Senior QA Validation Specialist

BioSpace; Ireland (WV); On-site; USD 61,000 - 99,000; Full time

Job summary

Regeneron is seeking a Senior QA Validation Specialist to join our Quality Assurance team in Ireland. The role involves generating, executing and reviewing qualification and validation protocols, analyzing testing results, and coordinating with contractors to complete validation tasks. Some travel may be required.

You will need a BS/BA in Engineering, Chemistry or Life Science and at least 5–8 years of commissioning/qualification experience with large-scale process equipment. Thrive today.

Qualifications

• BS/BA in Engineering, Chemistry or Life Science.
• 5–8+ years proven experience in Commissioning / Qualification with Large Scale Process equipment.
• Experience generating, executing and reviewing qualification and validation protocols and summary reports.

Responsibilities

• Generating, executing and/or reviewing master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria
• Analysing the results of testing and determines the acceptability of results against pre-determined criteria
• Investigating and troubleshooting problems which occur and determines solutions or recommendations for changes and/or improvements
• Reviewing, editing and approval deviation notifications, deviation investigations, and corrective actions
• Reviewing and approval of change controls, SOPs, reports and other documentation
• Coordinating with other departments or outside contractors/vendors to complete validation tasks
• Managing projects and prepares status reports
• Providing oversight to contingent workers may be a requirement

Education

BS/BA in Engineering, Chemistry or Life Science

Job description

Build Our Future Together

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Regeneron is currently seeking a Senior QA Validation Specialist to join our Quality Assurance team.

This position offers the opportunity to contribute to a fast-growing, science-driven organisation making a meaningful difference to patients worldwide.

Where

Location: Raheen, Limerick

Some travel may be required.

What Youll Do

• Generating, executing and/or reviewing master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria


• Analysing the results of testing and determines the acceptability of results against pre-determined criteria


• Investigating and troubleshooting problems which occur and determines solutions or recommendations for changes and/or improvements


• Reviewing, editing and approval deviation notifications, deviation investigations, and corrective actions


• Reviewing and approval of change controls, SOPs, reports and other documentation


• Coordinating with other departments or outside contractors/vendors to complete validation tasks


• Managing projects and prepares status reports


• Providing oversight to contingent workers may be a requirement

The Environment And Physical Rhythms Of This Role

• Ability to work independently or as part of a team


• Ability to communicate with transparency


• Meets commitments on scope and on time


• Follows directions, performs well-defined tasks


• Effective time management skills

Lets Find Out If Were a Fit

To be considered for this opportunity you must have a BS/BA in Engineering, Chemistry or Life Science and requires at least 5 8+ years proven experience in Commissioning / Qualification experience with Large Scale Process equipment

Thrive today. Grow tomorrow.

#IRELIM #JOBSIEST #REGNIEQA #REGNQA

Does this sound like you? We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

54,200.00 - 88,400.00