Project Engineer

7 days ago

Maynooth, Co Kildare, Ireland DPS Group Global Full time

About the Role:

The Project Engineer will play a critical role in managing and delivering site capital projects, including facilities, utilities, and equipment upgrades, in a highly regulated pharmaceutical manufacturing environment. This role involves overseeing projects from concept to handover, ensuring alignment with company goals, regulatory requirements, and best practices in health, safety, and environmental standards. The successful candidate will contribute to the continuous improvement of systems and processes, ensuring high-quality outcomes and minimal disruption to operations.

Key Responsibilities:

  • Manage and oversee facilities, utilities, and equipment projects from initiation to commissioning and handover, ensuring compliance with FDA, GMP, and other relevant regulations.
  • Lead modifications and upgrades to production processes and utility systems, including vessel installations, chillers, HVAC systems, emergency lighting, and pharmaceutical process equipment.
  • Develop and maintain detailed project documentation, including Requirement Specifications, Testing Plans, Test Scripts, Commissioning Reports, and validation protocols.
  • Prepare capital expenditure requests, cost estimates, and monitor project budgets to ensure projects are delivered on time and within budget.
  • Supervise contractors and ensure project work is completed to the highest quality, safety, and environmental standards.
  • Conduct commissioning, qualification, and troubleshooting activities, resolving discrepancies throughout the project lifecycle.
  • Collaborate with cross-functional teams, including engineering, operations, quality, and regulatory, to ensure seamless integration of projects into operational areas.
  • Identify and manage project risks, implementing mitigation strategies to avoid delays and compliance issues.
  • Support the implementation and improvement of technical standards and best practices across projects.
  • Represent the function on cross-functional initiatives and communicate decisions effectively to site middle and senior management.
  • Challenge current methods and practices, offering innovative solutions to enhance performance and efficiency.

Experience and Qualifications:

Required:

  • Bachelor's Degree in Engineering (Mechanical, Electrical, Chemical, or Process) or equivalent.
  • 5-10 years of relevant experience in facilities, utilities, and equipment projects, preferably in an FDA/GMP-regulated pharmaceutical or life sciences environment.
  • Proven experience in the design, purchase, installation, and upgrades of pharmaceutical process equipment and utility systems such as HVAC, chillers, and emergency lighting.
  • Strong knowledge of the project lifecycle, including requirement gathering, design, commissioning, and handover.
  • Demonstrated application of scientific and engineering methods to deliver effective problem-solving.
  • Familiarity with validation processes and investigating discrepancies during commissioning.

Preferred:

  • PMP Project Management Qualification or similar certification.
  • Experience with Drug Product, Filling, OSD (Oral Solid Dose) Equipment, Medical Device Equipment, or Packaging systems.

Skills and Competencies:

  • Strong project management skills with the ability to manage multiple projects simultaneously.
  • Excellent problem-solving and troubleshooting abilities, particularly in identifying and resolving commissioning issues.
  • Strong leadership, collaborative, and communication skills, with the ability to work independently and within a team environment.
  • Effective verbal and written communication skills, including group presentations, active listening, and empathy.
  • Attention to detail and commitment to maintaining high-quality standards.
  • Business acumen to make decisions that align with site strategy while ensuring compliance with regulatory and legal requirements.

About the Company:

The company is a leading pharmaceutical manufacturer committed to producing high-quality, life-saving medicines. With state-of-the-art facilities and a strong focus on innovation, the company offers opportunities for engineering professionals passionate about making a difference in the healthcare sector.

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