Orion Group Life Sciences are currently recruiting an Engineering Technician on behalf of our Multinational Biopharmaceutical Client based in Sligo on a 12-Month contract with potential to extend.
Responsibilities:
* To work as a team member to support engineering in pharma operations in line with all safety, regulatory and organizational requirements.
* Participating in design and process project conversations to ensure reliability by design is built in prior to equipment arrival.
* Owning and preparing, preventative and predictive maintenance for new pharma equipment being installed and approval of these procedures on Maximo.
* Completion and documentation of PM’s and pDM’s on manufacturing equipment into Maximo.
* Owning and ensuring that commissioning spare parts are received and cataloged in Maximo.
* Owning and ensuring that critical spare parts are identified and once received, cataloged in Maximo.
* Active Participation in Factory Acceptance Testing, Site Acceptance Testing and commissioning and qualification of equipment.
* Review and approve process-related commissioning, qualification and validation protocols for completeness and accuracy. Execute protocols in a timely basis to meet the project schedule requirements.
* Review and approve process flow diagrams (PFDs), specifications, layouts and P&IDs.
* Ensuring proactive high performance of day-to-day preventative and demand maintenance activity to maintain manufacturing and utility equipment.
* Liaising with operations, quality and technical operations to ensure equipment and process performance is maximized.
* To maintain records and documentation on relevant Engineering Procedures and preventative/demand maintenance.
* To liaise with Internal/External Engineering Personnel and contract maintenance providers in maintaining, troubleshooting, and installing/commissioning equipment.
* Completion of instrument calibration as per schedule.
* Take ownership of the site’s Predictive Maintenance program, through managing and developing the outsourced condition monitoring contracts, implementing recommendations, and tracking to closure.
* Implementation of equipment/process upgrades in an environment of continuous improvement.
* Support the Production Team in ensuring that manufacturing equipment is maintained to meet the output and yield requirements.
* Adhering to all relevant policies relating to Quality & Safety.
* Ensure successful external inspections, and Division and Corporate audits.
* Supervision of external contractors.
Requirements:
* Relevant Trade Qualification or engineering qualification to Cert level at a minimum (Diploma/Degree Preferred).
Technical/Business Knowledge:
* Minimum of 3 years in a highly regulated manufacturing (Pharma/Biologics/Medical Device) environment required.
* Proven problem-solving ability on complex equipment.
* Proven instrumentation/PLC troubleshooting ability.
Cognitive Skills:
* Requires proven problem-solving skills under pressure. The position requires detailed evaluation of a number of viable solutions to each problem.
* Requires innovative thinking, where new and untested solutions are proposed, demonstrated and implemented on a regular basis.
* Requires a very high level of attention to detail and mental concentration, to ensure accuracy and total compliance with procedures at all times.
* Must be results-driven, striving to meet all targets and metric standards as set by site/department and division leaders.
* Requires 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.
Ownership/Accountability:
* Every employee has a personal responsibility to commit to the organization's vision, to engage and align with strategic imperatives, and to consistently execute in accordance with operational goals and core ways of working.
* This role is accountable for supporting a positive developmental culture within the organization while ensuring compliance with Quality policies.
* Requires good knowledge of company policies and procedures and involves working toward general results to achieve organizational needs.
* The position has a high level of autonomy, and individuals are expected to work on their own initiative.
* Demonstrates an ethos of Right First Time at all times.
* Adheres to and follows all procedures, policies and guidelines ensuring compliance with cGMP and ISO/FDA regulations and company policies.
* Shows a high level of tenacity to ensure closure of issues.
Influence/Leadership:
* May be required to support cross-functional teams and cost improvement projects.
* Provide technical leadership to functional areas and collaborate with key stakeholders.
* Contributes to the successful delivery of site CJR’s and goals.
* Leads the delivery of new training initiatives.
Decision Making/Impact:
* Work is performed without appreciable direction. Exercises considerable latitude in determining technical objectives of assignments.
* Expected to handle all day-to-day training, learning & development queries; major problems may be referred to the Team Manager.
* Responsible for the presentation of technical data to stakeholders to ensure prompt decisions on related issues.
Supervision Received:
* Operates in an environment which is largely self-managed but with supervision.
Supervision Provided:
* No direct reports.
* Has external contact with outside contractors/service engineers and commissioning engineers, safety inspectors, equipment engineers, etc.
* May provide cross-training and guidance to new department members.
* May supervise and lead projects and develop training.
EHS Responsibilities:
* Comply with the EHS policy and procedures and demonstrate EHS best practices in all work activities.
* Continually be conscious of your own safety and that of others, always complying with safety notices and barriers.
* Report any EHS incidents and/or Near Misses (unsafe acts and conditions) immediately to your supervisor and always raise the event in the EHS system.
* Support a culture of EHS excellence by recognizing and submitting opportunities for EHS improvement in the EHS system.
* Attend all required EHS training and medical surveillance programs.
* Wear PPE as required.
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