Mechanical Engineer (Senior Level)
o BS in Mechanical Engineering
o 5+ years of engineering experience in a mechanical engineering discipline
o Knowledge of cGMP's and FDA requirements
o Knowledge of facility / plant systems and infrastructure
o Ability to work well under pressure with tight timelines
o Excellent communication and analytical skills
o Must be flexible, adaptable and a strong team player
o Capable of managing multiple projects simultaneously
o Technical knowledge across multiple areas; mechanical, electrical and controls to fully understand overall system designs and functionality
o Demonstrate teamwork, personal effectiveness, customer focus, decision making, and influencing skills
o Capable of reading and interpreting ISA standards, P&ID's, instrumentation and electrical wiring diagrams
o Certified Professional Engineer or Engineering in Training is preferred
o Very knowledgeable on the principles of Validation and cGMP's
o Excellent in MS-Office, MS-Project, SAP and AutoCad
o Excellent communication skills and ability to influence effectively at all levels within the organization
o Demonstrate initiative and analytical problem solving skills - ability to use and interpret data to drive decision making at both tactical and strategic level
o Lean Sigma / Green Belt Certification desired
To execute the major elements of the site Facility Engineering Strategy and provide mechanical engineering expertise to the Zebulon site within a multi-disciplinary team of engineers, project managers, validation specialists, and sub-contractors. This role provides technical knowledge in the mechanical engineering discipline for the support of site facility systems and infrastructure. This includes providing engineering design and construction expertise, ensuring that systems and field work is done in accordance with engineering drawings, specifications and GSK design guides and providing troubleshooting support when needed.
o Act as a Mechanical Duty Holder
o Provides expertise to the site in engineering discipline area and has ownership of certain critical systems.
o Provides support of colleagues by providing them with engineering oversight in discipline area and supports their design reviews.
o Develops and/or reviews standards and SOP's applicable to the department.
o Plans and implements the design, installation, maintenance of mechanical systems and infrastructure such as HVAC, Chilled water, Steam, Air, USP, & other bulk gas/liquid distribution systems.
o Understands the functionality and design of these systems and can support facility maintenance in troubleshooting / issue resolution.
o Provides subject matter expertise in mechanical engineering to other Project Managers/project teams and supports larger projects as an individual contributor. This includes providing input during design reviews and ensuring submitted designs meets the GSK and local standards.
o Investigates and solves technical problems that involve equipment and processes that affect product quality and equipment reliability.
o Works with appropriate parties to investigate all adverse equipment and facility related events. Ensures robust corrective actions are in place to prevent recurrence of problems.
o Plan and manage small projects, including all aspects of the project delivery process from scope definition, justification and planning to completion / closeout.
o Responsible for assuring an outcome which meets all of the defined project objectives including safety, quality, cost, timelines and business benefit.
o Identify, contractually engage and performance manage engineering firms, vendors, equipment manufactures and construction contractors to support the project delivery.
o 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.
o Responsible for ensuring the successful completion of commissioning, turnover and closeout activities, including acceptance testing, training, corrective work.
o Review, generate, and assist others with project documents ensuring technical accuracy and cGMP compliance (ie. FRS, SDS, Change Controls, Commissioning, Validation, SOP's, Maint. Plans, FAT's, SAT's etc.)
o Interface and partner with the GSK community of Shared Services, Centers of Excellence and other
sites to contribute, share, and leverage technology and maintain standards as appropriate.
o Ensure that systems and processes are continuously improved by performing routine GEMBAs and process confirmations, and performing problem solving.
o Utilize and continuously improve towards the goal of Zero accidents, Zero defects and Zero waste.
o Provide subject matter expertise during regulatory inspections and interact with auditors as necessary.
You may apply for this position online by selecting the Apply now button.
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