Validation Engineer Ii

American Regent Inc

Remote
**
Develop and execute validation plans
Support qualification and validation of pharmaceutical manufacturing processes
Ensure facility, systems, and processes comply with gmps
** American Regent Inc. is seeking a Validation Engineer II to develop and execute validation plans and protocols for pharmaceutical manufacturing processes. This remote position requires expertise in validation within the pharmaceutical industry, focusing on compliance with cGMP regulations. **

Job Summary

  • The Validation Engineer II will develop and execute validation plans, protocols and reports that support the business needs of the company.
  • The position will oversee and support the qualification and validation of the pharmaceutical manufacturing processes and ensure that the facility, systems and processes perform according to internal specifications, comply with current GMPs and are maintained in a validated state.
  • Remain current with FDA guidance’s and requirements regarding the validation of aseptic manufacturing processes; ensures all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP and health and safety requirements.

Matching Summary

Match Score: 75

** American Regent Inc. is seeking a Validation Engineer II to develop and execute validation plans and protocols for pharmaceutical manufacturing processes. This remote position requires expertise in validation within the pharmaceutical industry, focusing on compliance with cGMP regulations. **

Skills & Requirements

Must-have

  • Develop and execute validation plans
  • Support qualification and validation of pharmaceutical manufacturing processes
  • Ensure facility, systems, and processes comply with GMPs
  • Subject Matter Expert (SME) for Packaging, Equipment, Facilities, or Cleaning Validation
  • Maintain life cycle documentation for equipment and systems
  • Provide technical input for validation deviations and change requests
  • Interface with Quality, Manufacturing, Packaging, and Engineering groups

Nice-to-have

  • Work independently with minimum supervision
  • Mentor and direct junior team members
  • Work within a team-oriented environment

Key Requirements

  • Bachelor’s Degree in Life Sciences, Engineering or equivalent and 3 years of validation experience
  • Associate’s Degree and 5 years of validation experience
  • High School Diploma / GED and 8 years experience
  • Strong knowledge of cGMP regulations and practices
  • Ability to read/interpret engineering drawings
  • Strong knowledge of MS-Office software
  • Good technical writing skills
  • Excellent communication, problem-solving, planning and organization skills
  • Ability to work overtime as needed
  • Travel may be required (<10%)

Work Rights

Not specified

Tailored Resume

Cover Letter