Project Validation Engineer

• Provide direction, documentation, execution and review for project validation activities.

• Develop project validation documentation during the FEP process and throughout the lifecycle of projects.

• Responsible for the creation of validation packages and review of all validation protocols and packages related to assigned projects

• Ensure compliance with Abbott policies and procedures, adherence to quality and efficiency goals and departmental budget performance.

• Responsible for supporting plant capital projects as assigned.

• Support Snr Project Engineers with the development of project documentation. • Development and execution of validation protocols (FAT, DQ, IQ, OQ PQ).

• Execution of change controls.

• Management of any project associated Quality issues and CAPA’s.

• Work closely with Snr Project Engineers to ensure the work being undertaken is correctly documented in advance and the validation implications have been considered.

• Attend weekly Validation Review meetings with other engineers from around the site and the Quality/Validation Manager to ensure co-ordination of effort and minimising of unforeseen impacts.

• Liaise with internal engineering project co-ordination team, consultants, subcontractors, supervisors and the general workforce involved in the project to ensure full compliance with solution requirements.

• Responsible for the creation of validation packages and review of all validation protocols and packages related to assigned projects

• Utilise QA IT Systems (M-FILES) through which Validation Change Control is documented.

• Provide direction, documentation, execution and review for project validation activities.

• Develop project validation documentation during the FEP process and throughout the lifecycle of projects.

• Work closely with the Validation and Manufacturing Team.

• Work closely with project equipment vendors to obtain information to successfully specify requirements for plant and facility.

• Ensure compliance with Abbott policies and procedures, adherence to quality and efficiency goals and departmental budget performance.

• It is a requirement to have experience and knowledge on Validation and CAPA Policies or FDA regulations in relation to validation.

• Good Team Player

• Flexible with a can-do attitude

• Follow all Health and Safety Rules and Regulations in the plant

• Maintain plant safety at the highest level with a zero-accident target and with immediate response and thorough investigation and corrective action for all hazardous occurrences and accidents.

• It is important that GMP is a main priority in any operation carried out in this job function.

• Establish communication lines with all other departments e.g. Manufacturing, Q.A., Materials, Human Resources, Technical Operation Support and Finance.

• Plan and schedule work in accordance with plant demand and available manpower.

• Ensure compliance with Company International Global Standards, GMP & Environmental requirements.

• Responsible for promoting good employee relations.

• This job function will change where update procedures to GMP, EHS, Technical/New Equipment, Quality procedures and SOPs are made.

• Support Business Excellence initiatives in the plant.

• Bachelor’s Degree in Engineering or equivalent discipline.

• Minimum of 3 years relevant experience in Engineering.

• Knowledge of an Automated Manufacturing Environment (understanding of packing equipment a distinct advantage).

• Good mental ability to logically follow a line of though for problem solving. Accountability / Scope

• Considerable and continual care and attention is needed to avoid substantial damage to equipment.

• Continual attention needed to ensure plant reaches its annual production plan. • Failure on the incumbent part not to exercise due care could cause repeated small losses or occasional damage.

• Environmental non-compliance will result in EPA/Legal censorship.

Abbott