Senior Biotech Operations Project Engineer

4 weeks ago

Old Toronto Ontario, CA JobContax Full time

Are you a Senior Biotech Operations Project Engineer with 5+ years experience in a project engineering and management role in a pharmaceutical or biotech manufacturing facility engaging with site SMEs and managers along with global functions? This is a contract role based in Dun Laoghaire, Dublin.

Senior Biotech Operations Project Engineer - Dublin

Job Description

Our client is a leading international Biotechnology company with a state of the art aseptic manufacturing facility in Dun Laoghaire, South Dublin. The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment. This is an excellent opportunity to get experience into Ireland's leading aseptic manufacturing plant.

The Project Engineer – New Syringe and AVI Lines Operations Readiness will report to the Operational Readiness Programme Lead within the Operations Function. They will be responsible for providing project management and engineering support for projects in the Operations Readiness Programme for the new syringe and AVI lines.

You will have five to eight years of experience within the pharmaceutical or biotech industry and will have demonstrated project management skills.

The ideal candidate will have:
  1. Experience in a project engineering and management role in a pharmaceutical or biotech manufacturing facility engaging with site SMEs and managers along with global functions.
  2. The ability to influence and lead cross functional teams to deliver their projects that ensure a smooth start-up of the new vial filling line.
  3. The ability to work independently and identify risks and mitigation pathways to ensure project delivery.
  4. A passion for continuous improvement applied to project management.
  5. Arrange agreement among the project team, customers, and management on the goals of the project.
  6. Work with workstream leads to develop and maintain the Project schedule/plan that aligns with the overall goals of the Programme.
  7. Effectively communicate with everyone involved in the project.
  8. Have a controlled scope in place, which is understood by all stakeholders and maintained throughout completion of the project.
  9. Execute prudent risk and issue management.
  10. Maintain Actions/Risk and Decision logs.
  11. Generate and own the GMP change control.
  12. Motivate, support and direct project team members to deliver on project plan.
  13. Lead Team meetings and cross functional collaboration.
  14. Work with resource managers from across the organisation to effectively obtain and allocate resources to complete programs and projects on time.
Compliance Related Tasks:
  1. Always ensure compliance to cGMP.
  2. Ensure safety & compliance standards are maintained to the highest standards.
  3. Ensure financial compliance in line with Business & Financial guidance.
  4. Support a culture of personal responsibility within reporting structure.
Requirements
  1. Technical Degree and/or Masters’ or equivalent
  2. Experience in a Life Science / Pharmaceutical / Biotechnology Environment
Preferred Experience:
  1. Project Engineering & Management
  2. Aseptic Filling Line Operations
  3. MES/EMBR
  4. Validation
  5. Greenfield / Brownfield start up
Systems / Equipment:
  1. MS Office
  2. MS Project
  3. MS PowerPoint
  4. MS Visio
  5. Change Control & Document Management Systems
Preferred Requirements:
  1. Smartsheet
  2. High Energy and Commitment
  3. Ability to work independently.
  4. Comfortable leading across multiple stakeholders & multinational teams
  5. Strong ability to influence and affect change.
  6. Capable of resolving issues of conflict effectively
  7. Strong communicator
  8. A proven track record to transfer goals and objectives into measurable plans.
  9. Ability to identify gaps/risks and put appropriate remediation plans in place.
  10. Uses strong relationships to identify requirements and potential opportunities.
  11. Employs project management techniques and Problem Solving
  12. Provides leadership, guidance, and advice in own field of project management.
  13. Knowledge or experience with MES and EMBR projects
  14. Knowledge or experience with validation of Aseptic Filling Lines
Package

Contract role - Hourly rate €45 - €57 per hour
Minimum 12 month contract with the possibility of an extension.

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