Manufacturing Associate III

Role Summary

Responsibilities

• Independently assemble and/or operate biologics production equipment, such as bioreactors, filtration units, chromatography systems, and fixed/portable vessels while observing all cGMP requirements.
• Participate in cross functional projects teams, support technical transfers with relevant teams/individuals
• Support deviation investigations by completing deviation intake documentation.
• Perform complex trouble shooting and root cause analysis. May participate in resolving issues regarding operations.
• Document cGMP data and information for processing steps and/or equipment activities while following standard operating procedures. Key documentation includes batch records, work orders, and equipment logbooks.
• Independently perform/or assists with processing steps and/or manufacturing support activities by monitoring process parameters in batch record and control systems.
• Able to execute batch records and validation protocols independently.
• Author and review equipment use logs.
• Performs data entry into LIMS, SAP and coordinate sample delivery.
• Perform cleaning/sanitizing production equipment.
• Monitor complex to critical processes and identify if there is a deviation. May support and/or complete deviation investigations.
• Author and/or Review SOP and Batch Record revision and author change requests
• Participate in cross functional project teams and support technical transfers with relevant teams/individuals.
• Complete Batch Record review and assists with BR closure.
• Revise and/or create new manufacturing procedures.
• Apply technical knowledge to perform complex trouble shooting tasks and participate in departmental projects.
• Provides suggestions/ideas for corrective actions (CA) and preventative actions (PA) for non-conformances and/or safety events.
• Identify and recommend continuous improvements related to routine functions and implement after approval.
• Assist in incident/non-conformance generation and resolution.

Qualifications

• High school diploma or GED
• 3+ years experience in a GMP environment
• Associates degree or higher in a scientific discipline would be ideal.
• Experience with systems such as SAP, LIMS, Trackwise would be ideal.
• Proficient at following written instruction in the form of Batch Records, Form Preps, Technical Protocols and Procedures
• Demonstrated application of current Good Manufacturing Practices (cGMP‚Äôs) and Good Documentation Practice (GDP).
• Knowledge of non-manufacturing functions such as QC, Regulatory, QA, and/or Materials Management.
• Prior experience with lab equipment, computers, and intermediate mathematical skills.
• Knowledge of mathematical calculations (addition, subtraction, division, multiplication) and rounding.
• Ability to perform basic computer operations, such as ability to navigate in MS Office, use email, and complete training using Web Based Training (WBT).
• Experience with cGMP Biotech or Pharmaceutical operations.
• Mechanical ability/expertise; including understanding equipment function and application.
• Proficient and knowledgeable in the operation of two manufacturing areas or processes (i.e., downstream, upstream, media buffer, deviation writing).
• Possess equipment understanding, including understanding equipment function and application.

Skills

• Biologics production equipment operation
• cGMP and GDP compliance
• Documentation and data entry (LIMS, SAP)
• Troubleshooting and root cause analysis
• Technical writing and SOP/Bullet revision
• Cross-functional collaboration

Education

• High School diploma or GED required; Associate degree or higher in a scientific discipline preferred

Additional Requirements

• May be required to wear PPE and clean room garments; work in cold, wet environment; stand/walk for extended periods; lift up to 50 pounds; work multiple shifts including weekends