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Sr. Validation Manager

Company: BAXTER
Location: Hickory
Posted on: November 23, 2022

Job Description:

--- 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. This role has overall responsibility to identify and implement technical improvement strategies that benefit compliance, quality, service and cost across the site product range. Ensures compliance with all cGMP regulations. Job Responsibilities Identify and manage, directly and with oversight, manufacturing process improvements that optimize compliance, quality, service and cost. Develop and manage the site validation master plan covering manufacturing process, equipment, room and equipment cleaning. Work with the Site Manager and the QMR to establish processes that deliver efficiency and consistency. Prepare technical documentation supporting change control and regulatory submissions. Provide routine process trending support to identify critical process parameter trends and respond accordingly. Utilize and promote Lean manufacturing methodology to work flows. Participate as requested in major investigation/reliability situations. Technically manage suppliers where necessary. Participate as needed in developing network alignment strategies. Ensure programs are designed to achieve first time approvals from the FDA, other regulatory agencies, PAI and general cGMP. Manage the technical interfaces with the FDA. Maintain master project activity timelines and progress charts. Prepare and report routinely key quality indicators and other critical activities. Facilitate site visits, training requirements and technical input. Communicate and resolve issues as needed. Coordinate with Human Resources recruitment, training and organizational programs to establish and maintain the necessary skill base. Sustain a clean and safe work area using 6S principles Learn, understand and apply rigorous quality standards, Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP) Knowledge, Skill and Abilities Must have a broad base of experience in manufacturing processes and equipment, a solid understanding of cGMP---s and validation processes, process automation and control. Knowledge of current industry validation strategies. Understanding and commitment to Lean/Six sigma strategies. Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words and drawings. Must have basic English written and oral communication skills adequate to communicate with other team members. Required Education and Experience BS/BA in Science or Engineering. PhD a plus. 10 or more years of progressively responsible experience in the pharmaceutical industry. Prior experience supervising, leading and directing groups with diverse technology and business backgrounds. Experience with process remediation a plus. Other Duties as Assigned Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. Overtime is worked as required. LI-LF1 IND-USOPS The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law. Equal Employment Opportunity Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. EEO is the Law EEO is the law - Poster Supplement Pay Transparency Policy Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Recruitment Fraud Notice Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice . 080223

Keywords: BAXTER, Hickory , Sr. Validation Manager, Executive , Hickory, North Carolina

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