Manufacturing Associate - Roller Bottle

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

With general supervision the individual will perform routine and critical manufacturing operations, including but not limited to work functions in Cell Culture, Purification, Solution & Equipment Prep areas. Operates production equipment according to SOPs for the production of clinical and/or commercial products. Responsibilities: Describe the essential daily job functions. % of Time Job Function and Description 80% This individual will carry out cGMP manufacturing operations utilizing Standard Operating Procedures (SOP), Batch Records and Form Preps. Primary responsibilities include the following  Troubleshoot and resolve basic process related issues  recognize and escalate deviation  Execution of critical and routine activities in support of production  Perform Batch Record, Log Book and Form Prep requests  Enter data in the Laboratory Information Management System (LIMS) , MODA and or other business functions  Review GMP documentation  Sample preparation and testing  Identify changes needed to documentation  Participate in tiered visual management system and support CI initiatives  Complete required training on time Job Description Template 2 10% This individual will manage equipment and support facility related projects by  Initiating work orders  Assembly and disassembly of process equipment  Perform scheduled cleaning of equipment  Perform standardization of equipment  Support change over activities  Execution of equipment and process qualifications as well as validation 10% Staff Technical Training and Development  Maintain training requirements  Develop and maintain personal development plan  Provide annual performance self-assessment on development plan Education and Experience Requirements Include educational requirements or equivalency, required years and type(s) or experience, and necessary licenses or certificates. Specify which are required and which are preferred. For UK, please do not use years of experience due to UK Legislation Essential:  Normally requires a high school diploma and 2-4 years related industry experience or an Associate’s Degree in Life Sciences/Engineering field with 1 year of GMP Manufacturing experience. Desired:  Biotech Certificate preferred Key Skills, Abilities, and Competencies Describe critical skill and abilities needed to successfully perform the job, which should be representative of the knowledge, skills, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Significant understanding of general aspects of the job with a broad understanding of the detailed aspects of the job.  May be required to perform as a subject matter expert for equipment and/or systems  The individual is proficient at following written instruction in the form of Batch Records, Form Preps, Technical Protocols and Procedures.  Possess excellent communication and troubleshooting skills.  Full awareness of current Good Manufacturing Practices.  Proficient computer skills.  Will work holidays and overtime as required.  May be required to adjust work schedule to meet production demands.  Proficient in Aseptic Technique  Ability to work cohesively in a team environment  Ability to wear personal protective equipment such as safety glasses/goggles, gloves and safety shoes.  Ability to gown and gain entry to biotechnology/pharmaceutical manufacturing areas.  Ability to lift, pull or push equipment requiring up to 25-50 lbs. of force. Job Description Template 3  Ability to stand for 6 hours in a production suite.  Ability to climb ladders and work platforms.  Stooping or bending to check or trouble-shoot equipment operations.  Ability to work around chemicals (alcohols, acids & bases). Complexity and Problem Solving Describe the decisions made by the incumbents on a regular basis. Include decisions within the Incumbent’s authority to make as well as those decisions that must be referred to a higher level. Works on assignments that are moderately complex in nature where judgment is required in resolving problems and making routine recommendations.  Basic trouble shooting skills  Receives assignments in the form of objectives with goals and process to meet goals outlined. Work is reviewed by supervisor to measure meeting of objectives.  Accomplishes tasks mainly through direct operation of cGMP activities.  Performs daily operations of the work unit and actively assists coworkers in fulfilling department goals elevating issues to senior staff.  Evaluate and elevates issues to senior staff.  Identifies process deviations, troubleshoots issues and identifies process improvements. Internal and External Contacts List contacts this job advises, consults, or coordinates with on a regular basis. Describe to whom the job is accountable. Indicate each Contact category (Internal, Vendor, Customer, or Other) and provide examples. Internal  All Internal Manufacturing, Materials Management. Technical Operations and Facilities Management with limited exposure to support groups (Quality Assurance, Validation, Quality Control, Process Development and Health, Safety & Environment) Vendor  May require interaction with equipment, technical and supply item vendors. Other Job Requirements List any other job requirements, including travel, physical abilities required, etc.  May require weekend or holiday off shift support as needed Please be aware that this position is considered “Essential Personnel.” This means that in the case of inclement weather (e.g. snow storm) the employee who occupies this position may be expected to report to work for their normal shift if management deems necessary. To ensure “Essential Personnel” are safe during inclement weather situations Shire may provide lodging, shuttle service, and food (depending on the severity and duration of the inclement weather event). These details will be provided by management prior to any potential inclement weather situation.

Locations

Worker Type

Worker Sub-Type

Time Type