Manufacturing Process Specialist

2536 - Manufacturing Process Specialist
 
Team Horizon is seeking a Manufacturing Process Specialist to support a new product into our client’s site. The Manufacturing Process Specialist will provide technical expertise and act as SME for the Manufacturing department.
The MPS is responsible for providing Technical Leadership and direction for the manufacturing department. The role will be part of the manufacturing group. This role will collaborate closely with the site operations, engineering, and quality groups. It will also interact closely with the Tech Ops and New Product Introduction (NPI) team and other company manufacturing sites to deliver best in class technical solutions supporting product supply to patients.
 
Why you should apply:

• Our client has developed a culture of innovation, inclusion, and development, and consistently features as a great place to work.


• This is an opportunity to work on a brand new facility working with state of the art equipment.

 
What you will be doing:

• You will provide Technical leadership and direction for the Manufacturing department, Subject Matter Expert (SME) in the formulation, aseptic filling process, isolator technology and representation at various regulatory audits.


• You will provide technical assistance to the manufacturing areas related to the manufacturing process and equipment.  These areas are highly dependent on technique, detailed procedures, equipment and controls. 


• The position requires dealing with difficult technical problems in a highly technical and regulated Biologics Plant. This position requires developing and implementing changes that will improve equipment performance and consequently product quality


• On site ownership of manufacturing equipment, process knowledge and technology


• Sourcing and procuring process equipment including technical oversight of procurement process.


• Provide technical support for the Manufacturing Process and Equipment


• Collaborate with technical groups and experts across the network, ensuring consistency of technical approach and technical standards to strive for best-in-class performance.


• Design and implement technical studies and programs as appropriate to support investigations and product improvements.


• Developing knowledge of new pharmaceutical manufacturing processes as required in line with company business objectives.


• Identification and project management of continuous improvement projects. Work closely with all leaders to monitor and where necessary implement improvement initiatives in line with continuous improvement philosophy.


• Continuously drive to improve processes for improved performance and cost reduction wherever possible.


• Establishing/confirming specifications for process parameters, process controls and equipment effectiveness.


• Establish and maintain statistical process control systems in collaboration with Manufacturing and Quality functions.


• Monitoring and analysis of process data during the manufacturing of drug product.


• Oversight of planning, executing, and reporting for all process related aspects of technology transfer projects.


• Support the introduction of new products and process to site, working alongside all functions.


• Lead teams on identifying root cause and corrective actions for process deviations utilising best practice problem solving and continuous improvement methodologies in collaboration with other functions.


• Assuming accountability for risk assessments, including hazards, for the health and safety of company employees and visitors.


• Develop and modify procedures as needed to support the manufacturing operation.


• Participate in process, equipment, and facilities validations efforts and projects implementations.


• Liasing with operations, quality and S&T to ensure equipment and process performance is maximized.


• Adhering to all relevant policies relating to Quality & Safety.


• Ensure successful external inspections, and Division and Corporate audits.


• Supervision of external contractors.

 
What you need to apply:

• At least three (3) years in pharmaceutical process engineering, with relevant experience of batch processing, technical transfers, scale-up, commissioning and validation in a cGMP pharmaceutical or Biologics industry


• Specific experience in process validation to US/EU markets


• Demonstrated experience of technical writing of complex issues.


• Must have experience in taking a lead role in investigations.


• High level of technology experience required, broad experience across drug manufacturing technologies and dosage forms preferred.


• Good knowledge of quality systems both FDA and EU regulations as they relate to manufacturing, facilities and process engineering.


• Experience in new product introductions is desirable


• Demonstrated project management skills, including the ability to deliver projects on schedule, within budget, and meeting the predefined quality requirements are required


• Experience working with lean methodologies is desirable.


• Previous experience in lyophilization and sterilization operations preferable