Blackfield Associates
Mechanical Critical Utilities SME
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We are currently seeking an experienced Mechanical Critical Utilities Subject Matter Expert (SME) to support a major pharmaceutical capital project in the United States.
The successful candidate will provide technical leadership and governance for mechanical critical utility systems throughout the project lifecycle, from early design and specification through procurement, commissioning, qualification, and start-up.
This is a client-side technical leadership position, working closely with the project delivery organisation, design contractors, equipment suppliers, and wider engineering stakeholders to ensure that mechanical critical utility systems are designed, delivered, and commissioned to the required technical, GMP, safety, and operational standards.
The role will require three days per week on site in the Manchester area, with the remaining time potentially worked remotely. The successful candidate will also support the wider US project and may be required to engage with project teams and suppliers internationally.
Key Responsibilities
- Provide technical direction and leadership for mechanical critical utility systems throughout the project lifecycle.
- Provide early technical input into FEED and subsequent design stages as required.
- Gather and communicate relevant process, product, and technical requirements to design contractors and equipment suppliers.
- Define and translate technical, GMP, engineering, and safety requirements into clear engineering deliverables and specifications.
- Work closely with design contractors to develop and assure the design of mechanical critical utility systems.
- Carry out periodic design assurance reviews to ensure technical alignment, compliance, and identification of value engineering opportunities.
- Review and approve relevant engineering deliverables, specifications, calculations, drawings, and technical documentation.
- Ensure appropriate User Requirement Specifications (URS) are developed, technically accurate, and suitable for subsequent commissioning and qualification activities.
- Support the technical assessment and selection of critical equipment suppliers and contractors.
- Contribute to procurement strategies and the technical scope of mechanical critical utility packages.
- Ensure relevant handover and operational requirements are clearly defined and incorporated into the project.
- Provide technical guidance and coaching to project and work package teams.
- Participate in SHE and technical risk assessment activities and ensure appropriate mitigations are incorporated into the design.
- Ensure mechanical critical utility solutions meet project requirements for quality, cost, schedule, sustainability, and operational performance.
- Provide technical support throughout equipment manufacture, construction, commissioning, and qualification.
- Review and approve relevant FAT, SAT, DQ, IQ, and OQ documentation and protocols.
- Attend and contribute to pre-FATs, FATs, mechanical completion inspections, and SATs where required.
- Provide technical assurance and approval for critical packages prior to shipment, commissioning, and qualification.
- Provide technical support in resolving technical issues during detailed design, commissioning, and qualification.
- Support start-up, process qualification, and early operational activities as required.
- Provide technical input into lessons learned and continuous improvement activities.
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Operational Lifecycle Responsibility
The SME will also consider the complete operational lifecycle of the mechanical critical utility systems, including:
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- Maintenance and calibration access.
- Equipment access and maintainability.
- Cleaning requirements.
- Material and waste movement.
- People movement and operational flows.
- Ancillary rooms, equipment, and storage requirements.
- Spare parts and maintenance requirements.
- Lifecycle cost and sustainability considerations.
- Operational performance and reliability.
Requirements
- Significant experience as a Mechanical Engineer, Mechanical Utilities Engineer, Mechanical SME, or Technical Authority within pharmaceutical, biotechnology, or another highly regulated manufacturing environment.
- Strong experience with critical mechanical utility systems within major capital projects.
- Proven experience providing technical leadership and design assurance rather than solely executing design activities.
- Strong understanding of GMP/GEP requirements and their application to engineering and utility systems.
- Experience working across the project lifecycle from FEED and design through procurement, construction, commissioning, qualification, and start-up.
- Experience with equipment suppliers, technical specifications, URS development, and vendor documentation.
- Experience reviewing or approving FAT, SAT, DQ, IQ, and OQ documentation.
- Experience participating in technical risk assessments, SHE activities, and design reviews.
- Strong stakeholder management skills with the ability to work effectively with design contractors, suppliers, and project delivery teams.
- Ability to act as a technical authority and provide clear guidance and direction to engineering and project teams.
- Excellent communication and technical documentation skills.
Location & Working Arrangement
Manchester area, 3 days per week on site.
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