With 50 years of experience as innovators in biopharma facilities, our more than 3,800 skilled architectural, engineering and construction professionals continue to work with our clients to drive innovations in the industry. We provide a single-source of responsibility for all services, from strategy and concept through site selection and evaluation, regulatory compliance, design, constructability, construction management, commissioning, validation and startup. We also provide operations support and asset management services, including plant engineering, maintenance optimization and traditional maintenance and turnaround services.
The successful candidate must have strong leadership and planning qualities, be adaptable to change and be comfortable working cross functional design and production teams delivering to strict deadlines and budgets. Pharmaceutical process knowledge, equipment specification development and understanding of validation is required.
Key tasks and responsibilities:
- Participating in the Process Design for Life Science projects for the introduction of new products, equipment, and processes to meet all safety, quality, regulatory and operational requirements.
- Supporting Process development (as part of technical transfer), troubleshooting and optimisation.
- Development of process estimates, including equipment costs.
- Working with a cross functional Design team to ensure accurate completion of Detailed Design, on time and on budget
- Working with a cross functional team as part of project planning and deployment; including collaboration with supporting departments such as Technical Development, Production/Operations, Quality, Safety, Facilities and Engineering. Process mapping, gap analysis/identification for new and existing pharmaceutical manufacturing processes.
- Equipment specification, process design, commissioning (if required) and as building
- Development and Management of the Change Control for the Project
Other functional responsibilities:
- Co-ordinating design changes using the Client approved change control procedure to ensure that cGMP is adhered to.
- Generation, review and approval of project documentation (Scope, User Requirement Specifications etc)
- Supervision of Junior Process Engineers if specific project requires additional support
- Support validation activities for project activities including review of validation documentation and attendance at validation activities as required (FAT, IQ, OQ etc).
- To provide technical support to system end users of new and existing equipment including but not limited to troubleshooting technical issues and assisting with process investigations.
- To facilitate and participate in meetings and workshops as part of Projects and Continuous Improvement activities.
- Hazop attendance and management of the closeout of the Hazop Recommendations
- Provide technical updates to Standard Operating Procedures (SOPs) related to the equipment/process changes
- To adhere fully to all safety policies, procedures and regulations.
- To record and report any Process changes relating to the projects, which could impact budget and schedule
- To create, review and approve Site Engineering Specifications and other documents as required, ensuring the acceptability of content and format.
