At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Lilly is currently constructing a Next Generation Biotech Drug Substance Manufacturing Facility in Limerick, Ireland. This facility will be Lilly’s most technically advanced manufacturing site and will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and increased productivity and process performance.

Main Purpose and Objectives of Position:

The primary responsibilities of the Principal Instrumentation Engineer is to provide support, direction and subject matter expertise on electrical & instrumentation issues during start up and then on into normal operations.

This role will be primarily focused on the instrumentation / calibration / regulatory side of the discipline. This person will be required to understand and own all aspects of our site calibration program and be able to talk to the site calibration programme to health authorities and regulatory bodies during audits.

The Principal Engineer also reviews our current instrument equipment performance to prevent potential reliability issues & implement reliability monitoring programs to provide maximum availability of equipment. Equipment selection for new capital projects as well as for re-capitalisation projects are at the fore front of what the engineer does while assessing the appropriate quantity of spare parts required.

Key Responsibilities:

In line with the above, the following are typically the key tasks that would be expected of the role:

Own the site calibration program.
Own and be responsible for all aspects of the instrumentation equipment installed on site, examples working on RCAi, Safety / quality deviations, equipment upgrades, obsolescence, project support, MTBF etc.
Work with and liaise with health and regulatory authorities.
Initiate and roll out new site calibration strategies and directives.
Provide engineering support to both maintenance and equipment owners in your area of expertise.
Ensure maintenance program is appropriate for reliable operation of equipment.
Provide training to Maintenance personnel on new equipment, methods & techniques.
Follow up on issues identified by equipment owner or via the maintenance Preventative Maintenance program.
Participate, raise, investigate & complete HSE & Quality observation/deviations write-ups as appropriate.
Ensure the local maintenance procedures are in line with Global Engineering Standard & Engineering Best Practices.
Ensure Job Plans, data sheets & data loaders for addition to the computerised Maintenance management systems (CMMS) are correct and contain sufficient detail.
Lead reliability improvements to identify equipment obsolescence in advance to support planned replacement vs reactive replacement using existing & developing technologies.
Identify & support continuous improvement initiatives to enhance the Maintenance program in the short & medium term to maintain a reliable plant.
Analyse predictive & condition-based monitoring data to identify follow-up actions and prioritise implementation with equipment owners.
Lead the development & contribute as SME, to site Specifications.
Develop, Review & own Departmental SOP’s.
Review Stores & Inventory levels of critical equipment.
Carry out internal audits and periodic reviews of GMP activities to ensure compliance.
Develop, review and own relevant SOP’s
Support and drive approved initiatives
Identify and lead continuous improvement initiatives to enhance maintenance program.
Ensure job plans, data sheets etc are correct and appropriately detailed.
Provide eng support to team and site for all Instrumentation related topics as needed.
Support development of calibration standards for maintenance team.
Own the measurement of uncertainty program for the site.

Educational Requirements:

Level 8 Degree in Electrical & Instrumentation Engineering or equivalent

Pre-Requisites:

5+years experience in a maintenance/engineering role, ideally within the pharmaceutical industry.
Demonstrated ability to act independently using good organisational skills.
Proven ability to make good use of systems, procedures & processes.
Working knowledge of relevant EU directives (e.g. ATEX, etc).
Familiarity with the relevant national/international engineering standards (e.g. NSAI, NECI, NEC, IEC, ISO, CEN, ISA, CENELEC etc).
Expertise in Troubleshooting and Equipment failure investigation.
Familiarity with the Global Maintenance processes & procedures.

Key Attributes:

Demonstrated technical skills in area of expertise.
Demonstrated ability to influence and to lead change.
Demonstrated aptitude and interest for problem-solving.
Demonstrated strong communication skills – oral and written.
Demonstrated ability to write technical reports.
Strong sense of customer focus and teamwork.
Demonstrated willingness to collaborate with work colleagues.
Proven flexibility to respond to equipment issues.
Proven ability to work independently and without direct supervision.
Demonstrated commitment to safety and quality in the workplace.

Personal Considerations:

At times it may be necessary to receive calls outside of normal working hours and if necessary, attendance may be required on site out of hours. At times, the person may need to travel offsite to support the business, participate in external conferences or training.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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Principal E&I Engineer – Maintenance & Reliability

Job Description