Project Engineer

SRG; Norwich; On-site; GBP 40,000 - 55,000; Full time

Job summary

A leading company in the regulated manufacturing sector is seeking a Project/Quality Engineer to manage engineering projects and ensure compliance with GMP standards. You'll optimize equipment performance and lead validation activities while driving continuous improvement initiatives. Ideal candidates should possess strong project management skills and a solid understanding of GMP compliance.

Qualifications

• Experience in project management and/or quality engineering within a GMP-regulated environment.
• Strong understanding of GMP compliance and engineering change management.
• Ability to manage documentation, budgets, and schedules.

Responsibilities

• Manage and deliver engineering projects including process upgrades on time.
• Support operations by optimizing equipment performance.
• Coordinate validation activities to ensure regulatory compliance.

Skills

Project management

Quality engineering

GMP compliance

Equipment validation

Problem-solving

Teamwork

Job description

Job Title: Project/Quality Engineer

Role Purpose:

The Project/Quality Engineer will play a key role in delivering engineering projects and ensuring quality and compliance within a regulated manufacturing environment. This role involves managing capital projects, supporting equipment validation, and driving continuous improvement to enhance safety, quality, and operational efficiency.

Key Responsibilities:

• Manage and deliver engineering projects including process, packaging, and civil upgrades on time and within budget.
• Prepare project scopes, financial justifications, and detailed plans; monitor contractors and oversee project execution.
• Support manufacturing operations by optimizing equipment performance and adopting new technologies.
• Coordinate and lead validation and revalidation activities for GMP-critical equipment, ensuring compliance with regulatory standards.
• Oversee engineering change controls, CAPAs, and quality documentation related to validation and operational equipment.
• Develop, execute, and report on validation protocols and qualification requirements (URS, DQ, FAT, IQ, OQ, PQ).
• Maintain a safe work environment by identifying hazards, reporting incidents, and promoting safety best practices.
• Contribute to risk assessments, root cause analysis, and continuous improvement initiatives targeting efficiency, cost reduction, quality enhancement, safety, flexibility, and delivery performance.
• Participate in internal audits and support continuous improvement projects across engineering and validation functions.
• Communicate progress and challenges effectively to management and team members.

Skills and Experience:

• Experience in project management and/or quality engineering within a GMP-regulated manufacturing setting.
• Strong understanding of GMP compliance, equipment validation, and engineering change management.
• Ability to manage project documentation, budgets, and schedules.
• Problem-solving skills with a proactive approach to continuous improvement.
• Good communication and teamwork skills.