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February 17 2018

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Offer: Manufacturing Associate II:Alexion Pharmaceuticals

Job description:

Manufacturing Associate II

Alexion Pharmaceuticals


   » Roscommon
   » Not disclosed
   » Permanent full-time
   » Updated 12/02/2018
   » HR this job is expired SaveSave Apply Now

Job detail


A key member in supporting the execution of operational readiness in Alexions manufacturing facility.
 

Position Summary
A key member in supporting the execution of operational readiness in Alexions manufacturing facility. The manufacturing associate will become SME in a number of unit operations all over the process and is responsible for executing batch operations as per standard operating procedures under limited supervision.

Principal Responsibilities
   » Operate manufacturing equipment and instruments
   » Complete assigned tasks in a timely manner
   » Conduct everyday activities in an organized, efficient manner
   » Perform simple, routine, complex, and critical operations
   » Troubleshoot equipment issues, when necessary
   » Ensure process equipment is appropriately maintained for operation
   » Perform and document operations in conformity with cGMP's
   » Execute equipment qualification protocols and validation protocols
   » Routinely draft and revise standard operating procedures and master batch records
   » Recognize and initiate process deviations
   » Support continuous improvement initiatives by identifying areas needing improvement, recommending strategies for improvement, and implementing those strategies once approved
   » Embrace Alexion Core Competencies
   » Train other staff.
   » Communicate effectively, written and verbal
   » Maintain training compliance
   » Ensure a safe working environment for all staff
   » Plan everyday activities and schedule operations
   » Perform deviation investigations and closure
   » Interact with other departments
   » Aseptic Filling with RABS in grade B background
   » Compounding / Formulation of products
   » Sterile Filling of vials / syringes using Isolator
   » Visual Inspection of finished product.
   » Cleaning and Sanitation of equipment
   » Operation of Parts washers and Autoclaves
   » CIP /SIP of Vessels.
   » Creation and revision of Documents
   » Support regulatory audits
   » Support all new product/process introductions on site.
   » Perform data collection, compilation, and statistical analysis
   » Interact with vendors and outside resources
   » Complete assigned projects
   » Be the shift lead if required, providing instruction to the team
   » Troubleshoot and resolve operational problems during processing
   » Represent Manufacturing in cross functional initiatives and meetings
   » Monitor and evaluate process trends and recommend and implement continuous improvement strategies as appropriate
   » Manage multiple projects independently
   » Plan and implement complex changes
   » Perform Environmental monitoring as required.
   » Technical expert for entire area(s)
   » Interact independently with regulatory agencies
   » Develop and provide training on complex manufacturing processes
   » Perform Manufacturing review and approval of critical documents
   » Develop process validation protocols
   » Maintain good housekeeping and clean and sanitize classified areas as required.
   » Analyze complex problems and determine and implement solutions

Qualifications
   » Must be able to work within and adapt to complex electronic systems such as SAP and Trackwise
   » Must be able to read, write and converse in English
   » Must have good working expertise of MS Excel and Word
   » capability to work in an intense, fast-paced work environment
   » capability to function, with guidance, in a rapidly changing environment while balancing multiple priorities simultaneously
   » capability to work independently and as part of a team
   » More than 2 years' practice in a cGMP biopharmaceutical manufacturing environment.

Education

• BA/BS in a scientific discipline or equivalent practice preferred.

Ref: 11486C
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Alexion Pharmaceuticals


   »
5 reviews

 


   » Alexion International Trading, College Business & Technology Park, Blanchardstown, Dublin 15
   » +353 (0) 1 254 6400
   » http://www.alexionpharma.com



Skills:

Job Category: Customer Service [ View All Customer Service Jobs ]
Language requirements:
Employment type:
Salary: Unspecified
Degree: Unspecified
Experience (year): Unspecified
Job Location: Roscommon
Company Type Employer
Post Date: 02/12/2018 / Viewed 7 times
Contact Information
Company: Alexion Pharmaceuticals


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