Validation Engineer

Team Horizon is seeking a Senior Validation Engineers our client’s facility. In this role, you will be responsible for delivering on the qualification and validation program, which will include planning and execution of validation/requalification activities on critical equipment.

Why you should apply:

• Join a fast paced and diverse team, in a company who are committed to  discovering, developing, & manufacturing innovative human therapeutics

• Flexibility around remote working when the role allows

What you will be doing:
 

• In this role, you will be responsible for delivering on the qualification and validation program which will include planning and execution of validation/requalification activities on critical equipment.

• Provide technical validation support to meet site objectives, comprising the full validation lifecycle process.

• Develop, review, and approve validation plans, protocols, and discrepancy summary reports.
  Lead the execution of airflow visualization, filter integrity, velocity, and particle monitoring testing activities

• Lead the execution of cycle development, performance qualifications, and requalification programs for VPHP isolators.
   
• Collate and report relevant validation data and metrics.

• Assist in the development and improvement of the validation lifecycle process while ensuring compliance with all applicable regulations and standards.

• Provide validation support for quality management system, including change control, deviation, and CAPA processes.

• Coordinate projects and prioritize workload in line with site priorities.

• Participate in multidisciplinary site and multisite teams, such as cross-functional investigation teams and change control

• Update and maintain validation Standard Operating Procedures (SOPs) in accordance with site and corporate requirements.
   
• Attend and contribute to staff meetings and training sessions as required.

• Comply with the responsibilities outlined in the Site Safety Statement and champion safe working practices.

• Perform all tasks with due care and attention in accordance with Good Manufacturing Practices and  requirements, policies, and procedures.

• Bachelor of Science/Engineering degree or equivalent.

• Knowledge of cGMPs and other worldwide regulatory requirements.

• Problem-solving ability and excellent oral and written communication skills

• 5+ years’ experience in a similar role. 

• Experience qualifying HVAC systems and/or executing VPHP qualifications.

• Familiarity with Quality and Document Management Systems, including Trackwise Deviations, CAPA and Change Controls, Maximo, CDOCs, Kneat.

• Independent, self-motivated, proactive, organized, able to multi-task in project environments, and skilled in communication and collaboration.

• Team player, prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.

Candidate must be eligible to work in the EU