Validation Engineer - Waterford

Company: Confidential
Your Application: You have not applied yet
Location: Waterford, Irlanda
JOB DESCRIPTION


Job Summary

Waterford
Permanent
1779
Jul 05, 2022
Competitive

Job Description

The purpose of this position is to be the subject matter expert in our Fill Finish validation operation and be a recognised expert in this industry.

Qualifications and Skills Required

Bachelor's degree (or equivalent) in Science (Chemistry, Microbiology, or Pharmacy preferred) or Engineering (Chemical/Mechanical)

Further qualifications (e.g. Masters) preferred.

At least 12+ years relevant experience in a pharmaceutical manufacturing environment, with at least 6+ years' experience in a comparable Validation Engineering role.

Must have experience working in a sterile manufacturing environment.

Requires prior

experience performing validations of multiple systems and equipment in a time-sensitive start-up program.

Knowledge of requirements for design, installation, commissioning, qualification and validation of pharmaceutical equipment, systems and utilities using risk-based approaches.

Knowledge of leveraging test data from early stage project testing into later stages (e.g. FAT into SAT/IOQ).

Knowledge of regulatory validation requirements including FDA, EMA and all other applicable worldwide Regulatory requirements (ICH Q7, Q8, Q9).

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JOB TYPE
Work Day: Full Time
Employment type: Permanent Job
Salary: Negotiable


JOB REQUIREMENTS
Minimal experience: Unspecified



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