Blackfield Associates
Senior Process Engineer
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Senior Process Engineer
The Opportunity
An exciting opportunity has arisen for an experienced Senior Process Engineer to join a leading pharmaceutical manufacturing organisation and play a key role in delivering major capital investment projects.
As the subject matter expert for process engineering, you will lead the design, development and implementation of complex engineering solutions across a range of manufacturing and utility systems. You'll be responsible for driving innovation, ensuring compliance with industry regulations, and delivering projects safely, on time and within budget.
This role offers the chance to influence strategic investment decisions, evaluate emerging technologies, and work on projects valued at up to £10 million within a highly regulated GMP environment.
Key Responsibilities
- Lead all process engineering activities across assigned capital projects
- Provide technical leadership and mentorship to process and project engineers
- Develop engineering strategies, standards and best practices
- Take ownership of process equipment, utilities and facility design within capital projects
- Conduct design reviews with engineering partners and equipment suppliers
- Ensure engineering solutions comply with GMP requirements and relevant industry standards including ISPE, ASME BPE, ISO and Annex 1.
- Lead process safety activities including HAZOP and HAZID studies
- Develop project scopes, schedules, budgets and execution plans
- Manage project work packages from concept through to commissioning and handover
- Work closely with Operations, Quality, Maintenance, EHS and external vendors to ensure successful project delivery
- Support CAPEX governance processes, business case development and project reporting
- Identify opportunities for innovation, operational improvement and efficiency gains
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About you
To be successful in this role, you will have:
- A degree in Chemical Engineering, Process Engineering or a related discipline
- At least 5 years' experience within a pharmaceutical, biotechnology or life sciences environment
- Proven experience as a Lead or Responsible Process Engineer on capital projects
- Strong knowledge of pharmaceutical process engineering principles and best practice
- Experience delivering engineering projects within GMP-regulated facilities
- Strong understanding of process safety, risk management and engineering compliance requirements
- Excellent stakeholder management and communication skills
- Experience managing vendors, contractors and engineering service providers
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Desirable Experience
Experience with the design, installation, commissioning and qualification of:
- Water for Injection (WFI) systems
- Pure Steam systems
- Process gases and utilities
- Isolators
- Filling lines
- Lyophilisation equipment
- Autoclaves
- Parts washers
Additional desirable experience includes:
- Sterile manufacturing facilities
- Knowledge of FDA, MHRA and EU GMP Annex 1 requirements
- Understanding of ASME BPE, ISPE, ISO and British standards
- Chartered Engineer status or progress towards chartership
- Membership of a recognised professional body such as IChemE, IMechE or ISPE
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