QA Validation Specialist/Assoc Specialist (Large Equipment& Utilities) (Multi-level)
Join to apply for the QA Validation Specialist/Assoc Specialist (Large Equipment& Utilities) (Multi-level) role at Regeneron
QA Validation Specialist/Assoc Specialist (Large Equipment& Utilities) (Multi-level)
Join to apply for the QA Validation Specialist/Assoc Specialist (Large Equipment& Utilities) (Multi-level) role at Regeneron
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Within this role you'll be responsible for qualification activities for equipment, utilities and systems in accordance with cGxP, regulatory requirements and industry trends within the frame of Industrial Operations and major capacity expansion and transformation projects for the delivery of highly digitalized and automated suites for the production (upstream, downstream) of drug substance for biologics.
A typical day might include, but is not limited to, the following:
* 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
This Role May Be For You If You Have
* Ability to work independently or as part of a team
* Ability to communicate with transparency
* Demonstrate respectful behavior at all times
* Gathers and organizes information
* Meets commitments on scope, on time
* Follows directions, performs well-defined tasks
* Effective time management skills
* Seeks to identify continuous improvement needs
To be considered for this opportunity you must have a BS/BA in Engineering, Chemistry or Life Science. Associate Level requires 0-2 years experience, for Specialist level 3+ years experience is required directly related experience
#IREADV #JOBSIEPR #REGNIEQA
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, 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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Seniority level
* Seniority level
Not Applicable
Employment type
* Employment type
Full-time
Job function
* Job function
Quality Assurance
* Industries
Biotechnology
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