Validation Engineer - Biopharma at Dillon Engineering Services
County Sligo, County Sligo, Ireland -
Full Time


Start Date

Immediate

Expiry Date

13 May, 25

Salary

60.0

Posted On

14 Feb, 25

Experience

2 year(s) or above

Remote Job

No

Telecommute

No

Sponsor Visa

No

Skills

Validation, Oral Communication, Regulatory Requirements

Industry

Pharmaceuticals

Description

Job Title: QA Validation Engineer
Location: Sligo, Ireland
Type: Contract
Duration: 12 months
Rate: €60-€69 per hour
Ref Code: DES-957

REQUIREMENTS

  • A qualification and/or degree in an engineering or scientific discipline.
  • Over 3 years of working knowledge of cGMP, validation, and regulatory requirements in the biopharmaceutical industry.
  • Strong written and oral communication, presentation, and troubleshooting skills.
  • Experience in QA Validation of fill lines is an advantage.
  • Experience in equipment validation is highly desirable.
    For further information or a chat in confidence please reach out to Nina 087 6272369 or nina@dillones.ie.
Responsibilities
  • Coordinate and actively participate in the validation and quality assurance of site equipment, utilities, processes, and software in compliance with Company policies, FDA, European cGMP, and GAMP standards.
  • Develop and execute the Site Validation Master Plan.
  • Create and execute Project Validation Plans and schedules.
  • Prepare validation protocols and final reports, ensuring they meet cGMP standards.
  • Manage validation investigations and implement corrective actions as needed.
  • Review and approve various quality documents and test data.
  • Manage validation, exception event, and change control processes.
  • Maintain and track validation equipment (if applicable).
  • Participate in continuous improvement programs to enhance manufacturing, quality, safety, and training systems.
  • Coordinate activities to maximize team efficiency.
  • Provide cross-training within the team and train new team members as necessary.
  • Ensure cGMP compliance of production areas.
  • Communicate regularly with peers and management regarding activities, escalating issues or concerns as necessary.
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