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PTS Floor Support Engineer II

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POST DATE 9/8/2016
END DATE 10/20/2016

Shire Pharmaceutical Lexington, MA

Company
Shire Pharmaceutical
Job Classification
Full Time
Company Ref #
14527BR
AJE Ref #
576117289
Location
Lexington, MA
Experience
Mid-Career (2 - 15 years)
Job Type
Regular
Education
Bachelors Degree

JOB DESCRIPTION

APPLY
Job Description
PRIMARY ROLE
The individual will be expected to support ongoing operations on the manufacturing floor. Troubleshoot process issues; monitor and evaluate process operation data for upstream or downstream operations including but not limited to cell culture roller bottle/bioreactor and capture step operations, filtration (NF, UF/DF) unit operations, chromatography column performance/integrity and drug substance formulation/bottling. Assist in the identification and implementation of continuous improvements aimed at consistency and robustness of process operations including training initiatives with manufacturing staff. Responsibilities also include weekend call-in coverage on a rotating schedule.

RESPONSIBILITIES
70%
Floor Support Troubleshoot process issues; monitor and evaluate process operation data for upstream or downstream operations including but not limited to cell culture roller bottle/bioreactor and capture step operations, filtration (NF, UF/DF) unit operations, chromatography column performance/integrity and drug substance formulation/bottling.

15%
Continuous Improvement Work with manufacturing staff to identify opportunities to improve the consistency and robustness of process operations. Assist in development of training initiatives.

15%
Quality System Support Support consistent and well documented response to process operations events to support investigations, deviation closure as well assistance to change control/CAPA as appropriate.

EDUCATION & EXPERIENCE REQUIREMENTS
BS in Engineering or Chemistry with 2-5 years or MS with 1-3 years of process development / commercial manufacturing experience in a GMP environment, preferably related to cell culture and/or purification of recombinant proteins

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.

EQUAL EMPLOYMENT OPPORTUNITY
Shire is an equal opportunity employer. Shire evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

EEO is the Law
EEO is the Law - Supplement
Pay Transparency Policy

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.

Minimum Requirements
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