We are seeking a highly skilled Biopharmaceutical Operations Specialist to join our team in a scientifically innovative environment.
Key Responsibilities:
* Deliver expert-level execution of manufacturing-process unit operations according to established standard work instructions and protocols.
* Operate and maintain complex manufacturing equipment and technology within the functional area with high levels of expertise.
* Develop, author, and approve operating procedures & documentation for large-scale biopharmaceutical manufacturing processes.
* Provide training content design and oversee the competency development of Manufacturing Specialists on-the-job.
* Drive Right-First-Time execution on shift and provide front-line support/resolution of manufacturing issues and problems.
* Lead investigations in Quality Management Systems (QMS) and drive effective CAPA implementation and improvement initiatives.
* Promote Good Manufacturing Practices, Good Documentation Practices, and adherence to Standard Operating Procedures and policies.
* Manage dynamic schedules in fast-paced production environments and make adjustments as needed to meet business objectives.
Requirements:
* A minimum of Level 7 qualification in an Engineering/Science related discipline such as Chemical Engineering or Biochemistry.
* Significant experience working in large-scale biopharmaceutical manufacturing facilities with proven track records of success.
* Strong technical skills and knowledge of control and data acquisition systems including Delta V and MES.
* Automation experience including troubleshooting and running technical queries and reports in support of investigations and Data Integrity.
* Demonstrated ability to work independently and collaboratively as part of a cross-functional team to achieve demanding schedules and goals.
* Proven problem-solving abilities and proactive approach to drive process improvements and efficiency gains.