Cleaning Tech 2-3rd Shift

The Cleaning Technician position is responsible for the disassembly, inspecting parts/assembly and cleaning of critical equipment associated with manufacturing equipment in the production of BacT/Alert bottles and VITEK MITUBE in a cGMP compliant manner. The position will require periodic infrastructure cleaning (maintain clean work environment). The position requires utilizing tools, cleaning chemicals, documentation, inspection, preventive maintenance, and disassembly of processing equipment, cleaning of manufacturing equipment parts and assembly of processing equipment, preparing bulk tubing kits and maintaining inventory. Additionally this individual will complete all applicable paperwork associated with cleaning records and equipment cleaning logs. This requires strong communication and team work with team members on different shifts. Access and understand use of Blue Mountain CMMS program to complete periodic scheduled PM's and forecast production schedule support needs.

Primary Duties:

1. Executes production activities per Manufacturing Directions, comply with all job related SOP instructions in a safe manner.

2. Perform daily manufacturing activities (process, equipment/component preparation and cleaning/sanitization of equipment and rooms) while ensuring adherence to company and GMP regulations, policies and procedures.

3. Assist with executing validation protocols associated with manufacturing equipment and procedures including revalidation as scheduled or required to maintain systems in a validated state to include working with other department.

4. Operates cleaning equipment, utilizing SOP and documentation to record data manually or through identified software applications.

5. Responsible for the sporicide cleaning of the manufacturing areas and following appropriate departmental cleaning procedures.

6. Ensure that all processes and procedures that are performed are documented in a timely manner in accordance with company and regulatory regulations.

7. Perform all job functions and responsibilities in a safe and responsible manner. Ensure compliance of co-workers with all safety policies and procedures at all times.

7. As necessary, provide assistance with the review and revision of Manufacturing Directions and SOPs necessary for the manufacture of product.

8. Perform all work in compliance with company quality procedures and standards.

9. Performs other duties as assigned.

Educations, skills and experience:

• High School Diploma, GED or equivalent
• Proficiency with GDP/GMP required, bioworks certication preferred
• 2 years experience as Process Technician, in an FDA regulated environment required
• Previous experience n the pharmaceutical/biotech industry and Bioworks Certification preferred.
• Knowledge of FDA/cGMP regulations and mechanical background preferred.
• Good documentation practices and attention to detail pursuant to FDA regulation preferred
• Knowledge of and experience in following OSHA regulations (LOTO, electrical safety, etc.) preferred
• Production background preferred
• Detail orientation to complete tasks without errors and produce high-quality work.
• Ability to generate and analyze reports, forecast production schedule, equipment needs and KPI's dealing with addition, subtraction, multiplication, and division of whole numbers, fractions, and decimals.
• Thriving in a fast-paced environment by managing tasks, multitasking, and adapting quickly to maintain productivity.
• Informing others by sharing clear, timely information to ensure alignment.
• Demonstrates perseverance and a focus on outcomes
• Ability to work cross-functionally allowing for better collaboration and communication when working across teams to achieve shared objectives
• Effective verbal communication skills
• Proficient in the use of computers and Microsoft Office tools to communicate shift summaries or follow up through e-mail.
• Build and maintain positive, productive interactions with colleagues
• Easily accessible and open to communication
• Participate in a way that enhances team performance and cohesion.
• Maintain composure by having the skill of staying calm, focused, and professional in high-pressure or stressful situations.
• Consistently uphold and reflects the core ethical principles and values that bioMérieux promotes

Working Conditions and Physical Requirements:

• Ability to remain in stationary position, often standing, for prolonged periods.
• Ability to ascend/descend stairs, ladders, ramps, and the like.
• Ability to wear PPE correctly most of the day.
• Ability to operate heavy machinery.
• Ability to adjust or move objects up to 50 pounds in all directions.
• Job requires frequent movement, standing and constant use of USP water to clean part. Repetitive activities and use of cleaning agents.
• Ability to work overtime and one weekend/month as required