May 20, 2024

Process Engineer

  • GlaxoSmithKline
  • Cambridge, MA, USA
Full-Time Manufacturing

Job Description

Site Name: Cambridge Binney Street
Posted Date: Mar 19 2024

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.

GSK has an exciting new opportunity for an experienced Process Engineer who will work closely with Manufacturing senior leadership to achieve department goals, interdepartmental manufacturing readiness, and batch release requirements. The Process Engineer is also responsible for owning and driving manufacturing improvement projects from concept to completion, with a particular focus on creating efficiencies that contribute to safety, quality, cost, on-time delivery, and right first-time performance. The Process Engineer supports by working cross-functionally with internal support departments and occasionally with external manufacturing to drive project completion.

Key Responsibilities:
  • Work independently to drive/own and cross functional team performance.
  • Develop a strong understanding of the manufacturing process and details of the associated hands-on operating requirements.
  • Learn complex concepts and communicate the information in a way that is engaging and understood by users.
  • Collaborate closely with SMEs and QA teams to create clear, concise, and technically accurate documentation.
  • Perform all tasks associated with Quality Record Management and Initiation and collaboratively resolve issues.
  • Own and manage Manufacturing process specific change controls, and CAPA’s.
  • Author Minor and Major Deviation Investigations.
  • In conjunction with various internal and external stakeholders, investigates and coordinates the resolution of deviations through comprehensive use of Root Cause Analysis tools.
  • Devises and implements CAPAs to address root cause and ensure effectiveness.
  • Collaborate with technical and operational stakeholders, writes and/or revises SOPs, batch records, technical reports, and other operational related documents if required.
  • Generate training material and conduct training for manufacturing staff.
  • Execute and collaborate with MFG and cross functional SMEs on Human Error Reduction CAPAs/Right First Time Initiatives.
  • Drive and own improvement projects that support department KPI’s, with a focus on cost, innovation, on-time delivery, and quality. Manage projects from concept to completion; create and manage project plan, work cross- functionally and provide adequate training to impacted areas.
  • Generate and Manage Metrics.
  • Act as back-up to Manufacturing Management to perform Validation Protocol Review and approval.
  • Support the implementation of new processes in close collaboration with Program Managers, Process Transfer/Process Development, Engineering, MSAT, QA and Validation team.
  • Identify new technology for new/current assets and assist with identifying user requirements, procurement, and implementation as needed.
  • Collaborate with engineering and validation teams to implement and qualify new equipment and controls.
  • Represent the interests of the Manufacturing team, serve in multidisciplinary project teams, working closely with other team members in a cooperative fashion to ensure project progression.
  • Be actively engage in Inspection Readiness activities and support internal and regulatory audits as needed.
  • Adhere to cGMPs is always required during the manufacture and release of APIs. All personnel own the quality of what they deliver and are responsible for notifying management in a timely manner for serious GMP deficiencies, process deviations, product defects and relevant actions.
  • Perform other duties and projects as assigned, according to the changing needs of the business.


Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • BS Degree in Engineering or equivalent technical discipline
  • 3+ years of Biotech/Life Science/Pharmaceutical Biologics GMP Manufacturing related experience is required.


Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • Facilitation and demonstration skills
  • Independent collaboration with outside resources
  • More advanced knowledge / proficiency with business software (i.e. Excel, Visio) and industry systems (LIMS, ERP) General knowledge of Quality/Regulatory GMP requirements in a biologics Pharma/ Biotech industry.
  • The knowledge, understanding, and application of cGMP’s as it relates to Commercial operations.
  • Excellent written (especially technical writing), presentation and verbal communication skills.
  • Superior planning, time management and coordination skills and be able to readily adapt to changes in priorities and project schedules.
  • Attention to detail and good investigation, problem-solving skills.
  • Prioritize and deliver work in a fast-paced, deadline-driven environment.
  • The ability to adapt rapidly to a changing industry and be able to adjust responsibilities, time, and objectives accordingly.
  • Strong skills in Microsoft Office, especially in Word, Excel, and PowerPoint.
  • Very strong attention to detail.


#LI-GSK

Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees.

Why Us?

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 positively impact the health of 2.5 billion people by the end of 2030.

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.

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