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