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BFS Operations Associate

2 months ago

Woodstock, Illinois, United States Woodstock Sterile Solutions Full time
Job Overview

Woodstock Sterile Solutions is committed to enhancing global healthcare by delivering top-quality solutions tailored to sterile development and commercial requirements. As a dynamic organization poised for growth, we seek dedicated and skilled individuals to join our workforce. We provide a robust benefits package along with a generous Paid Time Off policy. This role involves a schedule of Thursday to Saturday and every other Wednesday, from 6AM to 6PM, with eligibility for a $1/hr shift differential (12-hour shifts).

I. Role Summary:

This entry-level position focuses on acquiring foundational knowledge of BFS principles, safety equipment, tool utilization, and understanding essential processes and methodologies, including BFS initiation, sterilization procedures for machinery and tanks, filter integrity testing, temperature monitoring, interpreting setup schematics, and batch record documentation. Successful candidates will achieve aseptic gowning certification as a prerequisite for accessing the Aseptic BFS Suite. This role is designed for initial training, with progression to BFS Technician Level 1 upon completion of training and qualification.

II. Key Responsibilities:

  • Understand fundamental BFS principles and process flow, including initiation and shutdown, media fill batches, line clearance, filter testing, temperature monitoring, and sterilization of equipment.
  • Utilize appropriate Personal Protective Equipment (PPE) at all times.
  • Adhere to safe work practices, including proper tool usage, lifting techniques, and awareness of potential hazards.
  • Interpret batch record instructions and setup schematics accurately.
  • Conduct daily reviews of cGMP documentation completed by self and colleagues post-BFS activities, ensuring adherence to Good Documentation Practices (GDP).
  • Follow all controlled documentation and cGMP regulations relevant to production processes.
  • Achieve certification in aseptic gowning procedures.
  • Inspect products for quality assurance and assist in packaging operations.
  • Communicate effectively with peers and management.
  • Comply with all safety protocols outlined in controlled documentation and equipment manuals.
  • Maintain the effectiveness of the Quality System components pertinent to this role.
  • Identify and manage risks to ensure product quality, communicating risk policies throughout the organization.
  • Perform additional duties as assigned.

III. Position Requirements:

Education:

  • High school diploma.
  • Associate Degree or Technical Certification in mechanical or electrical fields is advantageous.

Experience:

  • At least 1 year of experience with hydraulic or pneumatic machinery (e.g., injection molding or aseptic filling) is required.
  • A minimum of 1 year of experience in mechanical troubleshooting and repair.
  • Familiarity with clean room protocols is a plus.

Knowledge and Skills:

  • Strong attention to detail.
  • Familiarity with current Good Manufacturing Practices and safe work practices.
  • Excellent documentation skills, with the ability to ensure accuracy and logical consistency.
  • Strong mechanical aptitude.
  • Problem-solving and analytical skills, incorporating basic mathematical reasoning.
  • Effective written and verbal communication skills.
  • Able to work collaboratively in a team environment.
  • Capable of performing under pressure and managing multiple tasks.
  • Ability to interact effectively with diverse individuals across departments.
  • Proficient in conducting timely risk assessments and implementing necessary improvements.
  • Ability to work independently on projects and routine tasks.
  • Demonstrated ability to make sound judgments and act ethically.
  • Proactive approach to completing tasks and driving improvements.
  • Ability to read, write, and communicate clearly in English.

Physical Requirements:

  • Capability to stand for up to 12 hours daily.
  • Visual acuity (20/30 corrected vision).
  • Frequent activities include sitting, standing, walking, climbing, stooping, kneeling, and using a computer.
  • Occasional tasks may involve walking on uneven surfaces, writing, and listening.
  • Regular lifting and/or moving of up to 20 pounds, with occasional lifting of up to 50 pounds.