Job Description

Team Horizon is seeking a Lab Validation engineer for our client based in Mayo. The QC Pharma Department is responsible for the qualification / validation of laboratory equipment, systems and processes utilized for routine operation Laboratories. The Department is also responsible for the revalidation of critical systems.

The role of the Validation Engineer is the ensure customer satisfaction is delivered with each revalidation, validation and project work. All validation activity is to be performed in line with Global Standards, FDA, HPRA and other MPH regulatory requirements. This schedule compliance will be achieved by actively engaging with senior management and the impacted BU’s and ensuring all projects can be managed and prioritized as required.

Why you should apply:

* This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.

* There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.

* Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally.

What you will be doing:

* Over-see, coordinate, guide and implement the site validation master under prospective, concurrent, and retrospective validation studies in a timely manner, with the relevant engineers.

* To ensure that all validation requirements are met for any new process, equipment or change to existing process or equipment.

* To actively work on validation projects, being the departmental point person and completing all associated project documentation in line with current corporate and regulatory expectations.

* To ensure that all documentation pertaining to each validation study under his / her responsibility is compiled, authorized and filed in a timely and organized fashion.

* To work with the other validation engineers to achieve compliance by coordinating each validation project assigned.

* The process involves the review and approval of validation documentation and co-ordination of the validation work

* Participate in risk assessment process for all business units & participate in design review process for all business units.

* Tracking and generation of weekly metrics (GTW QMS, EHS, Compliance Wire etc.)

* To facilitate the PQR review process / Regulatory Review Process and Laboratory Equipment Review Process as per the current rota’s.

* Keep abreast of current and changing regulatory guidance for the relevant areas of validation that applies. Provide support for audit preparation, direct audit interaction and involvement in audit response.

* Support and comply with internal EHS requirements, procedures and policies.

* Ensure continued conformance to the EMS within the department.

* Achieve the companies stated quality objective through continuous improvement efforts and conformance to quality standards.

* Attend department and APEX meetings and participation in Quality and Safety initiatives.

* Provide support for audit preparation, direct audit interaction and involvement in audit response. Participation in site internal and external audit program (to include periodic review).

What you need to apply:

* Bachelor’s degree required in science based or engineering discipline

* At least 2 years experience in Pharmaceutical company

* Excellent project management skills

* Proficient in use of Microsoft Office suite of programs

* Critical thinking and problem-solving skills

* Ability to articulate clearly when dealing with internal and external bodies.

* Excellent conflict handling skills

* Expertise in the relevant subject matter areas – example Equipment, Facility, Aseptics, Process, CPV, CSV, Cleaning