Validation Specialist

Description

Team Horizon is seeking an experienced Validation Engineer for the role of Pharmaceutical Technology Specialist for our Client who are based in Co. Mayo.

The successful candidate will be part of the Validation Department who are responsible for the qualification / validation of all CGMP equipment, systems and processes. The role of the Pharmaceutical Technology Specialist is to ensure customer satisfaction is delivered with each, revalidation, validation, and project work.

Why you should apply:

This is an excellent opportunity to join a company who are Recognised as a Great Place to Work in Ireland, and have a solid employee-focused foundation

What you will be doing:

Over-see, coordinate, guide and implement the site validation master plan under prospective, concurrent and retrospective validation studies in a timely manner, with the relevant engineers
Ordering parts and equipment
Ensure that all validation requirements are met for any new process, equipment or change to existing processes or equipment.
Actively work on validation projects, being the departmental point person, and completing all associated project documentation in line with current corporate and regulatory expectations.
Ensure that all documentation pertaining to each validation study under his/her responsibility is compiled, authorised and filed in a timely and organised fashion.
Work with the other validation engineers to achieve compliance by co-ordinating each validation project assigned. The process involves the review and approval of validation documentation and co-ordination of the validation work.
Facilitate the PQR review process / Regulatory Review Process and Laboratory Equipment Review Process as per the current rota.
Keep ahead 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 EHS within the department.
Achieve the companies stated quality objectives through continuous improvement efforts and conformance to quality standards.
Attend Departmental and APEX meetings and actively participate in any Quality or Safety initiatives on site.

What you need to apply:

Relevant 3rd Level Qualification is essential.
Experience in Pharmaceuticals Manufacturing/Production is essential.
Demonstrate exceptional project management skills is essential. Proficient in use of Microsoft Office suite of programs is essential.
Experience with Validations processes is essential. Excellent communication, organization, time-management, and teamwork skills.
Demonstrate ability to work on one’s own initiative with a passion for results. 
Ability to articulate clearly when dealing with colleagues, peer groups and managers.
Ability to plan and schedule workload. 
Ability to work well under pressure and consistently deliver results while demonstrating an action- orientated approach to overcome obstacles.
There may be occasional shift work involved.

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