Video for this job

Collins McNicholas

Process Engineer

Position Summary

The process engineer will provide project leadership and technical expertise for a new Fill/Finish facility with terminal sterilization.

Key Responsibilities

  • Client-side lead to work with equipment vendors to support the equipment lifecycle activities as part of a new facility start-up project.
  • Project management & subject matter expertise for a pharmaceutical fill/finish facility with terminal sterilization operations.
  • Equipment lifecycle support from concept design, vendor selection, detailed design, build, CQV through to commercial operation.
  • In-depth knowledge of primary vendor equipment and technology including; a bulk drug product compounding suite supplying a filling system (vial/syringe/bags) with open RABS technology and terminal sterilization.
  • In-depth knowledge of secondary vendor equipment and technology including; Parts washer, autoclave technology, and clean utility services.
  • Responsible for developing and executing the equipment lifecycle activities. This will include writing URS documents, review/approval of Design Specifications, input into the control strategy, development and execution of the test matrix (leveraged) to support offsite/onsite execution (as per ASTM E2500).
  • Experience of working with equipment vendors through the key stages of the equipment lifecycle, including; procurement, design, build, FAT, install and SAT.
  • Knowledge of supporting a ‘best practice’ methodology to help deliver a science and risk-based approach to CQV for a greenfield project start-up.
  • The candidate should have strong leadership, direction, and organizational planning skills to support the team through each stage of the project.
  • The role includes the need to develop and support the implementation of site procedures for robust and compliant GEP systems.

 Person Profile

  • Self-motivated and passionate starter.
  • Team player who embraces collaboration for project success.
  • Ideally, degree qualified; in Engineering, technical or science related field.
  • 5+ years of progressive experience in a project engineering role within a pharmaceutical (fill/finish) operation, including a thorough working knowledge of EU GMP, FDA cGMP, GAMP 5, ICH guidelines, and GEP guidelines.

For a confidential discussion and more information on the role, please contact David Lennon on 090 64 78104 or email david.lennon@collinsmcnicholas.ie

Firstname (required)

Surname (required)

Your Email (required)

Your mobile (required)

Upload CV (required)

Comment

In order to provide you with our services, we need to process certain personal information about you. We will only use your personal information to deliver the job-seeking or related services you have requested.

We seek your consent to store your data and provide you with the best possible service. If you have any questions regarding our legal obligations to you or your rights under the GDPR please refer to our privacy statement which clearly outlines all of your rights.

Related Articles

Biopharma Report

Ensuring that the supply of qualified professionals is sufficient to meet demand will be the crucial step in successfully expanding the biopharma industry in Ireland. The EGFSN (Expert Group on Future Skills Needs) estimates that 5,000 additional staff will be employed in biologics manufacturing by 2020. The number of professionals employed in the production of traditional […]
Read More