Job Description

  • Employment Type: Contract
  • Job Location: Dublin
  • Date Posted: Posted 4 months ago
  • Salary:Competitive

⦁ JobTitle:  Sr Validation Engineer 28888A

⦁ About Company:  Our client based in Dun Laoghaire is seeking a Sr Validation Engineer  to join its expanding team

⦁ Duration of Role:  12 months

⦁ Summary Objective:   Validation oversight of External Manufacturing sites (API, DS/DP), including process, cleaning, filter and sterilization/sanitization validation activities.

⦁ Job Duties:

• Validation document author/approver

• Ensure validated parameters are correctly incorporated in Master Batch Records

• Regulatory – Aseptic processing system oversight (media fill, autoclave validation, EM) content authorship

• Validation change control assessment

• Perform Person in Plant activities as required

• Author applicable MA filing sections

• Write/review RTQs

• Prepare inspection playbooks

• Present on topics during inspection demonstrating appropriate behaviours and knowledge of the subject areas

Requirements
SKILLS AND REQUIREMENTS (no visa processing)

• Degree qualified in science and/or engineering

• 5 + years (ideally 8 years +) biotech or pharmaceutical industry experience

• Process Validation experience

•Significant Validation experience at Aseptic Manufacturing or API facilities

• Ability to negotiate a strategic position after taking feedback from multiple sources (dealing with CMOs, communicate with others where English isn’t first language)

• Strong project management, problem-solving, and analytical skills

• Experience driving decision making

Benefits
Benefits of working with Independent Solutions

> Excellent Team of Colleagues

> Access to high-value projects

> Excellent Technical Project Managers

> Excellent pay & conditions

 

Independent Solutions are Approved Suppliers for Multinational Pharma Biotech, Medical Device, clients with locations based here in Ireland.

At Independent Solutions, we will not require you to become an employee of Independent Solutions, we will facilitate and support you to become an independent contractor, thereby reaping the maximum rewards from your contract role.

We work in the area, we know the business, we are not a recruitment agency!

We continue to partner and grow our client base and thereby ensure that we have continuous supply of excellent roles

Yes, of course we benefit from having YOU with US, but we can assure YOU that YOU too will benefit …

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