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 Sr. Validation Engineer in Mt. Vernon, IN you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives.
As the Sr. Validation Engineer, you will perform installation and operational and performance qualification (IQ/OQ/PQ) of critical manufacturing equipment, facilities, and utility systems for the site. The Senior Validation Engineer provides technical support for process manufacturing and packaging including investigations and correction of cleaning process-related problems and deviations from standards. This position also performs cleaning validation for new and existing products.
• Performs installation and operational and performance qualification (IQ/OQ/PQ) of critical manufacturing equipment, facilities, and utility systems. Responsibilities include newly installed equipment and systems, as well as previously qualified equipment and systems, which are modified through Change Control and periodic assessments of equipment, facilities, and utility systems.
• Develops and reviews qualification protocols and reports, coordinates system and equipment documentation collection, and executes protocols.
• Develops and reviews cleaning validation protocols and reports, coordinates room and equipment documentation collection, and executes protocols.
• Solves qualification and cleaning validation execution issues using critical analysis skills and develops sound, reasoned solutions and recommendations.
• Works with Operating Technicians and Maintenance during fieldwork and execution of protocols.
• Oversees capital qualification services related to processing and/or packaging and performs peer review of contract/consulting documentation.
• Performs fieldwork such as checking systems and equipment that are located in manufacturing areas, on mezzanines and rooftops, and in mechanical spaces or penthouses.
• Represents the Validation group in Change Control Committee meetings and in Departmental qualifications and cleaning validation discussions.
• Verifies red-line drawings to "as-built" status.
• Performs assessments to determine if re-qualification and/or re-validation is needed in accordance with local procedures.
• Maintains and enhances reliable and responsive working relationships with internal and external customers and suppliers.
• Participates in the validation activities associated with all Quality Investigations.
• Participates in internal and external audits; able to defend own and others protocols and reports.
• Supports the Validation Manager in managing the Site Validation Master Plan and Master Schedule including all aspects of design qualification, verification, installation qualification, operational qualification, performance qualification, process validation, and cleaning validation for processing, packaging, equipment, computer systems, critical utilities, and equipment cleaning.
• Achieves effective financial control through the following: management of validation scopes, estimates, effective use of financial and budgeting tools, risk management, and proper project close-outs.
• Supports internal, external, and regulatory inspections including FDA, EMEA, and third party inspections to provide information for Validation.
• Participates in organizational teams to promote continuous quality improvement.
• Executes work in compliance with cGMPs, site policies, work instructions, and procedures.
• Works in partnership with site SHE to ensure qualification work is in compliance with environmental and safety regulatory standards.
• Maintains a safe work environment and follows site SHE policies and procedures.
• Bachelor's degree required, preferably in Engineering, Chemistry, Biology, or Pharmaceutical Sciences.
• At least 5 years of relevant validation experience in the pharmaceutical industry. A combination of education and relevant experience will be considered.
• Experience in conceptual development, project management (planning and scheduling projects), design, and implementation of major capital projects.
• Experience in the pharmaceutical industry and related regulatory, engineering, and construction techniques is highly desirable.
• Knowledge and understanding of validation and qualification principles, project management, and change control principles.
• A solid base and application experience in pharmaceutical manufacturing plants and/or research facilities, and/or related environmental projects, material handling, containment, and utility/infrastructure support facilities.
• Demonstrated ability to effectively communicate and collaborate across all levels of the organization including with customers, vendors, equipment suppliers, and Operations staff.
• General knowledge of basic electrical codes, safety guarding, and labeling.
• Experience with IQ/OQ/PQ, Cleaning Validation, and Lean Manufacturing is highly desirable.
• Six Sigma certification is preferred.
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.
A little about us:
MedImmune is the global biologics research and development arm of AstraZeneca