Woodstock Sterile Solutions is driven to positively impact global healthcare by providing our partners the best quality solutions to their sterile development and commercial needs. We are a growing organization with a bright future, and we are looking for motivated and experienced team members. We offer a comprehensive benefits and a generous Paid Time Off package. This position will be scheduled to work Sunday – Tuesday and every other Saturday, 6PM – 6AM, and eligible for a 15% shift premium (overnights) and $1/hr shift differential (12-hour shifts).

I. Position Overview:

The position is entry level and responsible for learning the basic BFS theory, personal protective equipment, tool use, and comprehension of processes and methods such as: BFS start-up, machine and tank sterilization process, filter integrity test methods, temperature recorder function, reading set-up drawings and batch record documentation. This position is responsible for aseptic gowning certification as prerequisite to entering the Aseptic BFS Suite. New hire is not intended to stay in this position long term. Once training and qualification is completed at this level, employee advances to BFS Technician Level 1.

II. Specific Duties, Activities, and Responsibilities:

• Learn basic BFS theory and process overview including start-up and shutdown, media fill batches, line clearance, filter testing, temperature recorders, machine and tank sterilization.
• Wear proper Personal Protective Equipment (PPE).
• Always utilize safe work practices (i.e. Proper and safe use of tools, Proper Bending/Lifting techniques, Chemical Awareness, Slip/Trips/Falls awareness, etc.)
• Proper and safe use of tools.
• Read batch record instruction and set-up drawings.
• Conducts daily audits of cGMP paperwork filled out by themselves and co-workers following the completion of BFS activities. Ensure proper Good Documentation Practices (GDP) at all times when completing required documentation.
• 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 packaging line.
• Display effective communication skills with both peers and management.
• Adhere to all safety requirements specified in controlled documentation and in equipment manuals.
• Maintain effectiveness of the Quality System components relevant to this position.
• Identify, evaluate, and manage risk to ensure product quality. Communicate risk policies and processes throughout the organization.
• Other duties as assigned.

III. Position Requirements:

Education or Equivalent:

• High school diploma
• Associate Degree or Technical Certification a plus (mechanical, electrical, etc.)

Experience:

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

Knowledge/Skills Requirements:

• High level of attention to detail.
• Should be familiar with current Good Manufacturing Practices and safe work practices.
• Excellent documentation skills, utilizing Good Documentation Practices (GDP) with the ability to review for accuracy and logic.
• Strong Mechanical aptitude.
• Strong problem solving and analytical skills that incorporates basic mathematical and reasoning abilities.
• Strong communication skills both written and oral.
• Works well in a team environment.
• Works well under pressure and able to prioritize workloads as well as multi-task.
• Must be able to interact effectively with a variety of individuals and styles within and between departments allowing for direct interaction with outside suppliers, Managers and Site Leadership.
• Must be able to perform risk assessments in a timely manner and respond accordingly to improvements needed.
• Perform independent work related to projects and/or routine activities.
• Make sound judgments. Blend knowledge and analysis with logic, active listening, and a continuing interest in simplification. Act ethically.
• Demonstrate a bias toward action. Be proactive to get things done. Be willing to take a position, and assert influence to drive improvement. Foster 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 (20/30 corrected vision)
• Frequent sitting, standing, walking, climbing ladders/steps, stooping, kneeling, crouching, reading of written documents and use of computer monitor screen, reaching with hands and arms, handling, grasping, twisting
• Occasional walking up inclines and uneven terrain, writing, talking, balancing, carrying, listening
• Frequent lifting and/or moving up to 20 pounds and occasional lifting and/or moving up to 50 pounds

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.