Location: 
Tarrytown
Employment Type: 
Contract
Job ID: 
134505
Description: 

#MON

Automation/Engineering Compliance Technical Writer - 

First Objective (75% of time): Research, author, and coordinate approval of Automated System Periodic Evaluations Reviews (PERs). These reports assess computerized systems to confirm administration activity has been performed in compliance with GMP standards and company procedures.

Second Objective (20% of time): Supply guidance for current Regeneron procedures regarding Standard Operating Procedure and System Lifecycle Document standards. Manage the review, approval, and closure of workflows for these documents.

Third Objective (5% of time): Provide support, information, and assistance to colleagues with the initiation, authorship, review, submission, and follow-up/completion of department owned non-conformance investigations, change controls, and CAPAs.

Knowledge/Experience/Education:

  • Requires BA/BS (engineering, scientific or related field preferred) and 3+ years of related experience working in a cGMP environment or in the operation of a relevant industrial facility. Biotech/Pharmaceutical Experience
  • Mastery of technical writing techniques and grammar
  • Experience in assessing manufacturing equipment, laboratory equipment, and/or computerized systems for adherence to regulatory and/or business requirements
  • Proven record of professional communication with a “Team-First” Mentality

Preferred candidates background would include working knowledge in:

  • GAMP5 Periodic Evaluation Methods and/or Continuing Qualification Methods
  • Biotech/Pharma Regulatory requirements (such as Annex 11, 21CFR Part 11, data integrity, and compliance with cGMP)
  • Process Controls Concepts
  • Computerized System Administration
  • System Design Lifecycle, Quality Risk Management, and Change Management
  • Professional Communication
  • Word processing, spreadsheet, PowerPoint and database management software

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