Validations Engineer

Description:

The Validations Engineer will primarily be accountable for the validation for Processes, Facilities, Equipment, Cleaning, Computer Software Validations (CSV) and IT projects, in both a Medical Device and Pharmaceutical (cGMP) environment, including the Site Validation Master Plan (SVMP) and maintenance of such plan.

RESPONSIBILITIES:

• Prepare and issue Site Validation Master Plans (SVMP), Summary Reports, and other required documentation for validation exercises, leading validation activities to ensure an effective validation service.
• Plan and schedule validation activities to meet customer and business needs in alignment with overall project objectives and timelines.
• Provide validation leadership to ensure that operations comply with regulatory and company requirements, offering support and advice to other departments as necessary.
• Oversee validation projects related to processes, facilities, equipment, cleaning, and CSV/IT validation, ensuring full compliance with regulatory and company standards.
• Provide specialist knowledge on validation processes, facilities, equipment, cleaning, and the use of computer software within production and service environments.

REQUIRED EXPERIENCE:

• Level 6 qualification within a regulated science industry or equivalent experience
• Minimum 5 years of validation experience in the Pharmaceutical/Medical Devices sector, including cleaning, analytical methods, lab equipment, computer system validation, and re-qualification
• Proficient in Minitab or similar system/software packages
• Manufacturing process validation experience preferable, including the validation of new processes and changes to established processes using the lifecycle approach to validation
• Knowledge of Quality Management Systems ISO14971
• Excellent communication skills
• Ability to take initiative within controlled working environment
• Ability to meet deadlines
• Attention to detail