Ireland Compounding Validation Lead

at  Baxter

THIS IS WHERE YOU SAVE AND SUSTAIN LIVES

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

KNOWLEDGE & SKILLS

• Cleanroom / aseptic manufacturing practical work
• Technical understanding of cleanroom plant and associated equipment inclusive of validation and requalification
• Good people, communication and computer literacy skills.
• Experience of operating within maintenance and project engineering functions.
• Knowledge and experience of implementation of continuous improvement activities.
• Knowledge and experience of implementation of engineering standard methodology
• Experience in 6-Sigma and Lean Manufacturing.

“What are some of our benefits of working at Baxter?

• Pension
• Annual Bonus
• Health Insurance
• Life Assurance
• Baxter is committed to growing and developing an inclusive and diverse workforce – you can read more about our specific values here https://www.baxter.com/careers/inclusion-diversity.

YOUR ROLE AT BAXTER:

The role of the Validation Lead is to conduct, coordinate and manage project related validation activity in order that validation documentation is prepared to the necessary standards and implemented in line with the overall Project Validation Master Plan for Ireland Compounding in our South Dublin Sites.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Lead Qualification and Validation tasks, to ensure new equipment and processes are operational on time and existing equipment and processes remain in a validated state.
• Preparation of validation documents / protocols (VMP’s, URS, RTM, DQ, IQ, OQ & PQ)!
• Execution of Validation activities (IQ, OQ, PQ, PQ)!
• Adhere strictly to regulatory, cGMP, Standard Operating Procedures, Policies & any other rules defined by the Company.
• Deviation / Non- Conformance management (Including RA, RCA & CA/PA).
• Change Control Management.
• Strong Validation and install experience in relation to Facilities and Utilities in a Pharmaceutical, Medical Device or similar environment.
• Find opportunities and propose justified solutions for productivity & Quality improvements, including streamlining of processes and the use of IT-systems; and to manage their implementation.
• Support Validation responsible to maintain and report on the suite of relevant Metrics and Key indicators.
• Participating in and contributing to Baxter team projects and initiatives as required.
• Ensuring validation documents are in a constant state of “audit readiness”.
• Project management and execution of Capital Expenditure and Process Improvement Projects for EMEA Validation project portfolio