Process SME (Clean Utillities)

Summary : Our client is a biopharmaceutical company based in Dublin looking for a Process SME to lead the design of process, technology, associated inputs and associated ancillary processes for clean utilities for the project Basis of Design and detailed design. Responsibilities : Take technical ownership for all aspects of the design that impacts on the operation of the facility and collaborate with all disciplines to ensure requirements are understood and delivered. Ensure manufacturing network alignment for process assumptions, including but not limited to mass balances, manufacturing processes and technology, and process / facility control alignment. Review and approve facility controls / design elements that may impact process development or control strategy within relevant scope Provide technical direction and leadership within the technology area. Engage with key stakeholders to ensure that their needs are understood and reflected in the design. Prepare Project Technical Requirements Specification for all systems specifying performance requirements & applicable to the Companys Standards Ensure all relevant company specifications are provided to the Design Contractor. Define & agree with Design Contractor necessary design deliverables for all design stages (CD, BD, etc.) - Design Deliverables List made Project Specific including the level of review appropriate to these documents. Review Contractor response to the Project Technical Requirements to ensure the companys requirements are correctly included. Attend Project meetings on an as required basis. Ensure User Requirement Specification (URSs) are produced and are complete (CTQs, GMP, GEP and SHE requirements), technically correct and appropriate for C&Q execution. Participate in and make recommendations for the procurement strategy for technical work packages including pre-qualification / contractor selection and technical content / scope of contracts. Produce regular Design Assurance Reports?according to the plan set up by the PTM,?to ensure ongoing technical alignment. Identify value engineering opportunities. Ensure key SHE and GMP compliance requirements are reflected in the design deliverables.? Attend and contribute to SHE?risk?assessment activities to ensure alignment with the companys SHE requirements and ensure appropriate mitigations are included in the design. Provide technical guidance to Work Package Owner teams within their areas of responsibility. Ensure specific technical solutions are consistent with Customer, cost and schedule requirements. Provide input to Project Planning. Review / involvement with mechanical packages. Support development of redundancy strategy and maintenance philosophy. Review & input to Sustainability Checklist. Respond to Construction queries where the Design Contractor is unable to provide answers. Answer Design Contractor queries as required. Review Design Contractor enquiry specifications for specific items (define which) and involvement in the bid review / selection for these systems. Review a sample of documentation (drawings & calculations) for each area to ensure correct interpretation of AZ Requirements. Qualifications & Experience : Degree in Chemical or Process Engineering. 15+ years in a design role within the pharmaceutical sector Bulk Drug Substance Experience is required Biologics experience is a distinct advantage. Ability to create and maintain effective working relationships and willing to challenge behaviours and actions. Demonstrated practitioner of practical problem-solving. Detail focused completer / finisher with a results-orientated mindset. Strong leadership qualities with motivational ability to direct others in a dynamic and complex environment through change. High profession standards, holding themselves and other in the team to deliver high quality outcomes to committed deadlines.