Lead Process Sme

Lead Process SME
Essential skills- Small Molecule, Process Safety and Containment
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Lead Process SME
Position Summary
Engineering and Technology Solutions (ETS) is a global group within Global Engineering and Real Estate (GERE), offering a range of services.
The Subject Matter Expert (SME) is often called upon to support the GERE led Capital projects to ensure that they are delivered effectively with the right specified solutions, aligned to the business requirement.
These include complex and new technology that might require significant development, extensive testing and will significantly change in business.
The Lead SME is a technical leader for the delivery of GERE-led capital projects at our Biopharmaceutical sites and has a dual role.
Firstly, they set the technical direction and have overall accountability for the entire scope of work from initial concept through to successful operation.
They are the lead decision-maker, set the design principles and provide support to the individual SMEs in their technical area.
They also coordinate the planning, allocation and task management of activities across the SME team, to ensure resource availability and technical delivery across all relevant work packages.
Secondly, as an individual SME on specific packages, they provide technical direction for specification, design, supplier selection and delivery during the different stages of the capital project.
The Lead SME will advise the Project Manager (PM) and the Project Technical Manager (PTM) about the options and the recommended actions going forward that would deliver the best results, both on specific work packages and with respect to the size and shape of the SME team in their technical area.This will ensure can hold suppliers to account and challenge where appropriate.
The Lead SME provides technical assurance of a successful outcome on all work packages in their technical area and delivers resource allocation/coordination across all relevant work packages.
The Lead SME will provide technical governance to the project delivery organization throughout the project lifecycle assessing design as well as the assessment of our project Engineering partners capabilities and standards at the key stages.
As a Lead SME there is a responsibility to look for opportunities within the area of expertise to step change the business performance in existing operations and new expansions including using new technologies and digital solutions.
They keep abreast of developments in their area of expertise, assessing the use of future application within the business so that the company is well placed to develop the next generation of medicine for patients effectively.
As a Lead SME there is a need to support the current operations with technical challenges and ensure that standards across the globe are maintained.
Championing environmental sustainability as part of the design process will ensure that the company achieves its future targets.
Across the network significant Capital Projects are managed by GERE and have a wide range of complexity and follow the Capital Project Delivery Process (CPDP).
For the assigned process technology area, the SME will:
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 their 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, SET and other 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 sponsored by GERE or other senior stakeholders.
Ensure business continuity in the respective areas is maintained and areas of concern are flagged.
Identifying technical solutions that support 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 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 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.
Why Join Arcadis?
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Taking a skills-based approach, we provide opportunities for you to shape your career, maximize your impact, and grow professionally.
By joining us, you'll engage in meaningful work that drives sustainable solutions for a better planet while leaving a lasting legacy.
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