Job Description
A chance to join a team at the forefront of new products and improvements in a Global Leading Company and play a key role in advancing manufacturing operations. As a Manufacturing Process Specialist, you will provide essential technical leadership and support for the manufacturing processes.
You will be responsible for overseeing room and equipment qualification, creating SOPs for new manufacturing processes, collaborating with vendors for equipment procurement, and establishing critical processes. This is an exciting opportunity to contribute to the development and optimization of new manufacturing capabilities.
Responsibilities:
- Act as a Subject Matter Expert (SME) in formulation, aseptic filling processes, and isolator technology.
- Represent the team in regulatory audits.
- Take ownership of manufacturing equipment, process knowledge, and technology.
- Source and procure process equipment while providing technical oversight.
- Provide technical support for manufacturing processes and equipment.
- Collaborate with technical experts across the network to ensure consistency and best practices.
- Design and implement technical studies and programs to support investigations and product improvements.
- Develop expertise in new pharmaceutical manufacturing processes.
- Identify and manage continuous improvement projects.
- Drive process improvements to enhance performance and reduce costs.
- Establish specifications for process parameters, controls, and equipment effectiveness.
- Implement statistical process control systems.
- Monitor and analyze process data during drug product manufacturing.
- Oversee planning, execution, and reporting for technology transfer projects.
- Support the introduction of new products and processes.
- Lead root cause analysis and corrective actions for process deviations.
- Develop and modify procedures to support manufacturing operations.
- Participate in process, equipment, and facilities validation efforts.
- Liaise with operations, quality, and technical teams to optimize equipment and process performance.
- Adhere to relevant quality and safety policies.
- Ensure successful external inspections and audits.
- Supervise external contractors.
Qualifications:
- Minimum Level 8 qualification in an engineering, science, or technical discipline.
- At least three (3) years of experience in pharmaceutical process engineering, including batch processing, technical transfers, scale-up, commissioning, and validation in a cGMP pharmaceutical or biologics environment.
- Specific experience in process validation for US/EU markets.
- Strong record of achievement and technical writing skills, especially for complex issues.
- Experience leading investigations and problem-solving.
- High level of technology experience.
- Good knowledge of quality systems, including FDA and EU regulations related to manufacturing, facilities, and process engineering.
- Experience in new product introductions is desirable.
- Demonstrated project management skills, with a proven ability to deliver projects on time, within budget, and to predefined quality standards.
- Experience with lean methodologies is a plus.
- Prior experience with lyophilization and sterilization operations is preferred.
