Regeneron Pharmaceuticals QA Validation Specialist in East Greenbush, New York
We are currently looking to add a QA Validation Specialist to our growing team. This position will validate and qualify equipment, systems, and processes in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures. This role is mainly focused on packaging and assembly equipment.
Please note this will be a Monday-Friday 1st shift 8:00am-4:30pm position for approximately 6 months for training. Working hours thereafter will be 2nd shift 2:00pm-10:30pm Monday-Friday.
In this role, a typical day might include the following:
Working across multi-functional teams to support our newly constructed Fill Finish facility.
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
Analyzing the results of testing and deciding the acceptability of results against pre-determined criteria
Investigating and troubleshooting problems which occur and determining solutions or recommendations for changes and/or improvements
Reviewing, editing and approving deviation notifications, deviation investigations, corrective actions, change controls, SOPs, reports and other documentation
Travel up to 15%, domestic and international
This role might be for you if you:
Have validation experience; packaging or assembly experience is helpful
Can coordinate with other departments or outside contractors/vendors to complete validation tasks
You continuously seek to improve processes for improved performance
Are willing and able to work Monday-Friday 2:00pm-10:30pm after approximately 6 months of training Monday-Friday 8:00am-4:30pm
To be considered for this role you must hold a Bachelor’s degree in Engineering, Chemistry, or Life Sciences with the following amount of relevant experience for each level:
Associate Specialist – 1+ years
Specialist – 2+ years
Senior Specialist – 5+ years
We may substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!
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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
Salary Range (annually)
$55,700.00 - $121,300.00
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