Downstream Manufacturing Associate III (Contract - Wed-Sat 4/3 Day Shift, 6a-6:30p)

Duties And Responsibilities

• Perform operations of the following (may be applicable to commercial scale product, development studies, clinical scale or validation activities)
• Strong knowledge and understanding of manufacturing process and equipment to perform various production steps
• Ability to train employees
• Subject matter expert operating production equipment, as needed
• Monitor and record batch parameters, including computer data entry
• Complete relevant paperwork following GDP/GMP guidelines as well as perform mathematical calculations related to production processes
• Initiate new documents for procedures; may make minor revisions to existing documents
• Work with support team on all necessary event investigations and inventory system cycle counts and discrepancies
• Troubleshoot process problems and respond to alarms. Provide information for unplanned events, including entering data into event management software
• Oversee training of new employees, track training requirements for team members ensuring appropriate training is completed prior to process execution
• Order, receive and distribute supplies into production area as needed
• Pushing buffer containers ranging from 50L to 200L
• Sitting for periods of 2 to 3 hours
• Knowledge of laboratory and pharmaceutical production equipment including but not limited to: autoclaves, process tanks, chromatography skids and columns, analytical equipment
• Convey information to external stakeholders (auditors, global colleagues, etc.) and oversee support for groups that support manufacturing (such as external cleaners, etc.)
• Lead Continuous Improvement Teams (such as 5S, Gemba, OMT, etc.)
• Demnstrate procedures as a part of training sessions for other team members; may schedule department or process activities which could involve coworkers
• Provide knowledge in areas of training process improvements
• Such additional responsibilities as the Company may also assign

Qualifications

• With high school diploma: Normally requires 6+ years of related experience required or an associate degree in Life Sciences/Engineering field. Biotech Certificate preferred
• With Bachelor’s degree: Normally requires 3+ years of related experience
• Demonstrated knowledge of CGMP manufacturing
• Knowledge of laboratory and pharmaceutical production equipment
• Able to read and follow detailed written instructions and have good verbal/written communication skills
• Able to write legibly and grammatically correct entries on records; must be able to author technical procedures and create forms
• Familiar with standard troubleshooting approaches (problem statement, root cause analysis, corrections, etc.)
• Good computer skills, knowledge of Microsoft Word, Excel
• Able to work effectively and efficiently in a team environment
• Able to meet schedule required; this position may include shift, weekend, holiday work and overtime at times, as dictated by the 365-day per year production schedule
• Able to work in a clean room environment and comply with hygiene standards and use of special garments. Additionally, personal protective equipment must be worn due to safety requirements