Glaxosmithkline Zebulon , NC 27597
To execute the major elements of the site Facility Engineering Strategy and provide project management expertise to the Zebulon site within a multi-disciplinary team of engineers, validation specialists, and sub-contractors.
This role provides project management knowledge in the support of site facility systems and infrastructure. This includes providing engineering design and construction expertise leadership and project execution, ensuring that systems and field work is done in accordance with engineering drawings, specifications and GSK design guides and providing troubleshooting support when needed.
Plan and manage all aspects of the project delivery process from scope definition, justification and planning to completion / closeout. Responsible for assuring an outcome which meets all of the defined project objectives including safety, quality, cost, timelines and business benefit.
Utilizes industry / GSK standards for project management, identifying the right tools to be used for a project to ensure the project is managed and delivered to the project goals.
Design the project organization structure, define team member roles and assign individual work responsibilities. Lead, manage and supervise the project team.
Consult with, advise and provide regular communications updates to key project stakeholders. Clearly define business drivers, objectives, success criteria and progress for projects with the sponsor.
Identify, contractually engage and performance manage engineering firms, vendors, equipment manufactures and construction contractors to support the project delivery.
Coordinates the work of external construction contractors, vendors and manufacturers and ensures design and construction meets regulatory codes and standards as well as GSK standards.
Understands the roles, responsibilities and expertise of other specialists within Engineering, and knows when to engage these specialists when needed.
Responsible for ensuring the successful completion of commissioning, turnover and closeout activities, including acceptance testing, training, corrective work, etc.
Review, generate, and assist others with project documents ensuring technical accuracy and cGMP compliance (ie. URS / Design documents, Change Controls, Validation, SOP's, Maint. Plans, FAT's, SAT's etc.)
Ensure that systems and processes are continuously improved by performing routine GEMBA's, process confirmations, and performing problem solving.
Utilize and continuously improve towards the goal of Zero accidents, Zero defects and Zero waste.
Provide subject matter expertise during regulatory inspections and interact with auditors as necessary.
Why You?Basic qualifications:
BS in Engineering.
5+ years of project management experience managing facility equipment / infrastructure projects.
Knowledge of cGMP's and FDA requirements.
Knowledge of facility / plant systems and infrastructure.
Ability to work well under pressure with tight timelines.
Excellent communication and analytical skills.
Must be flexible, adaptable and a strong team player.
Capable of managing multiple projects simultaneously.
BS in Engineering in Mechanical, Electrical, Civil/Structural, Instrumentation & Controls or related engineering disciplines.
Knowledge across multiple areas; mechanical, electrical and controls to fully understand overall system designs and functionality for making sound decisions on projects.
Experience in a pharmaceutical, biotech or other highly regulated industrial environment.
Demonstrate teamwork, personal effectiveness, customer focus, decision making, and influencing skills.
Capable of reading and interpreting ISA standards, P&ID's, instrumentation and electrical wiring diagrams.
Certified Project Management Professional (PMP) is preferred.
Very knowledgeable on the principles of Validation and cGMP's
Excellent in MS-Office, MS-Project, SAP and AutoCad.
Excellent communication skills and ability to influence effectively at all levels within the organization
Demonstrate initiative and analytical problem solving skills - ability to use and interpret data to drive decision making at both tactical and strategic level
Lean Sigma / Green Belt Certification desired.
At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. We need a talented and motivated workforce to deliver against our strategy. To achieve this, we strive to attract the best people and to create an environment that empowers and inspires.
We have a significant global presence with commercial operations in more than 150 countries, around 100,000 employs, a network of 89 manufacturing sites, and large R&D centers in the UK, USA, Belgium and China. We have more than 27,000 people in global manufacturing and supply (GMS), across 86 sites in 36 countries. Together, these people help to produce 4 billion packs of medicine.
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