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Engineering Technician

4 weeks ago

Sligo, Sligo, Ireland Orion Group Full time

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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