Azzur Group
CQV -Sterilization
Azzur Group - Phila, Pennsylvania, United States, 19117
Work at Azzur Group
Overview
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Overview
Azzur Group is seeking a highly skilled CQV - Sterilization professional to join our talented team. This role is essential for ensuring the compliance and validation of sterilization processes within our pharmaceutical facilities, ensuring that they meet all regulatory requirements and industry standards. The CQV - Sterilization specialist is responsible for overseeing the qualification and validation of sterilization equipment and processes, as well as conducting risk assessments and documentation related to sterilization activities.
KEY RESPONSIBILITIES:
Lead the qualification and validation efforts for sterilization processes including steam, ethylene oxide, and other methods as necessary. Develop and execute validation protocols, reports, and documentation in compliance with regulatory and internal quality standards. Conduct risk assessments on sterilization processes and implement mitigation strategies. Ensure proper documentation and compliance with cGMP standards. Collaborate with cross-functional teams to ensure seamless integration of sterilization processes within the product lifecycle. Participate in investigations and corrective action plans related to sterilization deviations. Maintain up-to-date knowledge of industry trends, regulatory changes, and new sterilization technologies. Train and mentor junior staff on sterilization validation methodologies. Promote a culture of quality and compliance in all sterilization activities. Requirements
QUALIFICATIONS AND REQUIREMENTS:
Bachelor's Degree in Engineering, Life Sciences, or related field. 5+ years of experience in validation within the pharmaceutical or biotechnology industries, with a specific focus on sterilization processes. Strong understanding of validation principles and regulatory guidelines, including FDA, EU, ISO, and cGMP. Experience with sterilization technologies such as steam, ethylene oxide, and radiation. Ability to interpret scientific data, write technical reports, and develop robust validation protocols. Proficient in utilizing statistical and analytical tools for data evaluation. Strong communication and collaboration skills to work effectively in cross-functional teams. Detail-oriented with a strong commitment to delivering high-quality results. Azzur Group is an equal opportunity employer and values diversity in our workforce. We encourage all qualified applicants to apply, regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.
Benefits
Azzur Group is an equal opportunity employer and promotes a diverse culture in our workplace. We believe that promoting diversity plays an important role in developing top-quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.
Health Care Plan (Medical, Dental & Vision) Retirement Plan (401k) Life Insurance (Basic, Voluntary & AD&D) Paid Time Off (Vacation, Sick & Public Holidays)
KEY RESPONSIBILITIES:
Lead the qualification and validation efforts for sterilization processes including steam, ethylene oxide, and other methods as necessary. Develop and execute validation protocols, reports, and documentation in compliance with regulatory and internal quality standards. Conduct risk assessments on sterilization processes and implement mitigation strategies. Ensure proper documentation and compliance with cGMP standards. Collaborate with cross-functional teams to ensure seamless integration of sterilization processes within the product lifecycle. Participate in investigations and corrective action plans related to sterilization deviations. Maintain up-to-date knowledge of industry trends, regulatory changes, and new sterilization technologies. Train and mentor junior staff on sterilization validation methodologies. Promote a culture of quality and compliance in all sterilization activities. Requirements
QUALIFICATIONS AND REQUIREMENTS:
Bachelor's Degree in Engineering, Life Sciences, or related field. 5+ years of experience in validation within the pharmaceutical or biotechnology industries, with a specific focus on sterilization processes. Strong understanding of validation principles and regulatory guidelines, including FDA, EU, ISO, and cGMP. Experience with sterilization technologies such as steam, ethylene oxide, and radiation. Ability to interpret scientific data, write technical reports, and develop robust validation protocols. Proficient in utilizing statistical and analytical tools for data evaluation. Strong communication and collaboration skills to work effectively in cross-functional teams. Detail-oriented with a strong commitment to delivering high-quality results. Azzur Group is an equal opportunity employer and values diversity in our workforce. We encourage all qualified applicants to apply, regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.
Benefits
Azzur Group is an equal opportunity employer and promotes a diverse culture in our workplace. We believe that promoting diversity plays an important role in developing top-quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.
Health Care Plan (Medical, Dental & Vision) Retirement Plan (401k) Life Insurance (Basic, Voluntary & AD&D) Paid Time Off (Vacation, Sick & Public Holidays)