GSK is currently looking for a Project Design Lead to join our This role will manage the front-end engineering of large and/or complex capital projects of value > $10m. Front end engineering includes determining business objectives, identifying process technology and delivery strategies, providing project definition, and owning the technical delivery and project management through its governance. Responsibilities are by first intent for projects executed within the US, but could support global projects as team portfolio evolves. Fluency in (bio)pharmaceutical processes, facilities, operations, market developments, engineering methods, and GSK standards in project management, operations, quality, and EHS are essential.

Key Responsibilities:

• Lead in the business analysis, feasibility, and conceptual design of new or modifications to existing (bio)pharmaceutical processes of medicines and vaccines - including bioreactors/fermenters, chromatography, filtration skids, formulation, and filling to meet technical, budget, and schedule goals. Contract with strategy and manufacturing sites to develop project objectives and develop plans to progress designs and funding to deliver and define projects. Draft project plans, define budgets, define schedules to implement. Consult on process designs, equipment selection, procurement methods, quality implications, and then implement the approved modifications.

• Knowledge of current engineering services market offerings and practices to ensure effective engagement and understanding. Knowledge of cGMP and market trends in automation, validation, construction to ensure project execution excellence and continuous improvement. Knowledge of benchmark costs and durations to effectively plan projects.

• Lead discussions and recommend solutions with key customer groups in order to gain a consensus on objectives, scoping, options for implementation, and effectively negotiate changes. Follow up on projects' status and arising issues/changes with all relevant parties (customer, finance, procurement and engineering departments).

• Be personally responsible for the coordination of all engineering activities and interactions with engineering, equipment, and construction firms over the various phases of project lifecycle.

• Ensure EHS corporate standards, local legislation, and other Quality and Regulatory requirements are included while planning and executing all projects. Also, ensure proper identification and assessment of potential EHS risks that are significant to the business and that can be eliminated or minimized before or during project implementation. Apply corporate EHS standards related to employee's safety during construction/ demolition processes to achieve zero reportable injury rate, with continuous supervision and control on contractors' activities.

Basic Qualifications:

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

• BS degree in engineering or equivalent technical discipline
• At least 8 years of prior project and/or process engineering experience in the pharmaceutical industry.

Preferred Qualifications:

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

• MBA, Masters in Engineering, and/or Professional Engineer
• At least 15 years of prior project and/or process engineering experience in the pharmaceutical industry is preferred.
• Prior project experience in the design, construction, start-up and operation of large bulk biopharmaceutical drug substance AND drug product fill / finish facilities.
• Demonstrated ability to manage projects >$10m to completion on time and within budget (minimum), preference for >$50m.
• Familiar with cGMPs, GEPs.
• Detailed understanding of Design, Installation, and Commissioning / Qualification / Validation of new pharmaceutical equipment and/or utilities.
• Must be able to interact well with peers, subordinates, and senior personnel in scientific, engineering, and operational disciplines.
• Demonstrated ability to participate as a leader or member on cross-functional and self-directed work teams.
• Must be comfortable and thrive in ambiguity and think strategically to solve complex problems.

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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.

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