Shire Operations Specialist 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 support the development of a plasma processing facility that will bring the company additional capacity for fractionation, purification, and fill and finish for its biologic medications. Drive manufacturing deliverables to ensure successful commercial operations. Author and revise GMP documents and manufacturing records (e.g. SOPs, Job Aids, etc.) Train staff in general manufacturing activities. Collaborate in the mitigation of any environmental, Health, and Safety (EHS) needs and risks. Identify and implement improvement initiatives to improve yield, reliability, and/or process robustness. This may require leading and implementing change controls. Demonstrate continuous improvement with respect to increasing job knowledge and proficiency related to the biopharmaceutical industry, as well as technical understanding/problem solving capability Stay current with biopharmaceutical industry best practices and technologies. Responsible for organizing data and preparing appropriate documentation including presentation materials for assigned projects.

CAPA investigator Lead any CAPA investigations: Lead problem solving and root-cause analysis sessions Interact with Quality, Engineering and Tech Service units Manage complex investigations using DMAIC tools Ensure effective implementation of corrective and preventive actions

Change Control Specialist Change Controls (CC) main point of contact for multiple manufacturing units, including but not limited to: Multiple CCs Owner in Track-wise system (e.g. materials, process, equipment, IT systems, etc.) Project manage CCs implementation Ensure appropriate CC assessments are timely completed Coordinate CC implementation with all necessary teams Ensure staff is appropriately trained on changes Ensure documentation quality and regulatory compliance Typically requires bachelor's degree, preferably in science, engineering or other related technical field. 2+ years of related experience. Minimum two years relevant professional (GMP industry) experience required. Demonstrated ability to perform in a high performing workforce. Strong problem-solving and analytical skills are required. Possess knowledge of core manufacturing principles and support systems. Must have excellent organizational, verbal and written communication skills; able to efficiently communicate with cross- functional teams and management on recommended course of action, with minimal assistance. Self-driven individual that requires minimal supervision. Must have proficient computer skills and be experienced using MS Office software (Word, Excel and PowerPoint). Prefer experience in Track-wise system. Prefer experience in Automation Control Systems, EBM (Electronic batch Record), PI Historian. Prefer knowledge of Lean Six-Sigma methodology.

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.