GerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services. 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. We have multiple projects that we support, and we are looking to add to our team. We are interested in talking to you if you fit the criteria outlined below: Project (Automation) Engineer Purpose: 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, lyophilisers, 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 and 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. Interpersonal skills required to operate in a multi-function project team set up. Ability to work within a team and on own initiative to articulate and deliver specific functional requirements for all aspects of the project and work with members of various disciplines and functions across the project. 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 understanding of PLC and Scada systems preferred. Flexibility to respond to production issues outside normal business hours. Ability to learn new and different technologies. We offer competitive compensation packages and opportunities for professional growth in a dynamic and innovative work environment. If you are a motivated Automation Engineer seeking an exciting challenge in the biopharmaceutical industry, we encourage you to apply. To start the process click the Continue to Application or Login/Register to apply button below. #J-18808-Ljbffr
GerTEK is an engineering consultancy company specialising in project management, talent solutions, and commissioning qualification and validation services. We partner with many of the world's largest life science & technology companies who entrust us to deliver their most strategic and important projects with our technically strong personnel ensuring all important activities meet both current requirements and client needs. We have multiple projects that we support, and we are looking to add to our team. We are interested in talking to you if you fit the criteria outlined below: Pharmaceutical Inspection Operator Responsibilities Work as a team member to support biologics operation in pharma operations in line with all safety, regulatory, and organizational requirements. Visual Inspection Technician will be assigned to the daily production operations. Document all activities in line with cGMP requirements. Perform final product visual inspection. Perform product intermediary packaging, as applicable. Perform in-process testing methods. Monitor Process Alarms. Material receipt from warehouse, verifying all pertinent documentation. Transfer final material to warehouse inventory. Ensure all manufacturing documentation is completed in a timely manner without errors, following cGMP's. Diagnose and resolve events or exceptions of VI process. Dispose of domestic, biomedical, and hazardous waste from their respective area as applicable, ensuring compliance with regulations following the procedures and policies of the plant, division, and the corporation. Keep detailed records, manual or electronic, of the operations carried out during the work shift. Participate actively in Factory Acceptance Testing, Site Acceptance Testing, and commissioning and qualification of equipment. Adhere to all relevant policies relating to Quality & Safety. Ensure successful external inspections, and Division and Corporate audits. Participate actively in the development of batch records and electronic batch records for the site. Work with Engineering, Quality, and other departments in the development and update of Standard Operating Procedures. Requirements Leaving Certificate and 1 year of experience in GMP manufacturing. 1 year plus of knowledge of GMP and regulatory requirements relating to the pharma/biologics industry. 1 year in Batch processing operations in an FDA/HPRA regulated industry is highly desirable. Essential : Requires annual visual test certification for colour blindness and 20/20 vision. A good knowledge of cGMP and regulatory requirements relating to the biologics/pharmaceutical industry is desirable. Experience in handling dangerous chemicals is highly desirable. Good IT skills are required. Previous inspection experience in a Pharma/Biologics facility is a distinct advantage for operators assigned to VI. Cognitive Skills Proven problem-solving skills under pressure. The position requires detailed evaluation of a number of viable solutions to each problem. A very high level of attention to detail and mental concentration to ensure accuracy and total compliance with procedures at all times. Results-driven, striving to meet all targets and metric standards as set by site/department and division leaders. Total commitment to Quality and maintaining a high standard of work at all times. Demonstrates the highest levels of integrity and a strong work ethic at all times. Strong communication skills, both verbal and written, are required for the execution of this role. Strong interpersonal skills are required. Understands and supports the principles of Perfect Performance. We offer competitive compensation packages and opportunities for professional growth in a dynamic and innovative work environment. If you are a motivated Inspection Operator seeking an exciting challenge in the biopharmaceutical industry, we encourage you to apply. To start the process, click the Continue to Application or Login/Register to apply button below. #J-18808-Ljbffr
