Formulation Engineer

DP Formulation Engineer

Report to the DP Engineering Lead. As the DP Engineer within Drug Product, to ensure compliance with industry standards, and oversee engineering policies and procedures. Your role involves managing various aspects of equipment installation, validation, and maintenance to ensure the safe and effective operation of the manufacturing facility and provide technical and compliance review and/or authorship of testing protocols, reports and applicable manufacturing SOPs.

Organization Description
My client is a premier provider of vaccine services (from discovery to commercialization) with global customers in the biopharmaceutical and healthcare industries. They´re one of the world's top three contract development and manufacturing companies for biopharmaceuticals, who provide their clients with a world-leading open access technology platform. We enable our clients to research, develop and manufacture drugs from the concept phase to commercial manufacturing.

Our mission is to accelerate and transform discovery, development, and manufacturing in the rapidly growing field of biologics to benefit patients worldwide. They have a global presence and currently employ over 10,000 people and provide services to more than 200 customers worldwide, including 13 of the top 20 biopharmaceutical companies.

Your Responsibilities
In this role, you will be responsible for:

• Provide technical leadership within a new Vaccine Drug Product Manufacturing facility.
• Ensure all equipment installed is safe, effective and in compliance with industry standards.
• Ensure all company and site engineering policies and procedures are adhered to.
• Provide technical and compliance review and/or authorship of testing protocols, reports and applicable manufacturing SOPs.
• Lead Commissioning & Qualification activities for new equipment.
• Generate and execute documentation for cGMP activities including risk assessments and CQV protocols/reports.
• Management of Equipment Vendors including execution of SAT, on-site maintenance visits, management of continuous improvement projects & spare parts criticality assessments.
• Support/lead maintenance of the validated state of the equipment through execution of revalidation protocols as per Site VMP.
• Lead and participate in cross-functional teams to troubleshoot and resolve technical issues, drive continuous improvement, and process optimization using tools such as DMAIC and FMEA.
• Manage changes to equipment/process as per site change control procedures.
• Support establishment of new Preventative Maintenance Program for equipment in Drug Product suite.
• Lead/participate in equipment related manufacturing investigations with cross-functional teams to ensure that detailed root cause analysis & impact analysis is completed and appropriate CAPAs are implemented.
• Identify process and equipment improvements and develop these into CI projects.
• Support disposition of batches by addressing any potential technical / engineering related issues which may have occurred mid-batch.
• Lead/participate in TPM, CI & Gemba programs and daily / weekly tiered manufacturing meetings.
• Participate in process, design & technical reviews with external clients.
• Provide technical expertise during regulatory inspections e.g., FDA, HPRA inspections to defend systems, change controls, investigations and qualification packages.
• Support transition from project to sustaining manufacturing and ramp up of production volumes in future by improving equipment reliability through CI and TPM processes.

• Bachelor of Engineering or Science Degree in Engineering or Technology related discipline.

• Minimum 5 years cGMP industrial / engineering experience.
• Specific experience with Autoclave, Parts Washers, and CIP/SIP equipment.
• Knowledge of Formulation processes.
• Experience in executing on the floor activities such as FAT, SAT, IQ/OQ.
• Experience in data driven approach to root cause analysis and prioritization of continuous improvement initiatives e.g. Six Sigma.
• Experience in leading & resolving complex technical investigations.
• Experience in a risk-based approach to manufacturing through use of tools such as FMEA.
• Experience in start-up facilities is advantageous.
• CQV experience is advantageous.
• Knowledge of industry/ regulatory requirements such as Annex 1 desirable.