This position involves developing, reviewing, and maintaining technical documentation that supports Engineering, Manufacturing, and Inspection operations, while ensuring compliance with GMP standards.
Key Responsibilities
* Develop, review, and update Standard Operating Procedures (SOPs) and other supporting technical documentation for Engineering, Manufacturing, and Inspection.
* Manage, own and oversee change controls across functional areas.
* Collaborate with Manufacturing, Inspection, and Engineering teams to coordinate change controls and documentation updates in a timely and effective manner.
* Develop and execute protocols within Manufacturing and Inspection in support of change controls. Lead investigations, manage deviations, and coordinate troubleshooting efforts with subject matter experts (SMEs).
* Participate in projects focused on continuous process improvement and issue resolution.
* Work closely with Quality Assurance to ensure that all processes and documentation comply with current Good Manufacturing Practices (GMP).
* Support the Production Support team to minimize document turnaround times.
* Utilize approved software systems and standard procedures to compile, maintain, and track documentation, including SOPs and related records.
* Provide technical and administrative support to cross-functional teams, including document preparation, data collation, and tracking of SOPs.
* Take ownership of deviation management and ensure timely documentation and resolution.
Basic Qualifications
* Bachelor's degree (or equivalent) in a relevant discipline.
* Experience favorable in Aseptic practices, Upstream and downstream manufacturing, Engineering, Validation, and Aseptic Processing within the biotechnology or pharmaceutical sectors.
