Job Title: Equipment Validation Engineer
Contract Length: 12 Months
Location/onsite requirements: Cambridgeshire

Job Overview: We are seeking a highly skilled and detail-oriented Equipment Validation Engineer to join our team. This role is responsible for ensuring the validation and qualification of all manufacturing and laboratory equipment, ensuring compliance with regulatory standards such as cGMP and FDA guidelines. The Equipment Validation Engineer will manage and execute validation activities across the equipment lifecycle, from installation to ongoing performance qualification, ensuring that equipment operates efficiently and in compliance with industry standards.

Key Responsibilities:

• Lead the validation and qualification activities for new and existing manufacturing, laboratory, and packaging equipment.
• Develop and review validation documents, including Equipment Qualification (IQ/OQ/PQ) protocols, Risk Assessments, and related technical documentation.
• Oversee the installation, operation, and performance qualification of equipment, ensuring adherence to project timelines and regulatory requirements.
• Work with cross-functional teams (Engineering, Quality, Manufacturing, IT) to define and execute equipment validation protocols.
• Ensure that all equipment is validated in accordance with current Good Manufacturing Practices (cGMP) and other relevant regulatory requirements (FDA, EMA, etc.).
• Prepare and maintain detailed validation reports, documenting results and deviations, and providing recommendations for corrective actions when necessary.
• Identify and assess risks related to equipment performance and support risk mitigation strategies during the qualification process.
• Participate in troubleshooting activities, identifying root causes, and implementing corrective actions for equipment-related issues.
• Collaborate with maintenance teams to ensure proper ongoing qualification and calibration programs for validated equipment.
• Manage equipment requalification activities in response to changes in equipment, processes, or regulatory requirements.
• Support the development and review of Standard Operating Procedures (SOPs) for equipment operation and qualification.
• Ensure compliance with equipment validation documentation and handle deviations, CAPAs, and other regulatory requirements as needed.
• Stay informed about industry best practices, emerging technologies, and regulatory updates related to equipment validation.

Education & Experience Requirements:

• Education: Bachelor’s Degree in Engineering, Life Sciences, or a related technical field.
• Experience: 4+ years of experience in equipment validation in a regulated industry, preferably in pharmaceuticals, biotechnology, or medical devices.
• Experience with cGMP and FDA regulations governing equipment qualification and validation processes.

Skills & Qualifications:

• Strong knowledge of equipment validation processes, including IQ/OQ/PQ protocols, equipment lifecycle management, and regulatory requirements.
• Excellent technical writing skills, with the ability to create clear, thorough, and accurate validation documentation and reports.
• Strong problem-solving abilities and troubleshooting skills, with an analytical approach to equipment issues.
• Ability to manage multiple projects and priorities effectively in a fast-paced environment.
• Familiarity with regulatory standards such as 21 CFR Part 820, 21 CFR Part 11, and ISO 9001.
• Proficient in the use of validation tools and software to track equipment qualifications and validations.
• Excellent communication skills (written and verbal), with the ability to work collaboratively with cross-functional teams.
• Strong attention to detail and organizational skills.

Language Requirements: Proficiency in English (written and spoken).