Senior Process Engineer

at  Team Horizon

SENIOR PROCESS ENGINEER

Team Horizon is seeking a Senior Process Engineer for a leading engineering company with projects based in Cork. 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.

• Leading and managing the Process Design for Small Molecule API projects for the introduction of new products, equipment, and processes to meet all safety, quality, regulatory and operational requirements.
• Also includes leading the process design on non-production projects, such as utilities, tanks farms, incinerators and waste water treatment plants.
• 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 using the client’s trackwise system.
• 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 ensure that all new equipment is bought in accordance with appropriate site procedures & regulations.
• 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.
• Update existing Hazardous Area reports for Equipment/Process.
• 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 participate in all training and assessment activities related to the role.
• To perform all activities in accordance with current Good Manufacturing Practice.
• 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.
• And any other duties as assigned.