This role is a 12 Month contract with a view to extension.
provide process engineering support to Sterile Fill Finish Drug Product, in the design, commissioning and qualification of equipment and processes to facilitate the manufacture of development, clinical and commercial existing products. This role requires good judgment and strong initiative. You need to have the ability to effectively prioritise and manage a diversified workload, often to tight deadlines.
Reports to: Lead Process Engineer
• Provide process engineering support to Sterile Fill Finish product teams and projects.
• Develop and support new manufacturing processes and technologies.
• Understand equipment operation in detail.
• Define and review equipment specifications and associated test documentation.
• Support project delivery through FAT, SAT, and IOQ involvement as needed.
• Troubleshoot equipment issues with particular emphasis on process cycles (e.g. cleaning, sterilizing).
• Identify means to improve processes, increase efficiencies and reduce costs.
• Strong focus on disciplined root cause analysis.
• Liaise with vendors on disposable technology and integration into the process.
• Development of process cleaning and sterilization cycles.
• Development of critical process parameters for the process and development of process capability and deviation monitoring.
• Monitor process risk and ensure mitigations are in place as required.
• Benchmark other industries and organizations to ensure best practice is in use.
• Be active in the network, attending conferences/training seminars as needed.
Health, Safety, and the Environment
• Comply at all times with the Health, Safety, and Environmental policy and associated procedures.
• Continuously promote a positive safety culture by challenging yourself and others to prioritize safety in everything you do.
• Ensure all work carried out, complies with the required standards, and conforms to company, cGMP, cGLP, SOP’s and regulatory guidelines.
• Take ownership of quality compliance in all activities under the responsibility of the role.
• Qualified to a minimum Degree level in engineering or related discipline.
• Minimum 8 years of Process Engineering / Technical Services experience within a relevant Pharma. environment (preferably within a sterile manufacturing environment).
Skills and Behavioral Competencies Skills
• cGMP compliance.
• Capable of developing and implementing solutions to complex problems within a team dynamic using proven problem-solving techniques.
• Ability to understand engineering processes through a logical, data-driven, hands-on approach.
• Use of FMEA, FMECA, and Risk assessment techniques.
• Can interact with audits (internal and external) providing technical assurance from a quality and safety perspective.
• Strong report writing skills.
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