Site Name: USA - Pennsylvania - Marietta
Posted Date: Nov 14 2023
Are you energized by a highly visible Operational Readiness Director role that allows you to influence senior stakeholders and shape highly effective business partnerships? Are you an experienced greenfield project director today who is energized in starting up state of art facilities? If so, the Operational Readiness Director, could be an excellent opportunity to explore!
As Operational Readiness Director, you will be responsible to the overall success of a new strategic project in one of the biggest pharmaceutical/vaccines company in the world!
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following...
Directly lead multifunctional team through an implementation plan to introduce/start up new preparation, including formulation, filling, and inspection for a new building.Consider the implications of the project on future site Operations and Services resource requirements, to propose staffing levels covering numbers, grades, distribution, and supervision.Provide and manage operations resource plans for the implementation of the project, covering all protocols and manufacturing document preparation, manufacturing training manuals, and associated training, on and off-site (e.g. Control systems) activities.Implement appropriate training for all site Operations and Services staff, both those who are involved with project commissioning and those who will eventually run the plant.Ensure that site Operations and Services issues are addressed through all phases of the project life cycle.Ensure, in conjunction with other Project Team members, that the design of the plant and its operations will allow for safe and reliable processing in accordance with GMP, occupational hygiene, safety, and environmental protection policies.Influence the design and ensure that the new or modified plant is capable of being operated and supported appropriately to the process, including accessibility and local and remote controls, where applicable.Ensure that all site Operations and Services staff within the Product Stream or Business Area are kept fully aware of the Project, including project program, suspension of existing routine operations, plant layout changes/implications and accessibility.Coordinate with site Operations and Services, construction, and commissioning functions to establish robust Safe Systems of work (SSOW).Take a site Operations and Services management role during the commissioning exercise, and in that capacity prepare detailed process commissioning plans to meet the PQ requirements of validation in conjunction with Process Chemist and the Process Engineering Representative.Produce a report on commissioning and throughout the process commissioning procedure ensure that all EHS and GMP issues have been properly considered and that all work is thoroughly documented.Raise necessary control of change documentation for changes to the process and process control from the start of the PQ phase which is the interface between site compliance and project change control procedures.Ensure all site Operations and Services documentation and supplies necessary for putting the plant into operation are prepared and available.Coordinate all Customer input to the project as required via the Design Lead and Project Manager in accordance with the business and project objectives. Provide specialist site technical resources with detailed knowledge and information of existing and new hazards, processes, equipment and systems (e.g. automation and control) to advise and assist during the design and construction phases of the project and for participating in Value Management, Design Verification and Safety reviews. Facilitate access to site for the project (including contractors and vendors), and for planned business interruptions to accommodate project activities. Identify customer requirements for documentation for review and handover (including partial) and accept the completed facility on behalf of the customer.Coordinate closely with the Business Change and Benefits Manager.Support the Global Engineering PM to meet budget objectives and project schedule timelines.Potential to be ready soon for site head role after successful project completion.Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:Bachelor's degree in Engineering.10 Years of Project Management Experience.Pharma or Biotech industry experience required.End to End (Greenfield facility build through Validation, Tech Transfer, Approvals and Commercial production) experience.Aseptic fill experience required.Experience in stakeholder management.Experience with Greenfield projects of $300m and over.Experience hiring/building site teams quickly to meet project timelines.Preferred Qualifications:
If you have the following characteristics, it would be a plus:Professional Certifications a plus (such as PMP etc.).Cold Chain freezer experience.Lean Six Sigma Black Belt.Construction experience.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 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 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.
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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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