QA Validation Engineer

4 weeks ago

Sligo, Sligo, Ireland SL Controls Ltd Full time
Overview

Join to apply for the QA Validation Engineer role at SL Controls Ltd.

Role brief and responsibilities are described below. This role is onsite in Sligo and may be offered as a permanent or contractor opportunity.

Role
  • Role: QA Validation Engineer
  • Location: Sligo
  • Engagement: Onsite
  • Employment type: Permanent or Contractor
Responsibilities
  • Coordinate and participate in the validation and quality assurance of site equipment, utilities, processes and software in compliance with client policies, FDA, European cGMP and GAMP standards.
  • Generate, maintain and execute the Site Validation Master Plan.
  • Generate, maintain and execute Project Validation Plans and schedules.
  • Create validation protocols and final reports to cGMP standards.
  • Generate validation investigations and implement corrective actions.
  • Create and review quality documents and test data.
  • Manage validation, exception event, and change control processes.
  • Maintain and track validation equipment, where applicable.
  • Document all activities in line with cGMP requirements and ensure overall cGMP compliance of production areas.
Qualifications
  • Over 2 years of validation experience in medical device plastics processing, molding or assembly operations.
  • Knowledge of cGMP and regulatory requirements relating to the medical device industry.
  • Strong documentation and review skills.
  • Experience developing and maintaining a site validation master plan within the Medical Devices or Life Sciences manufacturing sector.
Person Spec
  • Bachelor's degree in Computer Science, Electrical Engineering, Systems Engineering, Technology or a related discipline with over 3 years of Validation Engineering experience.
  • At least 2 years of validation activities for equipment in Medical Devices, Pharmaceutical or other GMP-regulated environments.
  • Excellent collaboration, communication, and attention to detail; strong understanding of validation concepts and documentation.
  • Proven ability to solve complex technical and equipment qualification challenges using a rational, scientific approach.
  • The candidate should be based in Sligo or within a reasonable commute or be willing to relocate to the area as the role is onsite.
Company & Opportunity

NNIT offers a supportive environment with employee development and wellness initiatives, along with a competitive compensation package. SL Controls provides Equipment System Integration solutions to manufacturers, particularly in life sciences and technology sectors. Roles are based in various locations across Ireland as well as in the USA, with opportunities for career progression.


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