BioSpace
Overview
The QA Validation Fill Finish team is hiring a Manager. As the Manager, QA Validation you will validate/qualify equipment, systems, and processes related to cleaning, sterilization, and Aseptic Process Validation in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures. Role highlights and responsibilities include leading validation efforts, mentoring staff, and ensuring compliance with quality systems. Responsibilities
Leads cross-functional teams in developing Validation best practices, standards and guidelines which include exploring new techniques, methods, and other industry practices. Leads projects by developing plans, schedules, resource loading and other project deliverables; executes validation projects and is responsible for validation projects as well as junior-level staff; authoring protocols, implementing validation protocols, and writing reports of validation results. Reviews and approves Validation protocols and summary reports; mentors Validation staff writing protocols and final reports. Prepares equipment for qualification studies and implements qualification and validation studies according to approved protocols and SOPs. Leads team of Validation specialists who investigate and troubleshoot problems and determine solutions or recommendations for changes and/or improvements. Approves various documents relating to area function. Provides direction and assigns work to Validation Specialists to meet goals and timings. Coordinates prioritization of activities with area management. Responsible for compliance monitoring of area operations, including trending of failures and evaluating efficiency of corrective actions. Reviews internal and external requirements and implements required processes, as needed, to meet expectations regarding Quality. Participates in regulatory and customer activities. Collaborates with functional departments to resolve issues. Leads projects and prepares status reports. Qualifications
To be considered for this role you must hold a Bachelor’s degree in Chemistry, Engineering, or Life Sciences and the following years of experience for each level: Associate Manager: 6+ years Manager: 7+ years May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role. Gowning and Environment: Full cleanroom attire and related requirements. Ability to remove jewelry, makeup, and nail adornments when wearing cleanroom attire. Salary Range (annually): $89,100.00 - $170,100.00 Seniority level
Mid-Senior level Employment type
Full-time Job function
Quality Assurance Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted.
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The QA Validation Fill Finish team is hiring a Manager. As the Manager, QA Validation you will validate/qualify equipment, systems, and processes related to cleaning, sterilization, and Aseptic Process Validation in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures. Role highlights and responsibilities include leading validation efforts, mentoring staff, and ensuring compliance with quality systems. Responsibilities
Leads cross-functional teams in developing Validation best practices, standards and guidelines which include exploring new techniques, methods, and other industry practices. Leads projects by developing plans, schedules, resource loading and other project deliverables; executes validation projects and is responsible for validation projects as well as junior-level staff; authoring protocols, implementing validation protocols, and writing reports of validation results. Reviews and approves Validation protocols and summary reports; mentors Validation staff writing protocols and final reports. Prepares equipment for qualification studies and implements qualification and validation studies according to approved protocols and SOPs. Leads team of Validation specialists who investigate and troubleshoot problems and determine solutions or recommendations for changes and/or improvements. Approves various documents relating to area function. Provides direction and assigns work to Validation Specialists to meet goals and timings. Coordinates prioritization of activities with area management. Responsible for compliance monitoring of area operations, including trending of failures and evaluating efficiency of corrective actions. Reviews internal and external requirements and implements required processes, as needed, to meet expectations regarding Quality. Participates in regulatory and customer activities. Collaborates with functional departments to resolve issues. Leads projects and prepares status reports. Qualifications
To be considered for this role you must hold a Bachelor’s degree in Chemistry, Engineering, or Life Sciences and the following years of experience for each level: Associate Manager: 6+ years Manager: 7+ years May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role. Gowning and Environment: Full cleanroom attire and related requirements. Ability to remove jewelry, makeup, and nail adornments when wearing cleanroom attire. Salary Range (annually): $89,100.00 - $170,100.00 Seniority level
Mid-Senior level Employment type
Full-time Job function
Quality Assurance Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted.
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