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Department Specialist, Albumin

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 Department specialist position is responsible for executing and strictly adhering to cGMP, environmental health and safety guidelines, and any other related regulation which could apply. Department specialist will support daily operations of the fractionation department ensuring that log books are reviewed and corrected in a timely manner, EBM work orders are addressed, general supply inventory, and communication with support groups for key activities taking place on the floor. Additionally the department specialist will contribute to a culture of safety first in compliance with Environmental, Health, and Safety (EHS).
In addition, the Department Specialist is expected to:
+ Ensure timely and accurate generation of process documentation, and review documentation
+ Issue, and review documents.
+ Generate work orders.
+ Must have customer services and leadership attitude to take ownership of any problem.
+ Train others on complex processes and explain process to others.
+ Understand supplier/customer process streams and interdependencies.
+ Must possess the ability to work independently and effectively with peers, and display strong interpersonal and organizational skills.
+ Operate various HMI screens (PLC, Delta V) in support of process equipment (i.e. washer, autoclave, filling line, cap machines, etc.).
+ Follow instructions for completion of job tasks.
+ Complete written documentation of work performed.
Requirements:
Education and/or Experience :
+ High school diploma or equivalent required. Associate degree preferred.
+ Experience in a regulated environment desirable.
+ Must have working knowledge of GxP principles.
+ Minimum 2-5 years of experience
+ At least 2 years of maintenance experience with a focus on pharmaceutical, food industry, and/or laboratory equipment, troubleshooting & repair within a cGMP environment
+ At least 1 year experience in a clean room or GMP/regulated manufacturing environment
+ Must be able to read and follow detailed written/electronic instructions and have good verbal/written communication skills.
+ Must be able to read, write and converse in English.
+ Must be proficient in a variety of mathematical disciplines and be able to work with both the metric and US standards of measurement.
+ Must have good interpersonal skills and be able to work effectively and efficiently in a team environment.
+ May require immunization before performing work within the manufacturing area.
+ Must demonstrate importance of working in a regulated environment.
+ Must have the knowledge and ability to use a personal computer, electronic mail systems and navigate and conduct searches on the intranet.
+ Must have and display the following personal attributes: Integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.
_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?s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire 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 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 is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, 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.
EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf
EEO is the Law ? Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
Reasonable Accommodations
Shire 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.
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
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.


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