Validation Supervisor - GlaxoSmithKline LLC
GlaxoSmithKline
Posted Saturday, April 20, 2024
Posting ID: 394707
King of Prussia, PA
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Site Name: USA - Pennsylvania - King of Prussia
Posted Date: Apr 19 2024
Job Title Validation Supervisor - GlaxoSmithKline LLC
Details Responsible for the self-directed supervision of the day-to-day operations of Validation team members to support the value stream. Lead their team as a front-line leader (hands-on, on the floor, management). Assign day-to-day validation tasks, set objectives, and define professional development plans for team members. Develop and improve validation procedures, practices, and policies. Develop team to become proficient in validation activities (e.g., equipment qualification and cleaning validation).Set priorities, fulfill customer needs, define timelines, and track projects supporting the value stream. Ensure team deliverables are met within defined timelines. Oversee the development of required validation studies and protocols for facilities and equipment and lead the effort to approve protocols and associated reports. Support deviation investigations and remedial actions as required, managing the implementation of quality and safety continuous improvements. Interface with other departments to coordinate resources and complete validation activities in a timely manner. Development of Validation Project Plans to support major changes to the site for new product introduction and technology transfers. Oversee the implementation of validation activities for all manufacturing equipment within GSK's 2000L value stream to enable clinical and commercial manufacture of multiple products to be introduced rapidly and manufactured efficiently with quick changeovers. Review of new and modified systems to ensure designs comply with current validation standards and systems are able to be adequately validated. Propose strategies and priorities in planning technical transfer/process validation activities within area of expertise. Establish the cleaning validation strategy for all new products coming into the 2000L value stream including establishing the guidance for cleaning validation of a multi-product facility, scoping the worst-case conditions for the existing and expected products, defining the plan for validating those worst-case conditions, and designing the assessment for new products to compare to the existing validated state.
Basic Qualifications: Must have a Bachelor's degree (or foreign equivalent) in Biochemical Engineering, Biology or related field, and 5 years of progressive validation experience along with the following:
•3 years of experience in people or matrix leadership consisting of peers, subordinates, or senior personnel in multidisciplinary teams involving scientific, engineering, and operational disciplines;
•3 years of experience utilizing current GMP's, NIH Guidelines and FDA or European validation practices for biopharmaceutical processes and supporting regulatory audits as SME;
•2 years of experience in the validation of large-scale bulk biopharmaceutical facilities including cell culture, or microbial fermentation, or protein recovery and purification operations including hands-on experience with single-use systems used in biopharmaceutical processes; and
•2 years of experience in utilizing industry and validation practices related to technology transfer and product lifecycle including executing technology transfer plans.
Location: 709 Swedeland Road, King of Prussia, PA 19406
Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.
Posted Date: Apr 19 2024
Job Title Validation Supervisor - GlaxoSmithKline LLC
Details Responsible for the self-directed supervision of the day-to-day operations of Validation team members to support the value stream. Lead their team as a front-line leader (hands-on, on the floor, management). Assign day-to-day validation tasks, set objectives, and define professional development plans for team members. Develop and improve validation procedures, practices, and policies. Develop team to become proficient in validation activities (e.g., equipment qualification and cleaning validation).Set priorities, fulfill customer needs, define timelines, and track projects supporting the value stream. Ensure team deliverables are met within defined timelines. Oversee the development of required validation studies and protocols for facilities and equipment and lead the effort to approve protocols and associated reports. Support deviation investigations and remedial actions as required, managing the implementation of quality and safety continuous improvements. Interface with other departments to coordinate resources and complete validation activities in a timely manner. Development of Validation Project Plans to support major changes to the site for new product introduction and technology transfers. Oversee the implementation of validation activities for all manufacturing equipment within GSK's 2000L value stream to enable clinical and commercial manufacture of multiple products to be introduced rapidly and manufactured efficiently with quick changeovers. Review of new and modified systems to ensure designs comply with current validation standards and systems are able to be adequately validated. Propose strategies and priorities in planning technical transfer/process validation activities within area of expertise. Establish the cleaning validation strategy for all new products coming into the 2000L value stream including establishing the guidance for cleaning validation of a multi-product facility, scoping the worst-case conditions for the existing and expected products, defining the plan for validating those worst-case conditions, and designing the assessment for new products to compare to the existing validated state.
Basic Qualifications: Must have a Bachelor's degree (or foreign equivalent) in Biochemical Engineering, Biology or related field, and 5 years of progressive validation experience along with the following:
•3 years of experience in people or matrix leadership consisting of peers, subordinates, or senior personnel in multidisciplinary teams involving scientific, engineering, and operational disciplines;
•3 years of experience utilizing current GMP's, NIH Guidelines and FDA or European validation practices for biopharmaceutical processes and supporting regulatory audits as SME;
•2 years of experience in the validation of large-scale bulk biopharmaceutical facilities including cell culture, or microbial fermentation, or protein recovery and purification operations including hands-on experience with single-use systems used in biopharmaceutical processes; and
•2 years of experience in utilizing industry and validation practices related to technology transfer and product lifecycle including executing technology transfer plans.
Location: 709 Swedeland Road, King of Prussia, PA 19406
Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.
Contact Information
Email: at-jobfeeds+glaxosmithkline@careercircle.com
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
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