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At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We’re focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. As a Validation Manager in Mt. Vernon, IN, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. Operations at AstraZeneca is a truly world-class business unit. It offers one of the most exciting, fast paced, challenging and rewarding work environments in the world of operations, supply chain and manufacturing.Global Operations is fundamental to our purpose of delivering life-changing medicines to patients, touching every aspect of our business and providing a platform for everything that we do. We harness the specialist talents of 13,000 people around the world – 20% of our global workforce. With 30 production facilities in 18 countries we’re focused on supplying our medicines with care, quality and efficiency, reducing the time from lab to patient. Keen to bridge the gap between science and patients? Turn research into reality? And forge a global career that’s full of possibilities, as part of a world-class team? Come and thrive in our vibrant, energizing, connected and supportive culture and make a real difference to patients.The Validation Manager is responsible for the site Master Validation Plan and ensures that qualification and validation systems are in compliance with regulatory guidelines and standards.Job Responsibilities:
Responsible for site Qualification and Validation Plans that include process validation, packaging validation, cleaning validation, equipment qualification, utilities and facilities qualification, and computer system validation.
Develops, implements, integrates, and sustains validation systems to enhance compliance in accordance with ICH guidelines Q8, Q9, and Q10.
Creates and implements changes in the qualification programs to enhance compliance, reduce costs, improve customer service, and strengthen technical base.
Collaborates with various engineering system owners such as formulation, packaging, and automation to reduce product cost and increase productivity while sustaining or improving the validated systems. Manages and controls validation documents.
Serves as a subject matter expert for equipment, process, packaging, computer system, and cleaning qualification and validation systems for site regulatory inspections.
Collaborates with PT&D during technical transfers to integrate process analytical technology (PAT) and system controls within the Quality by Design framework.
Develops and maintains effective relationships with internal and external customers, regulators, and other stakeholders.
Updates, reviews, and approves area procedures to ensure compliance with Good Manufacturing Practices.
Solves qualification and validation issues using critical analyses skills; develops sound, reasoned solutions and recommendations.
Evaluates new projects or existing equipment modifications, in terms of qualification and calibration needs, regarding the quality impact.
Manages the qualification activities associated with all Quality Investigations.
Makes effective financial and operational decisions to positively impact both short and long-term objectives.
Responsible for developing the Validation budget and managing related spend.
Ensures that cost improvement projects are completed to meet the site goals.
Qualifications:Education:
Bachelor’s degree required, preferably in Chemistry or Industrial Pharmacy.
Required:
Strong understanding of cGMPs, demonstrated leadership, management, and technical capabilities.
Demonstrated applied knowledge of ICH guidelines Q8, Q9, and Q10, statistical process control, and PAT.
Excellent verbal, written, and interpersonal communication skills are essential. Demonstrated ability to effectively communicate and collaborate across all levels of the organization including with customers, vendors, equipment suppliers, and operations staff.
Must have demonstrated ability to plan, implement, and achieve significant, complex goals and objectives.
Experience in conceptual development, project management (planning and scheduling projects), design, and implementation of major capital projects.
Knowledge and understanding of validation and qualification principles, project management, and change control principles.
Ability to understand and utilize financial analyses to make good decisions in a manufacturing environment.
Demonstrated ability to manage a multi-disciplined technical staff.
Desirable:
Master’s degree is highly desirable.
Six Sigma green belt or equivalent experience is preferred.
Experience with IQ/OQ/PQ and Lean Manufacturing is highly desirable.
Experience in the pharmaceutical industry and related regulatory, engineering, and construction techniques is highly desirable.
Next Steps – Apply today!To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.
