Life Science Recruitment are recruiting two Process Engineers to join the team with our Biopharmaceutical client based in Waterford.


The purpose of this position is to be the subject matter expert in our Sterile Fill Finish maintenance operation and be a recognised expert in this industry. S/he needs to also ensure equipment is maintained in a validated state meeting cGMP requirements. Development, deployment and improvement of validation processes is key to ensure the maximum levels of performance and compliance are maintained.




Role & Responsibilities:


Engineering

• Will be equipment SME for sterile operations with an indepth understanding of equipment functionality and process requirements.

• Understanding equipment operation in detail.
• Defining and reviewing equipment specification and associated test documentation.
• Support project delivery through FAT, SAT and IOQ involvement as needed.
• Troubleshooting equipment with particular emphasis on process cycles (e.g cleaning, sterilizing).
• Strong focus on disciplined root cause analysis.

• Liaising with vendors on pre-sterilized components. Defining specifications and test requirements.
• Liaising with vendors on disposable technology and integration into the process. Defining specification and test requirements.
• Development of process cleaning and sterilization cycles.
• Development of procedures and controls for High Containment applications.
• Development of Leachable and extractable reports and studies as applicable.
• Development of critical process parameters for the process and development of process capability and deviation monitoring.
• Monitoring process risk and ensuring mitigations are in place as required. Implementation of data monitoring systems to ensure process control.

• 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, is in compliance with the required standards, conforming to company, cGMP, cGLP, SOP’s and regulatory guidelines.
• Take ownership for quality compliance in all activities you are responsible for.

• Qualified to a minimum of higher degree level in engineering or related discipline
• Minimum 5 year’s engineering experience within a relevant Pharma. environment (preferably within a sterile manufacturing environment)

• 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.
• Knowledge of sterile and isolator technologies (including disposable technologies). Have an expertise in Fill Finish critical process parameters and product quality attributes.
• Experience in Cycle development and validation for sterile manufacturing.
• Use of FMEA, FMECA and Risk assessment techniques.
• Familiar with statistical process control methods.
• Operate SCADA systems and retrieve / interpret data.
• Can interact with audits (internal and external) providing technical assurance from a quality and safety perspective.
• Proven track record of building relations with equipment vendors.
• Strong report writing skills.