BFS Technician (Equipment Technician) - days

Woodstock Sterile Solutions (WSS)

WSS is the leading North American blow-fill-seal (BFS) sterile contract development and manufacturing organization (CDMO). From our 430,000 sq ft advanced aseptic manufacturing facility in Woodstock, Illinois, we leverage 50+ years of BFS technology leadership and our patented cold BFS process to serve clients across ophthalmics, respiratory, biologics, and diagnostics markets. We are committed to Proven Excellence. Trusted Solutions.

Position Overview

This is an entry-level opportunity to build a career in advanced aseptic BFS manufacturing. The BFS Technician Level 0 learns basic BFS theory, personal protective equipment (PPE) use, tool handling, and core processes such as BFS start-up, machine and tank sterilization, filter integrity testing, temperature recorder function, set-up drawing interpretation, and batch record documentation. This role requires aseptic gowning certification as a prerequisite to entering the Aseptic BFS Suite. This position is a growth pathway upon completing training and qualification, employees advance to BFS Technician Level 1. This position will be scheduled to work Thursday - Saturday and every other Wednesday, 5:45AM - 6:00PM, and is eligible for a $1/hour shift differential for the 12-hour shifts.

Key Responsibilities

• Learn basic BFS theory and process overview, including start-up/shutdown, media fill batches, line clearance, filter testing, temperature recorders, and machine/tank sterilization
• Wear proper Personal Protective Equipment (PPE) at all times
• Utilize safe work practices (proper tool use, bending/lifting techniques, chemical awareness, slip/trip/fall awareness, etc.)
• Read batch record instructions and set-up drawings
• Conduct daily audits of cGMP paperwork completed by self and co-workers, ensuring proper Good Documentation Practices (GDP)
• Comply with all controlled documentation and cGMPs as they pertain to production
• Certify in aseptic gowning performance
• Inspect product for defects and package product on the packaging line
• Display effective communication skills with peers and management
• Adhere to all safety requirements specified in controlled documentation and equipment manuals
• Maintain effectiveness of Quality System components relevant to the role
• Identify, evaluate, and manage risk to ensure product quality; communicate risk policies and processes throughout the organization
• Other duties as assigned

Qualifications

Education

• High school diploma required
• Associate degree or technical certification a plus (mechanical, electrical, etc.)

Experience

• Minimum of 1 year of experience with hydraulic or pneumatic machines (e.g., injection mold or aseptic filling) required
• Minimum of 1 year of experience in mechanical troubleshooting and repair
• Knowledge of clean room procedures a plus

Knowledge, Skills & Abilities

• High level of attention to detail
• Familiarity with current Good Manufacturing Practices (cGMP) and safe work practices
• Excellent documentation skills, utilizing GDP with the ability to review for accuracy and logic
• Strong mechanical aptitude
• Strong problem-solving and analytical skills incorporating basic mathematical and reasoning abilities
• Strong written and oral communication skills
• Works well in a team environment, under pressure, and able to prioritize/multi-task
• Able to interact effectively across departments, with suppliers, managers, and site leadership
• Able to perform risk assessments in a timely manner and respond accordingly
• Capable of independent work related to projects and/or routine activities
• Sound judgment, active listening, and a bias toward action; fosters teamwork to get results
• Demonstrated ability to read, write, and speak clear English

Physical Requirements

• Ability to stand for up to 12 hours per day
• Visual acuity of 20/30 (corrected)
• Frequent sitting, standing, walking, climbing ladders/steps, stooping, kneeling, crouching, reading, computer monitor use, reaching, handling, grasping, and twisting
• Occasional walking on inclines/uneven terrain, writing, talking, balancing, and carrying
• Frequent lifting/moving up to 20 lbs; occasional lifting/moving up to 50 lbs

Notice to Agency and Search Firm Representatives: Woodstock Sterile Solutions is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Woodstock Sterile Solutions employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Woodstock Sterile Solutions. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Woodstock Sterile Solutions