Job Title: Technical Operations Specialist
We are seeking a skilled and experienced Technical Operations Specialist to join our team.
This role involves supporting Visual Inspection operations in line with all safety, regulatory, and organizational requirements.
Key Responsibilities:
* To work as part of a team to support the manufacturing operation by developing and modifying procedures as needed.
* Participate in process, equipment, and facilities validations efforts and projects implementations.
* Review and approve process-related commissioning, qualification, and validation protocols for completeness and accuracy.
* Execute protocols in a timely basis to meet project schedule requirements.
* Lead Process FMEAs for Visual Inspection Establishment, Optimize the process for certification of technicians for visual inspection.
* Establish and maintain a defect library.
* Establish and execute the process for trending of Visual Inspection Defects.
* Ensure all site procedures are aligned with Global Guidance Documents and Regulatory Requirements.
* Provide technical input to guide the development of SOPs for Visual Inspection.
* Support production teams in ensuring that manufacturing processes are enabled and maintained to meet output and yield requirements.
Requirements:
* A relevant third-level qualification in an engineering, science, or technical discipline (Degree Level or Masters Preferable).
* At least three years of total combined experience in Technical/Operations/Quality or equivalent in a pharmaceutical or health care organization.
* Previous experience in manufacturing processes of biotechnological drugs, parenteral drugs, solutions preparation, fill finish, Lyophilisation, sterilization operations preferable.
* Experience in clean utilities is desirable.