Lab Instrument Validation Engineer

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Job description

Job Title: Laboratory Instrument Onboarding Engineer
Location: County Limerick

Our global client create the instruments, tests and software used by scientists, researchers and clinicians to address the most critical challenges across science and healthcare including the COVID-19 pandemic. Strategically partnering with customers to enable earlier, and more accurate insights, supported by deep market knowledge and expertise and a reason why we are seeking a highly skilled professional with Laboratory Instrument to perform a Validation Engineer role based in Limerick. This role would suit a Customer Service or Field Service Engineer with expertise in lab instruments / test equipment to be based full time on a customer site in Limerick. This role is more paperwork compliance related, maintaining qualification and validation documentation for the installation of lab instruments (not maintenance or fixing of instruments)

Job Description Summary
Performs the calibration and validation of test and data analysis equipment and systems used for clinical research, trials and product testing. Assists in equipment selection, specification and negotiation of competitive pricing. Maintains all documentation pertaining to qualification and validation. May develop procedures and/or protocols. Also serves as information resource for validation technicians, contractors and vendors. This role is intended for use by companies in the Life Sciences and Medical Device industries and should be used for those individuals validating results for clinical research, clinical trials and manufacturing testing.

Support Installation and Qualification of Lab Systems
Core Job Duties:
* Commissioning, Qualification, and Validation of many different types of lab instrumentation and equipment
* Technical contribution for Qualification and Validation Documents (e.g. Risk Assessment, Validation Plan, Design Configuration/Specification, User Requirements, Functional Requirements, IQ OQ PQ, Trace Matrix, Validation Summary Report), SOPs, Maintenance Procedures, Calibration Procedures, and other instrument support documents
* Provide support for the translation of technical information and requirements into qualification/validation test design
* Escort and coordinate with instrument vendor service engineers and review vendor qualification documentation

Qualifications, Skills & Experience:
* Bachelor's Degree; scientific background preferred
* At least 3-5 years of pharmaceutical of FDA related validation experience
* Good knowledge of GMPs, 21CFR Part 11, USP 1058, GAMP 5 - and other relevant industry regulations and guidance
* Strong interpersonal skills and demonstrated ability work independently
* Organized and task oriented
* Excellent written and oral communication skills - especially on technical topics
* Self-directed and motivated individual who is able to operate in a rapidly changing business environment
* Customer-oriented, conducting job function with a primary focus on customer satisfaction (internal & external) and ability to deal with customer complaints
* Must have a strong command of Microsoft Office Word and Excel and Adobe Acrobat, Microsoft Project
* Ability to Build consensus among team of stakeholders
* Excellent critical thinking/analytical and problem solving skills
* Experience with a multitude of laboratory equipment a plus
Work Conditions:
Lab Environment (may need to follow Personal Protective Equipment and Safety Polices); Office Environment

If you are interested and feel you have the right skills then please apply to this role.

Gi Group Pharmaceuticals provides a tailored Account Managed Service and dedicated Pharmaceutical recruitment team and partners with many different Pharmaceutical and Biotechnology clients throughout the globe and the United Kingdom.
Gi Group Holdings Recruitment Limited group of companies includes Gi Recruitment Limited, Draefern Limited, Gi Group Recruitment Ltd, INTOO (UK) Limited, Marks Sattin (UK) Limited, TACK TMI UK Limited and Grafton Professional Staffing Limited. We are committed to protecting the privacy of all of our candidates and clients. Following some recent changes to data protection laws we have updated our Privacy Policy. To view a copy and to help you understand how we collect, use and process your personal data please visit the Privacy page on our Gi Group UK website.