The head of Process Engineering and Technical Services leads a team of technical experts and SMEs at the company Development and Manufacturing Facility. This role is responsible for providing Technical Leadership and direction for the site and its products as well as providing technical support for external suppliers and manufacturing CMOs. The role will be part of the site leadership team. This role will collaborate closely with the site operations and quality team. It will also interact closely with the Process Development (PD), the Manufacturing Sciences (MS) , the New Product and Technology Introduction (NPTI) team and also other company manufacturing sites to deliver best in class technical solutions supporting product supply to patients.As a member of the Site Leadership Team, the role is critical to the future growth of the company by building upon and further developing a high performing knowledge based Technical Services team and development of management systems to support this team.
- Provide Technical leadership and direction for site and its products
- Lead and develop the technical team, providing growth opportunities and support for team members.
- Strong collaboration with onsite Laboratory Services Leader is essential to deepen technical and scientific understanding of products and processes, resolving technical issues and providing continuous improvement for processes.
- Collaborate with Process Development (PD) and Manufacturing Science (MS) technical experts across the company, ensuring consistency of technical approach and technical standards to strive for best in class performance.
- Co-lead the introduction of a technical services laboratory for site, working alongside laboratory services manager to define, layout, set up, ownership, operation and management of this new functional area on site.
- Design and implement technical studies and programs as appropriate to support investigations and product improvements.
- On site ownership of equipment, process knowledge and technology
- Provide Process Validation and CPV leadership establishing and maintaining statistical process control systems in collaboration with, Manufacturing and Quality functions.
- Oversight of planning, executing and reporting for all process related aspects of technology transfer projects. In addition, this role may be project manager for specific technology transfers.
- 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
- Establishing/confirming specifications for raw materials, process parameters, process controls and equipment.
- Sourcing and procuring process equipment including technical oversight of procurement process.
- Establish and maintain statistical process control systems in collaboration with Manufacturing and Quality functions.
- Developing knowledge of new pharmaceutical manufacturing processes as required in line with company business objectives.
- Manage the time, cost and quality of assigned projects.
- Manage the onsite IT support for critical operational systems (dotted line reporting).
- Assuming accountability for risk assessments, including hazards, for the health and safety of company employees and visitors.
- Work closely with all leaders to monitor and where necessary implement improvement initiatives in line with continuous improvement philosophy.
- Manage direct report(s) and optimise their contribution to company culture and business.
- Relevant primary degree in Engineering/Science,
- Preferred masters or PhD in engineering, chemical or process engineering preferred.
- Minimum 10 years demonstrated experience in an operational execution / technical function in pharmaceutical manufacturing.
- Specific experience in process validation to US/EU markets, with capability to transfer this knowhow in support of other global markets.
- Strong record of achievement in managing highly motivated SMEs
- Demonstrated experience of technical writing of complex issues to support regulatory submissions and inspections.
- Must have experience in taking a lead role presenting at regulatory inspections.
- Advanced level of technology experience required, broad experience across drug manufacturing technologies and dosage forms preferred.
- Demonstrated track record of training and coaching colleagues to improve overall team knowledge
- Good knowledge of quality systems both FDA and EU regulations as they relate to manufacturing, facilities and process engineering.
- Proven project management skills for technical programs including budget setting and resource allocation
- Project management professional (PMP) an advantage
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