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About the Role

Support validation of equipment, utilities, software, cleaning and sterilization processes in accordance with regulatory requirements by implementing company manufacturing standard policies and procedures.

Responsibilities

• Generate, execute and/or review master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria.
• Analyze the results of testing and determine the acceptability of results against pre-determined criteria.
• Investigate and troubleshoot problems which occur during validations and determine solutions or recommendation for changes and/or improvements.
• Coordinate with functional departments to resolve issues from validations.
• Review, edit and approve deviation notifications, deviation investigations and corrective actions.
• Coordinate with other departments or outside contractors/vendors to complete validation tasks.
• Develop a tracking mechanism of validation activity completion for various projects and prepare status reports.
• Present validation project and program status reports to senior management on a routine basis.
• Ensure that validation status is maintained for equipment and software use in commercial and clinical manufacturing.
• Stay current with industry trends, regulatory requirement updates and communicate to teams.
• May present at both internal and external (regulatory) audits.

Requirements

• B.S in life sciences or related field; may substitute proven experience for education requirement.
• QA Validation Specialist: 4 + years of experience.
• Sr. QA Validation Specialist: 6+ years of experience.
• Level will be determined based on experience.

Location

• Rensselaer, New York, United States

Work Type

• On-site

Experience Level

• Senior

Education Level

• Bachelor's Degree

Salary/Compensations

• $67,400.00 - $128,700.00

Benefits

• Student loan paydown program & tuition reimbursement
• Family care benefits
• Relocation assistance
• Inclusion, culture and well-being programs (including physical & mental health)
• 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
• Family support benefits

About the Company

• Regeneron uses science and innovation to develop life-changing medicines for people with serious diseases.
• This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
• We believe we do our best work when we are together.
• 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.

Equal Opportunity

• 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.