Share Email Opening Title Validation Engineer (Equipment) III  Category Validation   Description Why Join Societal CDMO? Mission and Culture: Each day we Bring Science to Society as we work towards improving the quality of life for patients who benefit from the therapies that we manufacture. We strongly believe that every employee plays an impactful role in accomplishing our mission of improving patients lives through client partnerships. Whether you are working hands-on developing, manufacturing, or, testing the products or if you are utilizing your expertise in any other way, through your work here you will have an opportunity to positively affect countless lives. We foster a culture that is diverse, inclusive, challenging,and supportive. At Societal, we are committed to continuous improvement both as individuals and as an organization and we encourage our employees to continue their personal and professional development in a variety of ways. Your New Role At Societal: We are looking for a Validation Equipment Engineer III.In this role, you will be responsible for providing a technically competent risk-based approach for the validation of manufacturing equipment, critical utilities, and facilities. Own the validation for equipment cleaning procedures, manufacturing processes, and computer systems. You will create, execute and approve validation protocols and reports. The position also requires the use of risk assessment tools for assessing validation requirements and the execution of periodic reviews where appropriate. This person will actively coordinate with Engineering, Product Development (PD), Manufacturing, Packaging, Regulatory Affairs, Quality Control and Quality Assurance to assure validation documentation is compliant with regulatory requirements and current industry practices. This position will be 80% remote and 20% on site when needed. This role is hybrid approximately 70% remote and 30% onsite. How You Will Make An Impact: Planning and execution of significant cross-functional validation projects in support of equipment, utilities, facilities, product, processes, computer systems and cleaning validation. (25%) Write and review protocols and reports. (25%) Perform and lead risk assessment exercises in support of validation activities and perform periodic reviews as needed. (15%) Collaborate with PD to ensure successful product development and technical transfer to Manufacturing. (10%) Coordinate validation activities including, but not limited to, protocol training, execution by validation and other departments, data collection, deviation resolution, and CAPA initiation, in support of assigned validation projects. (10%) Review and update validation SOPs. (5%) Maintain knowledge and comprehensive understanding of relevant pharmaceutical regulations and current interpretations affecting equipment, utilities, facilities, product, process, computer system, and cleaning validation. (5%) Validation representative on-site project team and resource to other departments for product and process knowledge. (5%)   Position Requirements Ideal Candidate Will Bring: Bachelor’s degree in an engineering or science field Minimum of four years of relevant experience in the pharmaceutical industry with a minimum of 3 years of validation experience. Consistently demonstrated validation proficiency with knowledge consistent of an SME in one or more of the areas of validation: equipment qualification, critical utilities and facilities qualification, cleaning validation, process validation, or computer/automation systems validation. Experienced in current validation trends and processes At Societal, we offer a diverse and competitive total rewards package to attract and retain talent.  In addition to base compensation, all employees are eligible for one of our annual performance opportunities (bonus or commission) and equity-based long-term incentive. In addition, we offer a wide range of benefits including medical, dental, vision, paid time off, paid company shutdowns and holidays, 401k matching, life insurance, paid parental leave and much more. Who is Societal: Societal is a bi-coastal contract development and manufacturing organization (CDMO) with expertise to deliver on our client’s needs, regardless of complexity level. These projects span pre-Investigational New Drug (IND) development to commercial manufacturing and packaging for a wide range of therapeutic dosage forms. We provide industry-leading support for small molecule therapeutic development, end-to-end regulatory support, clinical and commercial manufacturing, aseptic fill/finish, lyophilization, packaging, and logistics services to the global pharmaceutical market. We do all of this in our best-in-class facilities in San Diego, California, and Gainesville, GA. If you would like to apply for this position, please visit our website at www.societalcdmo.com and click on the "Careers" section. New hires will pass a background check, and drug screen and will be required to show proof of COVID vaccination (subject to limited qualified exemptions) as a condition of employment. We are an EOE dedicated to a diverse workforce and a Drug-Free work environment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other characteristic protected by law.   If you require accommodation to complete the application or interview process, please contact careers@societalcdmo.com.   About the Organization Societal is a bi-coastal contract development and manufacturing organization (CDMO) with expertise to deliver on our client's needs, regardless of complexity level. These projects span pre-Investigational New Drug (IND) development to commercial manufacturing and packaging for a wide range of therapeutic dosage forms. We provide industry leading support for small molecule therapeutic development, end-to-end regulatory support, clinical and commercial manufacturing, aseptic fill/finish, lyophilization, packaging and logistics services to the global pharmaceutical market. We do all of this in our best-in-class facilities in San Diego, California and Gainesville, Georgia. New hires will pass a background check and drug screen as a condition of employment.   EOE Statement We are an EOE dedicated to a diverse workforce and a Drug-Free work environment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other characteristic protected by law. If you require an accommodation to complete the application or interview process, please contact careers@societalcdmo.com.   EmpID None Specified  This position is currently not accepting applications. To search for an open position, please go to http://Societal.appone.com WE ALSO RECOMMEND Other Jobs Within Same Category -- None found -- Other Jobs Within 60 Miles -- None found --

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