Facilities Compliance Specialist (technical Writer)

Regeneron

Base: $62,355.00 - $128,700.00 annually; bonus/equ...
Onsite
Bachelor's degree required
1+ to 5+ years relevant experience
Cgmp compliance knowledge
The role involves facilitating the creation, review, and revision of Standard Operating Procedures and Work Instructions for the Facilities Department

Job Summary

  • The role involves facilitating the creation, review, and revision of Standard Operating Procedures and Work Instructions for the Facilities Department.
  • Candidates must ensure cGMP compliance by managing non-conformities, Change Controls, and Corrective and Preventive Action plans.
  • Regeneron offers comprehensive benefits including health insurance, 401(k) matching, equity awards, and paid time off for eligible employees.

Matching Summary

The role involves facilitating the creation, review, and revision of Standard Operating Procedures and Work Instructions for the Facilities Department.

Salary

Base: $62,355.00 - $128,700.00 annually; Bonus/Equity: Equity awards and annual bonuses available; Benefits: Health, dental, vision, 401(k) match, PTO, parental leave

Skills & Requirements

Must-have

  • Bachelor's degree required
  • 1+ to 5+ years relevant experience
  • cGMP compliance knowledge
  • Standard Operating Procedure creation
  • Veeva software experience
  • CFR Part 11 and data integrity
  • Change Control and CAPA management

Nice-to-have

  • Experience in pharmaceutical industry
  • Knowledge of Annex 11 regulations
  • Understanding of manufacturing equipment terminology
  • Ability to prioritize multiple assignments
  • Collaborative cross-functional environment skills
  • Attention to detail and organization
  • Contractor oversight experience

Key Requirements

  • Bachelor's degree
  • 1-5+ years of relevant experience depending on level
  • Technical writing experience in manufacturing
  • Knowledge of asset maintenance and lifecycle regulations

Work Rights

Not specified

Tailored Resume

Cover Letter