GerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services.
About Us
We partner with many of the world's largest life science & technology companies who entrust in us to deliver their most strategic and important projects with our technically strong personnel ensuring all important activities meet both current requirements and client's needs.
Project (Automation) Engineer
The Project Engineer is responsible for safely coordinating and leading projects associated with Automation, Aseptic processing, new processing equipment, packaging, new Facility builds or modifications/extensions.
The primary responsibility of the role is to ensure that the project meets its agreed goals/targets on time and on budget.
The engineer reports project progress to the Project Manager to ensure the equipment/facility design and goals/targets are achieved.
Responsibilities:
* Safely coordinate the delivery of processing equipment to the site based on planned timelines and scope.
* Processing equipment would include e.g. autoclaves, LAF units, moulds, extruders, packaging equipment, automated vision inspection systems, lyophilsers, isolators, containment booths, stopper processing equipment and equipment upgrades - both hardware and SCADA.
* Coordination of equipment installation and services hook up, working with equipment vendors and engineering personnel.
* Lead the Project Team or support the Project Manager in Factory Acceptance Testing program.
* Coordination of all equipment documentation requirements.
* Commissioning of equipment for validation activities.
* Preparation of equipment training and maintenance protocols.
* Report into the Project Manager on project progress and advice/support on key project outcomes
* Contribute in a team environment on specific technical problem solving forums associated with product manufacture, aseptic fill and Packaging.
* Deliver Process improvement projects.
* Work with the relevant Business Unit team leaders to implement improvement opportunities
* Lead regular Equipment/Facility Project review meetings.
* Attend the weekly Tier Meetings.
* Attend monthly Department Meetings
Education & Experience:
Third level qualification in an Engineering or Science or equivalent discipline/experience (Automation)
Experience of working within either the medical device or bio/pharmaceutical industry would be an advantage but not necessary.
5 years+ experience.
Project Management experience is preferable but not necessary
Essential Knowledge, Skills & Abilities:
* Experience of working on a team, including strong organizational and time management skills.
* Exposure to process/equipment projects preferred.
* Experience in a GxP regulated environment is preferred.
* Experience with manufacturing systems is preferred.
* Proficient in Windows Operating System, Microsoft Office and a good understand of PLC and Scada systems preferred.
* Flexibility to respond to production issues outside normal business hours.
* Ability to learn new and different technologies.