Validation Engineer – Co. Wicklow

Role Purpose:

• Our client based in Co. Wicklow has an immediate requirement for a Validation Engineer to support their Manufacturing Sciences Department during a busy period of NPI/ Tech transfer projects on the site.
• The department is responsible for Tech transfers of new products as well as supporting and improving existing processes in a pharmaceutical plant operating to HPRA and FDA standards.
• Hybrid working; depending on training and project activity some weeks will be 100% site based and some weeks ~50:50.

Core Duties and Responsibilities:

• Provide a validation SME input and oversight to new product introduction and process development activities in manufacturing operations in Processing, Tabletting and Packaging.
• This includes the introduction of new products, materials and technologies; the discovery of process improvement opportunities and the re-development of legacy processes to increase productivity, reduce manufacturing costs and eliminate quality defects.
• Be the validation lead for these changes from an execution and oversight perspective:
  • Specific ongoing and upcoming projects include:
  • Multiple new drug product introduction on new process equipment
  • Strategic products hypercare and process support
• Roll-out of new digital tools: KNEAT for paperless validation
• There are other projects and initiatives in the planning stage and the Validation Engineer is expected to be flexible with regard to project assignment.
• The candidate is expected to liaise with local site and global company SMEs regarding change management, validation strategy and regulatory activity.

Education & Qualifications Required:

• Degree in Science/ Engineering required, ideally a Masters.
• Minimum of 3 years experience as a Validation Engineer (oversight and execution) with extensive experience in the pharmaceutical sector required.
• Experience in Process, Cleaning Hold Time Validation and Pharm Oral Solid Dosage (SOD) required.
• Experience with Veeva, SAP, Trackwise, KNEAT would be an advantage.
• Excellent project management skills with the ability to manage multiple projects simultaneously.
• The candidate should have a good understanding and experience of the following key areas:
  • Validation strategy definition
  • Validation SME from process and product perspective
  • Validation SME assessments of GMP change controls and risk assessments
  • Validation study execution and oversight
  • Audit support
  • Doc authoring for Regulatory submissions

To Apply: Quote – PE23069

If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:

14 Danville Business Park, Kilkenny, R95 F727, Ireland.
+353 56 77 90100
recruitment@prochem.ie

Click here to submit your CV

Please note, we do not require agency assistance with this role.