Project Engineer

Project Engineer Role

Department: Engineering

Position Reports to: The Design Manager

Job Purpose

Lead elements of all engineering design, construction, commissioning, and verification activities to enable the introduction of a new process to the site.

Responsibilities

Design

Responsible for all design:

• Includes process and non-process systems (Process, Civil Structural, Architectural, HVAC, BMS/qBMS, E&I, Piping, and Fire Safety).

Coordination Support:

• Provide design and coordination support between the site and the appointed A&E firm.

Project Controls:

• Work collaboratively with the Controls Lead and Project Lead on:
• Cost control
• Management of cost allocation
• Document control
• Support the process design lead.

3D Model Management:

• Coordinate model reviews with the engineering firm.
• Define breakdown of facilities into model areas and schedule completion to align with the construction schedule.
• Review clash detection reports and ensure quality checks

Schedule Management:

• Build, track, and manage the project schedule from design through to verification completion.

Procurement:

• Collaborate with the procurement team to manage the procurement effort, including:
• Agreeing on the procurement plan (vendor list and requisition list).
• Approving TBAs, vendor selection, inspection, and test plans.
• Managing subcontract strategy.

Construction

• Develop and oversee the construction management strategy, including deliverables through the Construction Manager and team.

Safety:

• Establish safety programs and procedures in collaboration with the Construction Manager.

Quality Control:

• Help establish Construction Quality Control plans, leveraging experience from previous projects.
• Oversee trade contractor selection and performance reviews.
• Ensure alignment of the construction schedule with the overall project schedule.

Verification (Commissioning and Qualification)

• Develop a verification strategy for all new process, facility, and utility systems.
• Approve necessary change controls supporting the project.
• Manage the creation and execution of documentation for cGMP verification of systems, equipment, and manufacturing processes, including protocols and reports.
• Oversee PQ qualification of systems as required.
• Coordinate technical and compliance reviews of testing protocols and reports.
• Operate according to SOPs developed for verification, validation, validated operations, and cGMP compliance.

Education/Experience

Educational Requirements

• Minimum qualification: B.Eng. degree in life sciences or an engineering discipline.

Minimum Experience

• Experience with Oral Solid Dose equipment and facility design and commissioning.
• Proven ability to manage or participate in a leadership capacity on one or more large capital projects (≥ €10MM).
• Familiarity with large project procurement and construction approaches.
• Minimum of 4 years of validation experience within a pharmaceutical GMP manufacturing environment.

Additional Skills (Highly Desirable)

• Knowledge and experience with plant start-ups.
• Familiarity with operating in a fully automated plant environment.
• Strong communication skills.
• Experience in process plant commissioning alongside or within operating GMP suites.
• Familiarity with ASTM E2500 standards.

Job Type: Full-time

Expected hours: 40 per week

Benefits:

• On-site parking

Flexible language requirement:

• English not required

Schedule:

• Monday to Friday

Application question(s):

• How many years experience do you have with Oral Solid Dose equipment?

Education:

• Bachelor's (preferred)

Work Location: In person

Reference ID: 312602