Manufacturing Process Engineer

Manufacturing Process Engineer
Our client, a global biologics organisation are currently recruiting for two Manufacturing Process Engineers to join their growing team on a permanent basis. As Manufacturing Process Engineer, you will provide technical expertise in Upstream/Downstream processing to support the commercial manufacturing of therapeutic proteins in a mammalian cell culture facility. Reporting into the Manufacturing Technology (MT) Lead, you will ensure manufacturing processes are validated and maintained within their validated states.The ideal candidate will have the ability to deliver tech transfer activities for new products and provide previous technical experience and process knowledge to support on-going optimisation of the upstream/downstream process.

Responsibilities

• Provide expertise for all aspects of mammalian cell culture process; vial thaw through to harvest
• Provide SME support for cell harvest technologies e.g., centrifugation, depth filtration and perfusion technologies
• Assess and monitor culture performance through Viable cell density, metabolite and nutrient monitoring relating to cell culture performance and product quality.
• SME for bioreactor control strategies, e.g.; DO, pH, feed, base CO2 etc
• Lead the analytical monitoring on processes such as protein concentration, impurity monitoring and clearance (HCP, DNA etc.) and the impact to product quality
• Provide expertise in column packing techniques and technical troubleshooting
• Apply scientific principles to support process deviations and provide product impact assessments
• Work closely with the extended manufacturing team ensuring any actions and plans are clearly understood and accounted for in alignment with plant operations plans
• Identify and lead process improvement projects and cost reduction projects and work cross functionally to prioritise projects/support demands from the Business Unit
• Author APQR and process impact assessments to support investigation closure as applicable
• Implement process CAPA’s and performance improvements, conduct investigation trending
• Author or review, and approve process validation strategies, protocols and reports
• Coaching fellow process scientist and manufacturing personnel to increase technical knowledge of critical process steps and develop plans to build competencies and expertise
• Participate in safety, process and environmental investigations. Review alert and action limits as needed and implement corrective action as appropriate
• Ensure investigations are closed on time, recurring deviations are tracked, and that true root cause and effective CAPA are identified and implemented
• Change Control write up, close out and approval as applicable
• Responsible for analysis of routine statistical process control charts and follow-up of trends flagged.
• Key technical SME participating in regulatory audits
• Introduction, design and qualification of new or alternate single use technology consumables or raw materials
• Work to implement a culture of Right-First Time through partnerships with manufacturing shift teams and provide leadership in the use of Opex principles to optimise technical and business processes
• Support the disposition process. Ensure all data is ready in a timely fashion to support business unit disposition metric

• Third level qualification in a Science or Engineering related subject is essential
• Substantial experience in Upstream and/or Downstream processing in a large-scale biopharmaceutical facility with demonstrated expertise
• GMP/Commercial manufacturing experience in a mammalian Cell culture and/or associated Downstream processing
• Interpretation of process trends e.g. bioreactor profiles, chromatograms etc
• Experience in the design and execution of process validation studies e.g. PPQ- mixing, hold, membrane and resin lifetime studies etc
• Previous experience in the generation of sampling plans
• Experience in a client facing role would be advantageous
• Knowledge of Bioreactor design and concepts
• Deep understanding of bioreactor control strategies e.g. DO, pH, feed, base CO2 etc.
• Have an awareness of cell culture characterisation and validation studies e.g. LIVCA, KLa Studies and their purpose
• Deep understanding of chromatography theories and principles
• Knowledge of purification equipment modes of operation and design
• Strong understanding of downstream segregation principles and contamination prevention, e.g. viral, microbial and cross product control
• Excellent communication skills including computer literacy and ability to work independently and in team
• Ability to communicate with all levels and functions across the site
• Excellent focus and attention to detail
• Innovative and strives for continuous improvement