Engineering Technician (Shift)

Orion Group Life Sciences are currently recruiting Biologics Engineering Technician (Shift) on behalf of our Multinational Biopharmaceutical client based in Sligo on an initial 12-month contract with huge potential to extend.

This role has 20% shift (days/evenings rotating on a weekly basis)
Days: 07:00 – 15:30 Monday to Thursday, 14:30 finish Friday
Evenings: 15:00 – 23:30 Monday to Thursday; 14:00 – 21:20 on Friday
Training will be standard days (2-4 weeks approx.)

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 in to 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&ID’s. Ensuring proactive high performance of day to day preventative and demand maintenance activity to maintain manufacturing and utility equipment.
• Liasing 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 upgrade 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)
• Minimum of 5 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 the pressure.
• 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:

• This role is accountable for supporting a positive developmental culture with the organization while ensuring compliance with Quality policies
• Requires good knowledge of Company Policies and Procedures and involves working towards 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, procedures and guidelines.
• 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 collaborates 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 assignment.
• Expected to handle all day to day training, learning & development queries, if major problem can refer to 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/services 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 EHS system.
• Support a culture of EHS excellence by recognizing and submitting opportunities for EHS improvement on EHS system.
• Attend all required EHS training and medical surveillance programs.
• Wear PPE as required.

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.