Validations Engineer

AbbVie

Westport, Co Mayo
Contract
Full-time

23 days ago

Company DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on , , , and .Job DescriptionWe currently require a Validations Engineer for the role of Pharmaceutical Technology Specialist to join our diverse Validations Team at AbbVie, Westport Co. Mayo, on a fixed-term contract basis.The Validation Department is responsible for the qualification / validation of all CGMP equipment, systems and processes utilized for routine operation at the AbbVie Westport manufacturing site. The Department is also responsible for the revalidation of critical systems & processes. Ideally you will have steam sterilisation, equipment validation experience, Process Performance Qualification experience.The role of the Validation Engineer/Pharm Tech Specialist is to 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 MOH regulatory requirements. This schedule compliance will be achieved by actively engaging with senior management and the impacted Business Unit's and ensuring all projects can be managed and prioritized as required.PLEASE NOTE: This role will be for a fixed term only with hours mainly being based on day shift on-site in Westport. However there may be requirements from time to time to travel off-site and flexibility around alternative shifts is desirable.So, are you ready to join the AbbVie team? Then read on...In your new role you will:

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
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.

QualificationsSo, what education & experience do you need for this role?

Relevant 3rd Level Qualification (Level 8 - Science/Engineering disciplines) 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.
Excellent oral, written, and presentation skills.
Excellent attention to detail.
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.

So, does this all sound like the right role for you? Then join AbbVie!Additional InformationAbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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