Project Engineer - Midlands

Project Engineer - Utilities / Facilities

About the Role:

The Facilities & Utilities Engineer will play a critical role within the Projects Department, supporting the successful delivery of facilities and utilities projects within a highly regulated pharmaceutical manufacturing environment. The primary focus of this role is to ensure that modifications, upgrades, and installations related to production processes and utility systems are executed to the highest standards of quality, safety, and compliance.

Key Responsibilities:

• Manage and oversee Facilities & Utilities projects from concept through to commissioning and handover, ensuring alignment with company goals and regulatory requirements.
• Lead modifications and upgrades to production processes, including vessel installations, chillers, emergency lighting systems, and HVAC systems.
• Develop and maintain project documentation, including Requirement Specifications, Testing Plans, Test Scripts, and Commissioning Reports.
• Coordinate with cross-functional teams, including engineering, operations, quality, and regulatory, to ensure project success.
• Conduct commissioning and qualification activities, including the execution of test plans, troubleshooting, and the resolution of discrepancies.
• Ensure compliance with FDA, GMP, and other relevant regulatory standards throughout the project lifecycle.
• Identify and manage project risks, ensuring timely mitigation strategies are implemented to avoid project delays or compliance issues.

Experience and Qualifications:

• A minimum of three years' experience working as a Project Engineer in an FDA/GMP-regulated environment.
• Previous experience in the pharmaceutical or life sciences sector is highly desirable.
• Proven experience in managing facilities and utilities projects, including working with systems such as HVAC, chillers, and emergency lighting.
• Strong knowledge of the project lifecycle, including requirement gathering, design, commissioning, and handover.
• Experience in generating and managing project documentation, including Requirement Specifications, Testing Plans, Test Scripts, and Reports.
• Familiarity with validation processes and the investigation and resolution of discrepancies during commissioning.

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 understanding of regulatory requirements for pharmaceutical facilities, including FDA and GMP guidelines.
• Effective communication and interpersonal skills to liaise with stakeholders across various departments.
• Attention to detail and a commitment to maintaining high-quality standards.
• Ability to work both independently and collaboratively in a team environment.

Desirable Qualifications:

• Degree in Mechanical, Electrical, or Process Engineering, or a related technical discipline.
• Project management certification is advantageous.
• Experience with validation software tools and systems used in the pharmaceutical sector.

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Job Type: Full-time

Schedule:

• Monday to Friday

Work Location: In person

Reference ID: JOB-312418