Biopharmaceutical Associate I

Preparation, cleaning, sterilization, batching, pasteurization or filtration and delivery of media and solutions for cell culture and purification operations.

• Perform the set-up, operation, cleaning and break-down of process equipment.  Perform sampling procedures on various analytical instruments to analyze cell culture, solution and/or product concentration characteristics.
• Operate Filter integrity equipment to confirm the integrity of filters pre and post use.
• Perform process operations, equipment and instrument monitoring and trending to enable proactive identification of issues to escalate and correct with applicable departments.
• Set-up of fixed and mobile process equipment and parts with CIP (Clean-In-Place) skids to carry out validated cleaning and sterilization processes.
• Follow appropriate standard operating procedures (SOPs), protocols and batch records/logbooks to safely perform process operations and document compliantly with good documentation and data integrity practices.
• Follow all related safety policies and procedures and put safety first by playing an active role in identifying and correcting unsafe behaviors and condition

• Minimum Level of Education High School Diploma or equivalency
• Preferred Level of Education Bachelor of Science / Bachelor of Art / Associates Degree in biological sciences, chemical sciences, engineering or equivalent technical discipline.
• Minimum Level of Job-Related Experience required 0-1 year of directly related manufacturing experience in the pharmaceutical or biotechnology industry

Compliance & Documentation

• Able to follow detailed instructions and document accurately
• Practices good documentation and data integrity standards.
• Adheres to safety procedures and promotes a strong safety culture.

Communication & Teamwork

• Proficient in speaking, reading, writing, and understanding English  Strong verbal and written communication skills
• Demonstrated ability to work effectively in a team  Willing and able to work 24/7 rotating shifts

Continuous Improvement & Training

Understanding of operational excellence tools.

Technology Tools

• General proficiency with Microsoft Office (Excel, Word, Outlook).
• Basic knowledge of ERP systems (M-ERP) per global/local procedures.
• Familiar with automation systems and emerging digital platforms.
• Physical Requirements  Able to lift and carry materials up to 50 lbs