Sr Validation Engineer
The Senior Validation Engineer will be directly responsible for the creation of Validation Strategy; preparation and execution of Installation Qualifications, Operational Qualifications, Performance Qualifications, Process Validation and Cleaning Validation which are harmonized with this division's corporate standards.
This position will be responsible for the development and execution of the requalification plan for the site.
This position will also be required to contribute to the development of Site Validation Master Plans, cleaning validation master plans and computer validation master plans. This position will implement and maintain computer systems in compliance with regulatory and company requirements and administer the Computer Validation Program at the Marietta facility.
• Support all aspects of the Validation Life Cycle in Manufacturing from design through operation and improvement as required. Creates new validation approaches for new equipment; processes, or to align procedures and standards.
• Administer and create the Computer Validation Program for the site, including the author/review/approval of Computer Validation Master Plans, Process Control Installation/Operational Qualification protocols, and alarm acceptance testing protocols, computer acceptance protocols and maintenance of computer systems in accordance with corporate and departmental procedures.
• Provide key technical review for the Marietta Site with respect to SOP development and provide technical input for change control in order to assure that site needs are addressed and compliance and industry standards are incorporated.
• , review or revise Standard Operating Procedures (SOP's) as required.
• Responsible for developing the site requalification plan and strategy, execution and implementation. Streamline testing requirements while maintaining regulatory and corporate compliance.
• Responsible for the preparation of site validation documentation such as qualification protocols, validation master plans, risk assessments, periodic reviews.
• Maintain up to date knowledge of validation requirements, practices, and procedures and instruct other members of the site participating in validation studies.
• Participate on cross-functional teams, including value streams and site support groups to address specific problems, facilitate discussion and research and enable procedures to become more efficient. Build and enhance interdepartmental relationships. Implement improvement initiatives with filling/packaging and facility/utility qualification activities.
• As the site validation representative, present information or answer questions to regulatory agencies during the audit process regarding the validation program and specific validation studies.
• Perform all job responsibilities in compliance with applicable EHS and GMP regulations, guidelines, policies, and standard operating procedures.
• BS/BA required. Candidates with 8 years of related experience may be considered in lieu of a degree.
• 5 years pharmaceutical experience in validation preferably with knowledge of secondary process equipment .
• 5 years of Computer Systems Validation experience with a focus on controls
• Prior experience interfacing with regulatory agencies, as well as exposure to the regulatory submission process.
• Prior experience preparing and executing equipment qualification documents (IQ/OQ/PQ) .
• SME experience in any 3 of the following areas is required:
o Process Validation
o Cleaning Validation
o Equipment Qualification
o Sterilization Validation
o Validation of Aseptic Processing
o Packaging Equipment Qualification
o Computer Systems Validation
o Automation Qualification
o HVAC, Smoke Studies and EM Qualification
o Clean Utility Qualification
o AVI Qualification
BS/BA in science, chemical engineering or life sciences
We are a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. Our Vaccines business has a broad portfolio and innovative pipeline of vaccines to protect people of all ages. On average, each batch of vaccine will have undergone more than 100 quality checks before it is sent out, to ensure the vaccines meet world-class standards. We deliver over two million vaccine doses per day to people living in over 160 countries and are committed to continuously investing in our manufacturing facilities, improving our processes and building partnerships to ensure we meet the global growing needs for high quality vaccines.
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