacturing Technical Specialist II (GMP Operations)
Builds
Production batch records, SOPs, and quality documentation for pharmaceutical and medical device clients
Domain
Biopharmaceuticals and Medical Devices
Required skills
GMP process knowledge, root cause analysis, technical writing, deviation management, risk assessment, material specification, clean room operations, aseptic manufacturing, regulatory guidelines (FDA QSR/ISO 13485), troubleshooting
Preferred skills
GMP scale manufacturing equipment operation, Quality Deviation Management Systems, medical device industry experience
Technologies
MS Office (Word, Excel, Access, PowerPoint, One Note)
Responsibilities
Provide technical support for process transfers with minimal supervision; author and revise production batch records and SOPs; conduct complex investigations and root cause analysis; manage CAPAs and quality documentation; train manufacturing personnel; interface with clients regarding manufacturing materials and processes; adhere to safety procedures and EHS regulations
Seniority
Mid-level, hands-on IC