At a Glance
- Tasks: Support commissioning and qualification activities in the pharmaceutical industry.
- Company: Join a leading biotech firm focused on innovation and compliance.
- Benefits: Flexible remote work, competitive salary, and opportunities for professional growth.
- Other info: Collaborative team culture with a focus on safety and quality.
- Why this job: Make a real impact in the biotech field while developing your skills.
- Qualifications: Experience in C&Q environments and strong technical writing skills required.
The predicted salary is between 50000 - 64000 £ per year.
Key Responsibilities
- Support commissioning and qualification activities across the full C&Q lifecycle (DQ, IV, OV, PQ).
- Generate, review, and execute qualification protocols and reports in compliance with GMP and ALCOA+ principles.
- Support FAT and SAT planning, documentation review, execution, and witnessing activities.
- Review supplier documentation, RTMs, and turnover packages to ensure readiness for qualification.
- Conduct installation inspections and support commissioning activities, identifying and managing punch-list items through to closure.
- Perform risk assessments and develop task-specific method statements to support safe execution of activities.
- Provide technical troubleshooting and problem-solving support during testing and qualification phases.
- Monitor progress against project schedules and escalate risks or delays where required.
- Collaborate with engineering, quality, construction, and vendor teams to ensure compliant system delivery.
Requirements
- Experience within pharmaceutical or biotechnology commissioning and qualification environments.
- Strong understanding of the C&Q lifecycle, including URS, DQ, IV, OV, and PQ.
- Familiarity with GMP requirements, ALCOA+ principles, and controlled documentation systems.
- Experience supporting FAT, SAT, commissioning, and qualification activities.
- Strong technical writing, reporting, and communication skills.
- Ability to work independently while managing multiple priorities in a site-based environment.
ENGINEER REMOTE SUPPORT in Cheshire employer: Blackfield Associates
As an Engineer Remote Support at our company, you will be part of a dynamic team dedicated to excellence in the pharmaceutical and biotechnology sectors. We pride ourselves on fostering a collaborative work culture that encourages professional growth through continuous learning and development opportunities. Located in a vibrant area, we offer competitive benefits and a supportive environment where your contributions are valued and recognised.
We think you need these skills to ace ENGINEER REMOTE SUPPORT in Cheshire
Commissioning and Qualification (C&Q) Lifecycle
GMP Compliance
ALCOA+ Principles
Technical Troubleshooting
Risk Assessment
Method Statement Development
Technical Writing
