Job Description

We are seeking a highly skilled, self-motivated Senior Validation Specialist- CSV to ensure compliance of computerized systems with regulatory requirements in the life sciences industry as a part of Regeneron Cell Medicines (RCM), a newly formed research & development (R&D) unit to advance cell therapies and combination approaches in oncology and immunology. You will be responsible for planning, executing, and documenting validation activities to meet FDA and potentially other global regulatory standards such as 21 CFR Part 11, GAMP 5, and Annex 11.

As a Senior Validation Specialist, a typical day might include:

• Planning and driving all CSV activities required to maintain quality compliance as per existing Policies and Procedures for RCM.

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

• Creating and maintaining validation documentation, including Validation Plans, Risk Assessments, Test Scripts and Reports.

• Identifying current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation, and maintenance of the procedures, actions, and documentation to ensure compliance within the operation.

• Supporting regulator’s inspections and audits by providing validation documentation and explanations and communicates company’s computer validation policies.

• Generating, reviewing, editing, and approving change controls, impact assessments, SOPs, reports, as well as deviation notifications/investigations

• Collaborating with IT, Automation, Quality Assurance and End Users to ensure system compliance as well as with outside contractors/vendors to complete validation tasks

• Managing contingent workers as needed

This role might be for you if you:

• Have excellent verbal and written communication skills

• Are continuously driving for improved processes for more efficient performance

• Have the ability to work collaboratively as a part of a team

• Can be flexible with shifting priorities

In order to be considered for this role, you must have at least a BS/BA in Computer Science, Engineering, Chemistry, or Life Sciences and 5+ years of relevant work experience. Must have experience in a pharmaceutical or biopharmaceutical manufacturing facility; GMP experience is required. Experience with ERP, LIMS, QMS and other GxP-regulated computerized systems and analytical instruments is required.

This role is on-site in Cambridge, MA.

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.

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