Description
Senior Process Engineer required for a novel API project in the Home Counties.Our client, a world leading pharmaceutical company is currently engaged in a £multimillion CAPEX project in the South East of England.
A major part of this investment is the introduction of a ‘novel’ API manufacturing facility.
They require a Senior Process Engineer to deliver concept studies, concept designs, write URS documentation and lead an internal and subcontracted Engineering team.
This is a fantastic long term Opportunity for a Process Engineer with significant Design experience, preferably within API (Active Pharmaceutical Ingredient) manufacturing environment.
Great Opportunity for initial 6 month contract with scope for further extension
Position Summary:
The Process Engineer, reporting to the Project Manager takes responsibility and ownership for all activities associated with their assigned Product steps. The ultimate goal is to provide Technical Support to allow the IPT (Integrated Process Team) to meet agreed operational targets for safety, quality and customer delivery performance.
Duties & Responsibilities:
• Ensures manufacturing operations are continually supported and maintained in compliance with all quality, safety and environmental regulations.
• Ensure campaign preparations are achieved to facilitate on-time campaign start-up and adherence of agreed production rate
• The preparation and routine review of Batch Records, Cleaning Procedures, Equipment Operating Procedures, Standard Operating Procedures, Protocols and Summary Reports.
• Deviation investigation / CAPA follow-up
• Drive continuous improvement program (Right first time) for relevant product and business processes.
• Application of Six Sigma and Lean methodologies when undertaking projects
• Lead projects to support compliance improvement initiatives
• Project Management of all projects associated with assigned product.
• Leads individual and/or team projects involving evaluation, implementation, training of plant personnel and troubleshooting
• Equipment and Process assessment
• Collecting and analysing process information.
• Drive Plant process validation projects
• Preparation of change control packages (incl. those for International and US Markets).
• Substitutes for IPT Technical Lead as required
Candidate requirements:
• Degree in Chemical Engineering would also consider Science degree qualified candidates.
• Ideally 3 - 4 years’ experience working in a similar role.
• Experience of working in a highly regulated manufacturing environment preferably in the API manufacturing industry, will also consider Bio-pharma/finishing plant background.
• Good knowledge of documentation requirements in a batch processing environment.
• Experience of working with plant shop floor personnel.
• Must be capable of working on own initiative, without close supervision
• Must have excellent interpersonal, communication and negotiating skills
• Demonstrate ability to work well in a fast paced dynamic team environment
• Good priority setting skills, and the ability to deal with multiple tasks
• Training ability and/or Presentation skills (Desirable)