Senior Engineering Manager | Collins McNicholas

Senior Engineering Manager

  • Reference: GY45446
  • Job Type: Permanent
  • Location: Mayo
  • Category: Science, Pharmaceutical & Food

Reporting to the Director of Engineering the Senior Manager Aseptic Processing will be responsible for providing technical support for the design and selection of equipment/technologies/systems used to manufacture aseptic products for commercial distribution and clinical trials.

The ideal candidate will be a subject matter expert in sterile aseptic process engineering and will provide technical assistance and troubleshooting of validated processes, to develop and support engineering design risk assessment and control strategy for new and existing systems, conduct process investigations, coordinate transfer of new process and technologies, conduct reviews of legacy processes; writing appropriate documentation supporting validation and new product transfer activities. In addition, the candidate will have extensive knowledge of sterile engineering standards and will assist in developing standards and training for personnel.

Responsibilities:

• Provide oversight and establish effective systems for the management of the aseptic engineering programme at the site
• Design, develop and implementation of a robust engineering design control strategy and roadmap for aseptic processes at the facility for new and existing equipment
• Coordinate and conduct aseptic engineering risk assessments and execute improvement plans for new and existing systems. Participate in equipment design reviews and FAT’s where relevant to ensure compliance with aseptic processing standards. Steer and/or participate in cross-functional investigations on problems/deviations including defining corrective and preventative actions
• Identify, analyse and prioritise technical or business related process improvement opportunities or problems
• Ensures manufacturing operations are continually supported and maintained in compliance with quality, safety and environmental regulations
• Project management of assigned initiatives and capital projects in accordance with the facility strategic plan
• Establish a centre of excellence program around aseptic/sterile engineering at the facility
• To develop leading aseptic engineering standards in conjunction with internal/external stakeholders
• Develop training material and standards on aseptic engineering requirements and provide the necessary coaching and training to personnel along with the upskilling of existing personnel

•Attend meetings as required

•Participate in FAT’s, SAT’s and design reviews

Skills, Experience and Qualifications:

• Third level degree in engineering, engineering science or technology with an appropriate postgraduate qualification of preference
• 10 to 15 years working in a regulated environment. Broad and in-depth knowledge of sterile pharmaceutical manufacturing environment
• Familiar with sterile filling technologies, sterilization processes, automated filling operations, RABS/Isolators, process simulation, barrier systems, compounding, lyophilisation, vial processing and cleaning processes.
• Knowledge of all relevant standards and guidance documents pertaining to aseptic process engineering

• Excellent communicator, including strong organizational and time management skills

• A track record in project management and project delivery
• A proven track record of delivering complex projects in a pharmaceuticals or biopharmaceutical manufacturing operation
• Flexibility with respect to work assignments and dealing with projects/issues outside normal business hours
• Ability to work with, coach, lead and develop cross-functional teams
• Experience interacting with and presenting to regulatory bodies such as FDA and HPRA

For a confidential discussion and more information on the role/company please email your CV to: amy.oneill@collinsmcnicholas.ie


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Amy O’Neill

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  • Amy O’Neill
  • Recruitment Consultant
  • 091706718
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