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Position : Manufacturing Associate Location:Mailford MA Duration: 12 Months 2nd Shift - Monday-Friday, 3:30 p.m. – 12:00 a.m Job Description: As part of Shire’s Milford, MA, manufacturing plant’s Purification team, the Manufacturing Associate is responsible for executing purification processes and ancillary tasks related to the production of Obizur, a commercial biologic treatment for Acquired Hemophilia-A. The Manufacturing Associate works in strict compliance with cGMP regulations and all applicable company regulations. This is a 2nd shift position, Monday-Friday , 3:30 p.m. – 12:00 a.m. Length of assignment is through December 31, 2017. • In this hands on position, operate process equipment in downstream manufacturing performing processes such as (1) Column packing and qualification, column chromatography, depth filter clarification, nanofiltration and drug substance dilution, (2) Automated and manual chromatography skid systems, filter systems and mixing systems. • Operate BSC’s, microscopes, incubators, mixing equipment, pH meters, conductivity meters, autoclaves, and other support equipment. • Cleans equipment and parts for use in CGMP operations using manual systems and a Glassware washer. Prepares equipment and assemblies to be autoclaved. • Independently complete required documentation and may guide other operators on proper GMP recording of entries and comments in batch records, forms and protocols. • Perform real time Production Batch Record review prior to submission to supervisor. • Clean equipment and parts for use in cGMP operations using manual systems and Glassware washer. Prepare equipment and assemblies to be autoclaved. • Lead/participate in 5S and Lean initiatives including tracking metrics, posting on visibility boards, communicating program updates to personnel at all levels of the organization EDUCATION AND EXPERIENCE HS diploma with 5-7 years of related work experience in a GMP environment; or, AS degree with 3-5 years of related work experience; or, Bachelor’s degree with minimum of 1-3 years of GMP biologics manufacturing experience. Degree in a scientific discipline preferred. The following attributes are also essential to this position: • Attention to Detail - being careful about detail and thorough in completing work • Adaptability/Flexibility - being open to a variety of schedules according to changes in production • Dependability - being reliable, responsible and fulfilling obligations especially in regards to working in a team environment Technical Knowledge • Production/Processing - Knowledge of raw materials, production processes, quality control, costs, and other techniques for maximizing the effective manufacture of pharmaceutical products. Includes knowledge of aseptic technique and basic lab instruments, (pH Meter, Conductivity Meter, Scales, etc.) • Safety/Security - Knowledge of relevant equipment, policies and procedures to promote effective and safe operations for the protection of people, data and company property Skills & Abilities • Operation and Control - Controlling operations of equipment or systems • Quality Control Analysis – Ensuring that products are evaluated for quality during the manufacturing process • Mathematics - Using basic mathematics to solve problems • Problem Sensitivity - Ability to tell when something is wrong or is likely to go wrong. It does not involve solving the problem, only recognizing there is a problem • Judgment/Decision Making - Considering the relative costs and benefits of potential actions to choose the most appropriate one • Manufacturing environment with potential chemical, electrical and physical hazards • Personal protective equipment must be worn in the laboratories according to Shire’s safety requirements. • Possible exposure to cool/hot storage conditions. • May be around moving equipment and machinery. • May work around chemicals such as solvents, acids, bases and reactive or flammable materials. • Pace may be fast and job completion demands may be high. May be required to stand for long periods of time while performing physical duties. Must be willing and able to wear Personal Protective Equipment (PPE). May be required to lift up to 30 lbs. Must be able to work safely with materials and equipment. WORKING ENVIRONMENT AND PHYSICAL DEMANDS Vinay Kumar - Talent Acquisition Executive *KCS* *(*Keshav Consulting Solutions) . 1000 Bearcat Way Suite 105 Morrisville, NC 27560. Direct : 919-278-7724 Email ID: vi...@keshavconsulting.com Website: www.keshavconsulting.com <http://www.google.com/url?q=http%3A%2F%2Fwww.keshavconsulting.com&sa=D&sntz=1&usg=AFQjCNF93qZrjxju58n9mZNX7wcFf5owTw> -- You received this message because you are subscribed to the Google Groups "oraapps" group. To unsubscribe from this group and stop receiving emails from it, send an email to oraapps+unsubscr...@googlegroups.com. To post to this group, send email to oraapps@googlegroups.com. Visit this group at https://groups.google.com/group/oraapps. For more options, visit https://groups.google.com/d/optout.
