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Details

Manufacturing Operations Technician


Reference:ADKY-344756 Location: Dublin
Qualification:DegreeExperience:2-3 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Biotechnician, Manufacturing Executive

Manufacturing Operations Technician
Our client a global biopharmaceutical organisation requires a Manufacturing Operations Technician to join their team on a permanent basis. The successful candidate will be directly involved in the manufacturing of products to the required safety, potency, and efficacy while ensuring quality and cGMP guidelines are adhered to also.

Responsibilities
• Responsible for execution of all tasks associated with the preparation for and production of t products in cGMP environment ensuring full attention to detail and excellent documentation skills
• Assist in maintaining a safe, cGxP compliant work environment at all times
• Responsible for completion of tasks according to SOPs and production batch records (PBR’s)
• Participate on project teams through all phases of the startup projects; these phases will include Equipment installation and start up, commissioning, validation, and qualification of equipment
• Support introduction of new products into sustaining operations through the execution of Product Demonstration and Validation activities
• Support Engineering, Calibration and utility equipment maintenance activities - Perform initial troubleshooting of issues identified during startup and routine operations.
• Provide input into the creation and maintenance of area SOPs, batch records and maintenance routines
• Assist with the training of colleagues in SOPs, process execution and equipment operation and troubleshooting
• Provide support to Quality Operations where required
• Drive a culture of Engagement and Continuous Improvement through identifying and implementing opportunities for improvement in process efficiency and compliance.
• Provide support for initiation and completion of deviations, CAPAs, and change controls for process systems
• Performs investigations relating to equipment malfunctions
• Provide technical knowledge and support the implementation of site EHSS policies

Requirements
• Previous experience in an engineering role and a working knowledge of production operations with a strong focus on attention to detail and compliance to all regulatory standards.
• An ability to work independently and as part of a team. The individual in this position will be able to organize his/her own work on a routine basis and requires minimal supervision.
• Minimum certificate level qualification in an Engineering related discipline (Chemistry, Engineering, Biotechnology etc.) plus a minimum of 3 years relevant experience in a cGMP commercial manufacturing environment.
• Prior hands-on experience of managing work using a Computer Maintenance Management System
• Experience in troubleshooting and providing technical support for cGMP manufacturing process equipment in a cGMP processing environment
• Ability to read and understand sophisticated architectural, equipment and system drawings.
• Knowledge of GMP utility systems (i.e., WFI, clean steam, pharmaceutical gas systems).
• Experience in working in cross functional teams
• Experience in working with equipment manufacturers and developing preventative maintenance procedures for cGMP manufacturing equipment
• Good interpersonal and communication skills, verbal and written
• Thorough, diligent, good attention to detail
• Collaborator with strong levels of engagement with individuals and team
• High level of delivery and work completion. A proven track record of delivering on commitments.


If you would like further Information you can contact the recruiter directly:

Sinead Cullen | Tel: +353 (0) 1 507 9252