Manager, MSAT Process Validation Engineer

Company: GlaxoSmithKline
Location: Cambridge
Posted on: May 24, 2023

Job Description:

Site Name: Cambridge Binney StreetPosted Date: Mar 31 2023GSK is currently looking for a Manager, MSAT Process Validation Engineer for our Manufacturing Science and Technology (MSAT) department to join our team in Cambridge, MA.In this newly created role, you will be responsible for the execution of Process Validation (PV) activities. You will be providing support to routine process validation studies, assisting with new product technology transfers or lifecycle management changes, and audit support. We're looking for a motivated individual with demonstrated aptitude for learning new systems and software, performing data analysis, and applying statistical methods, learning new manufacturing processes. Ability to communicate effectively across multiple platforms/mediums and skill with technical writing is essential.Key responsibilities

• Provide leadership and technical support for the validation group.
  • Draft, coordinate and execute validation protocols, perform data analysis and author process validation reports with consistent and effective communication with other functions.
  • Author and perform the technical review of deviations, change controls, perform process monitoring (manufacturing data summary and analysis, data presentation), perform activities for lot release (assess deviations and process changes).
  • Perform risk assessment and mitigation steps to achieve validation requirements and ensure each process remains in a validated state of compliance by compiling and analyzing data for continued process verification.
    • Work closely with other validation department personnel and cross-functionally with MSAT, Manufacturing, Engineering, QA, QC, Regulatory and project management to achieve all project deliverables.
    • Participate in implementation of Process Validation policies and procedures.
    • Provide leadership and technical decision-making regarding cGMP compliance, regulatory questions, validation strategy, and quality systems.
    • Support Associated Director Process Validation by interacting with regulatory authorities during Site inspections; supports successful management of inspections.Why you?Basic Qualifications:
      • Bachelor of Science Degree in Chemical Engineering, Biotechnology, Biochemistry or equivalent related discipline
      • 8+ years of industry-related experience (Process Validation, QA, QC, manufacturing) and minimum of 4+ years of hands-on process validation experience.Preferred Qualifications:
        • Basic knowledge of statistical software is preferred
          • Solid organization, problem-solving, decision-making, judgment, leadership, and team-oriented skills are essential to manage multiple projects of variable complexity.
          • Solid interpersonal skills are required in order to effectively communicate with all levels of the organization in various functional areas.
          • Microsoft-' Word, Excel and Project experience required.
          • Possess strong knowledge of Process Performance Qualification /Validation practices, including applicable regulations.
          • Experience with commercial manufacturing and cGMPs regulations.Why GSK?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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. 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.#GSKBinneyStreet #GSKAffinivax#LI-GSK#WYACommercial2022GSK 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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.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/ AgenciesGSK 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 site.

Keywords: GlaxoSmithKline, Cambridge , Manager, MSAT Process Validation Engineer, Engineering , Cambridge, Massachusetts