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 Ophthalmics.
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.
The position support the manufacturing for downstream process equipment in a new, state-of-the-art plasma purification facility that will bring Shire additional capacity for testing, purification, and fill and finish for its biologic medications.
The position will play a support role as the Engineering representative for the purification/bulk process area (i.e. suspension, depth filtration, ultrafiltration).
This position will be responsible for assisting in developing, evaluating and implementing cost-effective equipment improvements in a fast-paced cGMP, biotechnology environment. This includes numerous phases and activities of a project including: start-up, de-bugging, optimization, commissioning, validation, conformance lots, routine manufacturing, contractor and consultant supervision and creating and executing change control documentation.
Essential Duties and Responsibilities
• Support equipment in manufacturing as second level support (SME)
• Support the planning and execution of start-up and validation by working in cross-functional teams.
• Assist in driving projects to completion and meet timeline and budget objectives
• Create or update written Stand Operating Procedures (SOPs) related to project assignments.
• Create or update technical specifications (Design/Functional/System) related to project assignments.
• Demonstrate continuous improvement with respect to increasing job knowledge and proficiency related to engineering in the biopharmaceutical industry, as well as technical understanding/problem solving capability.
• Stay current with biopharmaceutical industry best practices and technologies
• May perform other duties as assigned
Education and/or Experience:
- Must have excellent organizational, verbal and written skills.
- Able to efficiently communicate with cross- functional teams and management on recommended course of action, with minimal assistance.
- Must have proficient computer skills and be experienced using MS Office software (Word, Excel and Powerpoint).
- Must have the ability to effectively act as a contributing member of a team for Engineering projects, coordinate contractors, and drive results.
- Must possess basic knowledge of core principles in various engineering disciplines (fluid mechanics, heat transfer, thermodynamics etc.)
- Must have good interpersonal skills and be able to work effectively and efficiently in a team-based environment.
- Has the ability to prioritize multiple tasks and work on multiple projects simultaneously.
- Must be a self-starter, detail oriented and able to work independently with minimal supervision.
- Must embrace working in a fast-paced, team-oriented, cross-functional environment.
Education and/or experience
B.S. degree required in an Engineering discipline with the preference being Chemical, with a minimum of 0-3 of experience in an engineering role within the pharmaceutical, biotechnology or FDA regulated industry.
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