IT Patch Administrator (IT Compliance Analyst)

Location
Rensselaer, New York
Posted
Apr 19, 2018
Ref
12114BR
Required Education
Bachelors Degree
Position Type
Full time
Position Summary

Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary: The IT Patch Administrator is responsible for creating, monitoring, and improving Patch Management processes and procedures for server operating systems, Laboratory and Automation workstations, Anti-virus, as well as hardware monitoring tools. As part of the IT Compliance team the role is also responsible for ensuring that the IOPS IT group is operating in compliance with Regulatory requirements and Regeneron internal procedures.

Essential Duties and Responsibilities include, but are not limited to, the following:
• Compiles/maintains list of vendor released patches.
• Maintains record of patches applied to assets.
• Determine what needs to be patched.
• Engages with Subject Matter Experts (SMEs) that need to be involved in patch decisions as required.
• Coordinates release of patches.
• Communicates patch impacts to end users.
• Validates full deployment of patches.
• Works with Information Security to recommend continuous improvements.
• Updates dashboard metrics by System and Owner.
• Ensures IOPS IT procedures are in compliance with regulatory and corporate requirements.
• Ensures IOPS IT personnel are operating in compliance with regulations and procedures.
• Evaluates, develops and modifies IOPS IT Policies and Standard Operating Procedures to meet regulatory requirements and obligations.
• Provides IOPS IT with Technical Writing assistance.
• Works closely with QA Validation to ensure IOPS IT systems are validated and maintained in a validated state.
• Represents IOPS IT or assists IOPS IT SMEs during internal and external audits.
• Ensures IT Operational Controls are in place and maintained throughout the system lifecycle e.g. Periodic Reviews, Disaster Recovery testing, Performance Monitoring etc.
• Champions Data Integrity for all IT systems.
• Assists IOPS IT personnel in writing/responding to Deviation/Events including detailed event investigation and root cause analysis.
• Tracks and facilitates the remediation activities associated with IT-related CAPAs.
• Manages or assists IOPS IT SMEs with IOPS IT Change Controls.
• Completes GAP assessments and remediation efforts.

Knowledge and Skills:
• Knowledge of 21 CFR Part 11, Annex 11 Regulations and Good Manufacturing Practice (GMP) preferred but not required.
• Must show strong judgment and time management skills
• Ability to communicate at all levels with clarity and precision both written and verbally together with strong presentation skills
• Excellent interpersonal skills with strong customer service focus
• Ability to maintain integrity and honesty at all times
• Continuously drive to improve processes for improved performance
• May manage others through influence rather than direct authority
• Handle issues appropriately and with a sense of urgency
• Identify and effectively communicate risks
• Ability to problem solve and identify root cause

Education and Experience:
• BS/BA in related field preferred; may substitute relevant industry experience for educational requirement
• Requires 3+ years of relevant experience
• Experience in a regulated environment required; GxP preferred

Title level (Administrator/Analyst or Senior Administrator/Analyst) will be determined based on skills and experience.

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.

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Requisition Number: 12114BR