Bioprocessing Manufacturing Technician

Job Description

Job Description

Shifts

Training - First 6 weeks

Monday - Friday (8:00 AM - 5:00 PM EST)

AFTER Training

Day Shift - 6:00 AM - 6:30 PM

Night Shift - 6:00 PM - 6:30 AM

Weekend Rotation

One Week - 2 Days On, 2 Days Off, 3 Days On

Other Week - 2 Days Off, 2 Days On, 3 Days Off

Job Purpose:

The Rockville Biopharma site exists to produce and deliver biopharmaceutical drug substance of the highest quality in a safe, compliant, reliable, and cost-effective manner for their patients. The vison is to be wholly entrusted to make innovative, high-quality medicines by leveraging the best talent & technology, on a platform of continuous improvement to supply every patient, every time.

Key Responsibilities:

• Preparation, cleaning, sterilization, batching, pasteurization, or filtration & delivery of media and solutions for cell culture & 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 & post use
• Perform process operations, equipment, and instrument monitoring & trending to enable proactive identification of issues to escalate and correct with applicable departments
• Set-up fixed & mobile process equipment and parts with CIP (Clean In Place) skids to carry out validated cleaning & sterilization processes
• Follow appropriate standard operating procedures (SOP’s), protocols, and batch records/logbooks to safely perform operations & 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 conditions.

Education, Knowledge, Experience Required:

Education

• Minimum Level of Education Required
• High School Diploma or Equivalency
• Preferred Level of Education
• Bachelor of Science/Art/associate ’s degree in Biological Sciences, Chemical Sciences, Engineering, or equivalent technical discipline.

Job Related Experience

Minimum Level of Experience

• 0-1 years of directly related Manufacturing experience in the pharmaceutical or biotechnology industry.

Compliance & Documentation

• Ability 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 & written communication skills
• Demonstrated ability to work effectively in a team
• Willing & able to work 24/7 rotating shifts

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 & emerging digital platforms.

Physical Requirements

Able to lift & carry materials up to 50 lbs.