Lead Process SME

Summary:
Our client is a global biopharmaceutical company looking for a Lead SME to join their team. The incumbent can be located either in UK or Irish site. The Lead SME will drive technical leadership for capital projects and set design principles, coordinate SME teams, and ensure delivery aligns with business requirements.
They will provide technical direction on project work packages and advise PMs on optimal strategies.
The role includes assuring supplier performance, technical governance, and leveraging innovation to improve operations while upholding global standards, support ongoing operations, and champion sustainability in project design.
Responsibilities:
Establish trusted relationships with key stakeholders
Set the technical direction and have overall accountability for the entire scope of work from initial concept through to successful operation
Act as Technical Decision maker for the assigned area of scope
Demonstrate visible and proactive leadership of colleagues, design organisations and suppliers to ensure complete and complaint specification, delivery and performance of critical packages.
Review, accept and approve key technical documentation e.g. URSs, PIDs, FAT and SAT protocols
SME is the technical point of reference for their relevant area of expertise. Develop and maintain internal and external technical networks in order to stay abreast of available technical solutions from both suppliers and industry competitors. Prepare and present technical solutions and options to senior leadership including project sponsors, and business units.
Coordinate with Global Procurement to identify and select the most appropriate suppliers for critical packages
Work closely with the site receiving team. This is pivotal for success in preparing for the hand over from the technology viewpoint, ensuring the stabilisation of the introduction and capabilities are appropriate within the team to achieve a smooth transition and beneficial operation.
Ensure User Requirement Specification (URSs) are produced and are complete (GMP, GEP, and Safety, Health & Environment requirements), technically accurate and appropriate for calibration and qualification execution.
Utilizing LEAN and Change Management tools, provide strategic leadership to process improvement programmes Ensure business continuity in the respective areas is maintained and areas of concern are flagged.
Identifying technical solutions that support the company’s sustainability and environmental ambitions
Provide all relevant process products and technical information to share with design contractors and equipment suppliers so business needs can be delivered.
Execute facility technical audits both internal and external in area of specialty to establish gaps from the company and industry cGMP standards.
Support the planning and implementation of commissioning and qualification activities.
Lead process risk assessments in order to establish and deliver safe process operations and have compliance when manufacturing products to their quality standards.
Provide a leading input into process risk assessments (HAZOP, FMEA) in order to establish and deliver safe process operations and meet drug substance quality requirements.
Be accountable for the technical input into the Design Review process and ensure that the project business objectives can be achieved.
Provide construction phase technical audits and agree, approve and witness GMP equipment testing and factory acceptance testing (FAT) including authorization to release equipment from supplier to AZ site if required.
Provide technical support to facility, equipment, system in the commissioning and qualification process.
Review and approve DQs, FATs and SATs for GMP critical systems as required.
Attend relevant pre-FATs SATs to assure completeness correctness and URS alignment can be delivered
Qualifications & Experience:
Bachelor’s or Master’s degree in Engineering, Technology, or a relevant scientific discipline.
Professional Engineering Certification or Chartership (e.g., CEng, PE) – highly desirable.
Project Management qualification (e.g., PMP, PRINCE2) – an advantage.
Strong knowledge of GxP, cGMP, or regulated environments in the pharmaceutical/biotech industry.
Experience:
10+ years of technical experience in engineering, capital project delivery, or manufacturing systems within pharma, biotech, or a similar industry.
Proven track record of leading complex capital projects from concept through to operation.
Experience in specification, design, supplier management, and technical governance.
Demonstrated ability to lead cross-functional teams and manage multiple stakeholders.
Familiarity with emerging technologies, digital solutions, and sustainability practices in engineering.
Excellent problem-solving, communication, and decision-making skills.
Experience working in a global matrix organization with cross-site coordination.

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