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Welcome to AbbVie!
At AbbVie, we offer you the resources and a global reach to empower your innovative mindset. From day one, we’ve known it takes teamwork and collaboration to develop the scientific breakthroughs, innovative pipelines, and therapies that change millions of patients’ lives around the world. In short, we know it takes “you” to make those ground-breaking advancements happen. We take pride in serving and supporting our communities and protecting the environment, making a lasting impact that's felt within healthcare and beyond.
We are now recruiting a high 2 caliber Pharmaceutical Technology Specialist III (Validations Engineers) on a fixed term contract basis, to join our high performing Validations team in Westport, Co. Mayo. As part of this high performing team you will be responsible for the qualification/validation of all cGMP equipment, systems and processes utilized for routine operation within our AbbVie Westport manufacturing site. You will also be responsible for the revalidation of critical systems and processes.
In this role you will ensure customer satisfaction is delivered with each, revalidation, validation and project work. All revalidation or 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 BU’s and ensuring all projects can be managed and prioritized as required. A list of key duties and responsibilities are listed in more detail in the subsequent sections
Are you intrigued? Do you want to learn more?
A snapshot of your key responsibilities as Pharmaceutical Technology Specialist would be:
• Over-see and manage the revalidation schedule for the area assigned and ensure execution of the required activities within the required timeframe ensuring all revalidation requirements are met
• Monitoring, coordinating, guiding and implementing the site validation master plan under prospective, concurrent and retrospective validation studies in a timely manner, with the relevant engineers
• Ensuring 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
• To ensure that all documentation pertaining to each validation study under your responsibility is compiled, authorised and filed in a timely and organised fashion.
• To 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
• To facilitate the PQR review process / Regulatory Review Process and Laboratory Equipment Review Process as per the current rotas
• Keep abreast of current and changing regulatory guidance’s 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 participation in any Quality and Safety Initiatives
To succeed in this role, you will have the following Education and Experience:
• Bachelor’s degree required in science based or engineering discipline required
• Experience in Pharmaceutical company minimum 3 years ideally
• Excellent project management skills
• Proficient in use of Microsoft Office suite of programs
• Ability to think strategically and enterprise wide to ensure compliance and business needs are met or exceeded.
• Strong decision making skills.
• Negotiation skills, effective collaboration and ability to anticipate needs and requirements.
So, does this all sound like the right role for you? Then join AbbVie!
As an Equal Employment Opportunity Employer; we value bringing together individuals from diverse backgrounds to develop innovative solutions for patients and being part of an inclusive work environment.