Job Description
My client a leading Biopharmaceutical company now require a Senior Calibration Engineer to join their expanding team. This is a permanent position.
The Senior Calibration Engineer will design and implement the calibration programme for a new single use multi-product biotech facility. The role will be the Calibration Subject Matter Expert (SME) in the establishment of the calibration programme, performing maintenance, installation, troubleshooting, calibration and repair of a variety of electronic components, analytical equipment, controls and instruments for site wide laboratory and manufacturing equipment.
Responsibilities of Senior Calibration Engineer
- Provide technical direction, supervision and input for standing up and operation of the calibration programme at the facility to meet functional and site objectives.
- Responsible for identifying and critically assessing the calibration requirements for plant and equipment, drafting and implementing guidelines, standards and calibration procedures, setting out the calibration plans and schedules, conducting technical investigations, resolving calibration deviations, act as SME presenting at internal and external audits, developing and delivering training, and managing technical specifications and documentation.
- Perform monitoring, trending of equipment and processes, and determine acceptability and tolerance requirements based on data analysis and specification.
- Assist with vendor calibration support to equipment; including audits and contracted services to per site requirements.
- Set up standards and special laboratory equipment to test, evaluate, and calibrate instruments, sensors and equipment.
- Assist engineers in evaluation plans and procedures, to maintain precision accuracy of measuring, recording and indicating instruments and equipment.
- Investigate failures and instruments that are out of tolerance, and determine acceptability of product and processes. Assist in the preparation of documentation of investigation findings.
- Assists with development and implementation of technically defensible calibration procedures and new instruments being considered at the Facility.
- Build and maintain relationships with customers with the concept that metrology is a service provider to the customer.
- Coordinates the assigned activities and schedules of calibrations throughout the facility, including routine and non-routine work.
- Makes scientific judgments related to instrumentation problem solving.
- Enshrines safety, quality and operational excellence in the application calibration across site.
- Subject Matter Expert and leader for the site calibration programme who works with cross-functional teams to ensure that there is an effective and robust calibration system developed and implemented at the site.
- Responsible for generating of calibration documents, specifications, training programs, and for standing-up the Plant Calibration system, generating and managing Standard Operating Procedures, Protocols, Technical Reports and QMS reports.
- Ensure that calibration improvement projects are included in the capital plan.
- Participate in the Site Operations Readiness team interfacing with the projects team to ensure that the project is delivered in accordance with the agreed scope.
- Work with Maintenance Lead in establishing and meeting targeted site and Tech Ops objectives, ensuring department objectives are aligned, translated to all and visually managed to drive performance results.
- Conducts performance reviews and development plans.
- Ensure that calibration budgets are met and adjusted as needed.
- A minimum of a Bachelor's degree or Diploma in Metrology or Instrumentation or equivalent
- At least 8 years' industrial experience, with at least 5 years in pharmaceutical manufacturing, medical devices or equivalent
- Must have knowledge of Metrology concepts, including accuracy, precision and uncertainty. Must be able to deal with complex processes
- A relevant postgraduate qualification in validation, engineering, automation or TPM is desirable
- Operational Excellence/ Lean Six Sigma qualification or competency in leading, training and/or implementing root cause analysis and effective investigation practices
- A background of working in advanced automated manufacturing operations with integrated sophisticated processes
- Must be open to the possibility of travel albeit a small percentage
The RFT Group, BioPharmaceutical Division specialize exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors.
For more information please contact John at The RFT Group / www.rftgroup.ie / 01 2302400 or click apply below