Manufacturing Associate

Takeda • Lexington, MA

19h • $19 - $30 • Onsite

About The Position

About the role: 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. This individual will carry out cGMP manufacturing operations utilizing Standard Operating Procedures (SOP), Batch Records and Form Preps. You will report to Manufacturing Supervisor. This is a day shift role, with working hours from 6:00 a.m. to 6:30 p.m. on a rotating 2-2-3 schedule, which includes working every other weekend. How you will contribute: Troubleshoot and resolve basic process related issues Recognize and escalate deviation Execution of critical and routine activities in support of productions Perform batch record, log book and form prep requests Enter data in the Laboratory Information Management System (LIMS), MODA and other business functions Review GMP documentation Sample preparation and testing Identify changes needed for documentation Participate in tiered visual management system and support CI initiatives Complete required training. Initiate work orders Assemble and disassemble process equipment Perform scheduled cleaning and standardization of equipment Support change over activities Execution of equipment and process qualifications as well as validation Maintain training requirements Develop and maintain personal development plan Provide annual performance self - assessment on development plan What you bring to Takeda: Normally requires a high school diploma and 0 or more years of experience or an Associate's Degree in Life Sciences/Engineering field. Biotech Certificate would be ideal. Proficient at following written instruction in the form of Batch Records, Form Preps, Technical Protocols and Procedures. Proficient computer skills. Full awareness of current Good Manufacturing Practices. May be required to perform as a subject matter expert for equipment and/or systems Basic trouble shooting skills Proficient in Aseptic Technique Important Considerations: At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may: Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas. Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment. Work in a cold, wet environment. Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary. Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection. May be required to adjust work schedule to meet production demands Ability to lift, pull or push equipment requiring up to 25-50 lbs. of force Ability to stand for 6 hours in a production suite Ability to climb ladders and work platform Stooping or bending to check or trouble-shoot equipment operations. Ability to work around chemicals (alcohols, acids & bases). 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.

Requirements

• Normally requires a high school diploma and 0 or more years of experience or an Associate's Degree in Life Sciences/Engineering field.
• Proficient at following written instruction in the form of Batch Records, Form Preps, Technical Protocols and Procedures.
• Proficient computer skills.
• Full awareness of current Good Manufacturing Practices.
• May be required to perform as a subject matter expert for equipment and/or systems
• Basic trouble shooting skills
• Proficient in Aseptic Technique
• Ability to lift, pull or push equipment requiring up to 25-50 lbs. of force
• Ability to stand for 6 hours in a production suite
• Ability to climb ladders and work platform
• Stooping or bending to check or trouble-shoot equipment operations.
• Ability to work around chemicals (alcohols, acids & bases).

Nice To Haves

• Biotech Certificate would be ideal.

Responsibilities

• Troubleshoot and resolve basic process related issues
• Recognize and escalate deviation
• Execution of critical and routine activities in support of productions
• Perform batch record, log book and form prep requests
• Enter data in the Laboratory Information Management System (LIMS), MODA and other business functions
• Review GMP documentation
• Sample preparation and testing
• Identify changes needed for documentation
• Participate in tiered visual management system and support CI initiatives
• Complete required training.
• Initiate work orders
• Assemble and disassemble process equipment
• Perform scheduled cleaning and standardization of equipment
• Support change over activities
• Execution of equipment and process qualifications as well as validation
• Maintain training requirements
• Develop and maintain personal development plan
• Provide annual performance self - assessment on development plan

Benefits

• U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
• U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED
• Number of Employees: 5,001-10,000 employees