Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class products available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; a growing franchise in Oncology; and an emerging, innovative pipeline in Ophthalmic.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.
This position is responsible for project management of one or more projects at the Covington Ga. facility. Primary focus is on ensuring project deliverables meet user requirements and comply with all S h i r e expectations for safe and efficient operation, cGMP compliance, and technical process requirements. Responsible for managing multiple aspects of internal and external engineering / construction resources for capital projects. Responsible for day to day operational management of contract workforces. Responsible for compliance with all internal policies and external regulations governing project execution. Provide guidance and direction to contractors and Shire staff to ensure safe and efficient project execution to meet schedule and financial goals while ensuring technical success. Interfaces with design team, validation, quality, and operations to ensure to ensure successful project completion.
Plans, executes and functionally directs important engineering assignments, which require independent judgment.
Essential Duties and Responsibilities:
Review and approve the automation of process and support equipment and systems Design Drawings and Documents and Equipment Procurement Packages. Provide or lead efforts to ensure Process submittals are reviewed and approved for technical content In accordance with project schedule requirements. Provide leadership to assess and provide guidance and risk assessments regarding requirements for redundancies to equipment, controls and systems. Assist and guide the design and requirements with engineering firms. Applies state of the art techniques in the area of expertise to develop new or improved products and processes. May lead a large scale program or several small projects with complex features. Performs financial planning and assists in the analysts to justify project approval. Independently plans, schedules and leads cross-functional team . May supervise one or more engineers or technicians.
Experience pharmaceutical or food processing facilities, specifically Plasma fractionation and purification, design, installation and commissioning for projects. Experience implementing Lean Manufacturing concepts. Experience and Understanding of the Design, Build and Validation process for large renovations or new facilities. Must have experience or advanced training and demonstrate proficiency (e.g. computer-aided design, total quality. Demonstrates leadership skills. Extensive cross-functional team experience, including technical and non-technical work. Ability to organize and present technical and project mgt. overviews without assistance. Must be proficient in reading/review of process P&IDs especially with regard to instrumentation and automation. Knowledge of how to interface/integrate PLCs and other controller to s central process control and/or date acquisition system.
Associate college degree and/or 5 -10 years of relevant work experience.
Will occasionally work in a cleanroom environment and wear special garments (requires removal of make-up and jewelry.
Must occasionally wear personal protective equipment (e.g. hard hats, safety shoes, safety glasses, ear plugs) due to safety requirements In specific areas.
Will occasionally be exposed to dust, gases, moving equipment and machinery.
Will occasionally work around chemicals such as alcohol, acids, caustics. bleach that may require respiratory protection.
May occasionally climb ladders and stairs to higher elevations. May be required to work weekends, evenings, and off-hours, extended periods of time.
A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.