Associate Manufacturing Specialist

Job description

Nombre del sítio: USA - Pennsylvania - King of Prussia
Fecha de publicación: Feb 21 2024

Job Purpose

We make and supply medicines and vaccines all around the globe and our teams own every production stage, from creating quality products at our manufacturing sites to designing effective supply forecasting and regulatory inspections; all powered by digital, data and analytics. We operate at impressive scale, producing over 1.7 billion packs of medicine and 767 vaccine doses in 2021.

We continue to modernize, so we can launch even more new products at speed whilst turbo-charging delivery across our entire portfolio through our relentless focus on quality, safety, and service. The way we work will change. For some, the shift in technology and products will be revolutionary. Our R&D pipeline demands a new kind of supply chain, and we need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of automation and robotics so we can work smarter together.
 

The Associate Manufacturing Specialist will be part of a high performing team responsible for delivering the supply of GSK products to the One Biopharm supply chain. They will demonstrate GSK Values (Patient Focus, Transparency, Respect, & Integrity) and Expectations (Courage, Accountability, Development, & Teamwork) on a daily basis by engaging positively with team members and production support groups. The associate manufacturing specialist, with support from team leads and supervisors, will perform a mix of tasks ranging from operation of GMP equipment, to leading pieces of work associated with supporting new product introduction and/or improvement of existing processes.  The work this role will support will follow the lifecycle of new products, more specifically: Equipment/Facility Design, Technology Transfer, Commissioning & Qualification, Start-up & Engineering Batch manufacture, Process Performance Qualification batch manufacture, Clinical Supply, Commercial Supply, Changeover, Process Improvement.

This role will provide YOU the opportunity to lead key activities to progress YOUR career.  These responsibilities include some of the following:

·  Demonstrate GSK Values – Patient Focus, Transparency, Respect, and Integrity – in every interaction, in every work task, and with every responsibility of the job role. Live GSK’s Expectations of Courage, Accountability, Development, and Teamwork to achieve high performing behaviors in the workplace.
·  Adhere to safety procedures and training requirements in accordance with site, GSK, and federal regulations including the proper use of controls, personal protection equipment, and waste handling practices. Escalate equipment and processing issues that pose a safety or compliance risk.
·  Understand production equipment systems in use and P&ID diagrams of production equipment. Serve as technical experts for the production process and owners of production equipment.
·  Follow ALCOA (Attributable, Legible, Contemporaneous, Original, Accurate) principles for all documentation of performed tasks. Own Commissioning/Qualification/Validation protocols, deviation investigations, writeups, and management of corrective and preventative actions.
·  Support delivery of key product lifecycle deliverables from various functional groups (Production, Engineering, Technical, Validation, etc.) for new, or changes to existing, equipment and processes.  Draft, review and/or execute documents and protocols (i.e. component/system assessments, specifications, equipment testing, ERP data collection, SOPs, batch documents, equipment or process qualification).  Own and manage Deviations, CAPAs, and AL1/AL2 change controls.
·  Schedule and track activities which (directly or indirectly) impact the schedule of manufacturing and/or required documentation.  Manage inventory of raw materials and single-use components, execute Batch Document revisions, and perform the role of Lead Investigator through the use of Enterprise Resource Planning (ERP) systems at site.
·  During Engineering, PPQ, Clinical or Commercial manufacturing campaigns: train on and perform GMP operations in the seed lab (aseptic processing), cell culture, media and buffer prep, equipment prep, purification, and final fill (aseptic processing) production areas based on standard operating procedures (SOPs) and digitalized technologies.  Expectation is that during manufacturing campaigns, this role spends up to 80% of time in the production suite, supporting operations directly as needed.
·  Identify and implement process improvements (i.e. reduce material waste, improve productivity) and required documentation updates, within the controlled systems of the site.  Own production area metrics as part of the GSK Production System.
·  The associate manufacturing specialist may be responsible for availability as on-call personnel, remotely monitoring, and working occasional weekend or night coverage as needed.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

·  Bachelors of Science, or Bachelors of Arts

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

·  BS or BA degree

Please visit  GSK US Benefits Summary to 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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