Aseptic Processing Engineer

5 days ago


Ballina, Mayo County, Ireland Gertek Project Management Full time

Gertek Project Management is dedicated to providing project management, talent solutions, and commissioning qualification and validation services to life science and technology companies.

We partner with these companies to deliver their most strategic and important projects.

The Project Development Specialist plays a critical role in ensuring that projects meet agreed goals/targets on time and on budget.

The specialist works closely with the Senior Manager of Aseptic Engineering to provide advice and support to ensure the equipment/facility/utilities design and goals/targets are achieved.


Main tasks:
  • Leading cross-functional project teams to deliver processing equipment to the site based on planned timelines and scope.
  • Writing user requirement specifications.
  • Selecting vendors and completing vendor evaluation matrices.
  • Writing RCEs, placing orders, managing projects, and conducting design reviews.
  • Working to ASME BPE 2019 standards and relevant ISPE guidelines.
  • Coordinating the installation and service connections for processing equipment, working with equipment vendors and engineering personnel.
  • Participating in factory acceptance testing programs.
  • Coordinating all equipment documentation requirements.
  • Commissioning equipment and providing engineering support during qualification.
  • Working with the E&T Senior Manager and system owner/project team.
  • Handing over training, coordinating O&M manuals, spare parts, and PM schedules.
  • Contributing to team environments on specific technical problem-solving forums associated with product manufacture and aseptic filling.
  • Delivering process improvement/cost reduction projects.
  • Leading regular project review meetings with the project team.
  • Attending tier 1 meetings with the manager.

Requirements:
  • Bachelor's degree in an engineering discipline or equivalent experience.
  • Minimum 2-5 years of experience working in pharmaceuticals.
  • Proven track record of project management experience.
  • A self-starter with strong technical skills.
  • Excellent communication and interpersonal skills for operating in a multi-functional project team setup.
  • Ability to work within a team, taking initiative to articulate and deliver specific functional requirements for all project aspects and work with members of various disciplines and functions across the project.
  • Strong team leadership skills and ability to work closely with other departments within an organisation.
  • Advantageous to have commissioning and cycle development/validation/start-up experience, especially in E&I for vessels and control systems.

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