Use Your Power for Purpose
The primary role of the Site Calibration & Reliability Engineering SME is ownership of the instrument metrology and calibration program combined with site reliability initiatives in compliance with Pfizer policies, and procedures for the Ringaskiddy site. As Calibration & Reliability Engineering SME, you will manage the calibration program & budget, support the PM optimization program, support regulatory compliance and provide technical support for the Engineering function. You will also act as the main point of contact for calibration vendors, lead continuous improvement projects, and support regulatory investigations relating to equipment and instrumentation issues.
What You Will Achieve
Metrology Role:
Manage the logistics of the site calibration reference standard PM’s – (Collect, ship, track the assets and process the compliance documentation, arrange repairs, purchase additional units)
Support PGE, Calibration CIG and department-based site metrology / calibration improvement programs.
Manage the metrology budget - Develop, manage and control the budget for the site Reference Standards, device calibration, repair and procurement.
Technical Support:
Assist Site Plant Engineers calibration / PM related problems or queries.
Provide technical equipment / metrology / calibration support to Craft and Maintenance Team Leaders to resolve equipment and instrumentation issues.
Provide Calibration compliance support & training to the site engineering personnel.
Plant Support – Calibration trouble shooting, breakdown, root cause analysis using RFT and eliminate repeat calibration failures.
Be the point of contact for outsourced calibration queries and compliance. (IFM program or Ad-Hoc vendor calibrations)
Plant Shutdown Support – planning, organization, cost control, and execution ensuring reference standard availability.
Coordinate execution of Reliability Focus Maintenance process on existing equipment by heading a review group that consists of production, maintenance and project people.
Conducts FMEA’s and determines the optimum maintenance practices for critical systems.
Advise capital project engineers on approved manufacturers, models, spares, design aspects.
Spares technical support– Identify and set-up any critical equipment / Instrument spares for existing and new plant, refine current spares, improve descriptions, associations, repairs, and usage. Point of contact for MRO vendor & other vendor spares technical queries.
Regulatory Compliance
Represent the site as Calibration SME in audit; regulatory, HSA, corporate, Insurance etc.
Review and address calibration WO comments on a weekly basis to ensure ongoing regulatory compliance.
Review and update all calibration compliance related standards, guidelines and procedures to ensure audit readiness.
Review the existing CMMS database on a routine basis to identify & correct data integrity issues.
Supporting the Engineering Systems leader with implementation of PACE (Pfizer Asset Care Excellence)
Ensure project handover of critical instrumentation is set up correctly on EAMS (CMMS PM Setup Report review).
Continuous Improvement
Continuously refine PM and Calibration practices to maximize asset reliability and minimize lifecycle costs, including the development and optimization of existing programs on site.
Identify new instrumentation / technology that could support the site operations and craft reference standard use.
Initiate engineering CI projects to ensure that instrument related uptime and reliability is maximized, including a focus to deal with “bad actors” identified by CMMS reports on an ongoing basis.
Identify opportunities to minimize the site budget cost for calibrations. (Cal Optimization)
Play active part in achieving injury free site, e.g. Calibration Risk assessment, Risk Assessments, Work Instructions & Method statements.
Here Is What You Need
As a minimum the Site Calibration & Reliability Engineering SME shall possess a degree in Electrical/Instrumentation Engineering and have minimum of five years’ experience working in a GMP environment.
Strong ownership and accountability.
Capable of leading and working in cross functional teams.
Passion for continuous improvement.
Demonstrated problem-solving abilities.
Excellent leadership, coaching, facilitation and interpersonal skills.
Energy, enthusiasm & capability to drive change and commitment to challenge how we currently operate.
Self-starter capable of working on own initiative.
Excellent communication skills – written and verbal.
An ability to work independently and as a member of a team in a complex, fast-paced and goal driven environment.
Strong decision making capability.
Work Location Assignment: On Premise
Additional Information
In order to be considered for this position in Ireland you need to be legally eligible to work in Ireland.
Please note there is no relocation support available for this position
How to apply
Make a difference today, all suitable candidates should apply with CV below. We are looking forward to hearing from you!
Purpose
Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
Digital Transformation Strategy
One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.
Equal Employment Opportunity
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.
Disability Inclusion
Our mission is unleashing the power of all our people and we are proud to be a disability inclusive employer, ensuring equal employment opportunities for all candidates. We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career. Your journey with Pfizer starts here!