Shire Process Engineer II in Social Circle, Georgia

Takeda 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 will be a team member of the Process Engineering group. Process Engineering is responsible to ensure that the manufacturing equipment/systems used in the production, storage, testing and distribution of Takeda products are fit for purpose in accordance with Takeda standards and industry regulatory requirements.

The Engineer is responsible for design, purchasing, installation, troubleshooting, qualification, operation and maintenance of process equipment and systems including, but not limited to, manufacturing equipment such as: process tanks, Clean in Place (CIP), parts washers (COP), chromatography, ultrafiltration, aseptic fill line equipment, packaging equipment, centrifuges, and filter presses. This position will provide support to manufacturing system. The Engineer will implement area and system improvements through strict adherence to Standard Operating Procedures and cGMP’s in a Pharmaceutical Manufacturing facility.

Responsible for designing, developing, implementing and evaluating optimal, cost-effective projects and technologies. Act independently with minimal supervision to conduct smaller approved projects. Document development work including writing specifications for manufacturing or scientific test results. Solve engineering tasks, investigate and trouble shoot issues with some oversight. Trend ongoing issues and develop/implement long term engineering solutions. Define initiate and implement proposed solutions. Provide technical support for equipment in manufacturing, as second level support. Gain knowledge of systems to grow into a Subject Matter Expert (SME) role. Support Quality and technical investigations. Support planning and execution of start-up and validation, working in a cross-functional team Assist in driving projects to completion and meet timeline and budget objectives, may lead small projects. Create or update written Standard Operating Procedures (SOPs) related to project assignments. Create or update technical specifications and drawings (Design/Functional/System/P&ID) related to project assignments. Expected to make suggestion on improvements based on recent technical knowledge. Able to contribute to cost estimating of major capital budget items and the spending of approved project funds. Investigate and analyze manufacturing issues and design improvement suggestions. Recommend design improvements. Bachelor's degree in Engineering discipline required. 2+ years of related experience. Knowledge of the basic principles in various engineering disciplines. Must know how to effectively run projects and direct the activities of a technician. Experience working in an FDA-regulated manufacturing environment is desired. Knowledge of core principles in various engineering disciplines including manufacturing (i.e. cell culture/fractionation//purification/aseptic filling/packaging/cGMP facility design), support systems (WFI/RO/clean steam/compressed gases/HVAC) and facility design is desired. Must have excellent organizational, verbal and written communication skills; Able to efficiently communicate with cross-functional teams and management. Must have proficient computer skills and be experienced using MS Office software (Word, Excel and PowerPoint) and MS Project. Must possess basic knowledge of core principles in various engineering disciplines (fluid mechanics, heat transfer, thermodynamics etc.).

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Equal Employment Opportunity

Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

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Reasonable Accommodations

Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.