Manufacturing Associate

Takeda • Ops, ND

9d • $19 - $30 • Onsite

About The Position

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.

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

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