Cleaning Specialist

Cleaning Specialist

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Job Title : Cleaning Specialist

Location : Assembly

Shift : 1st Shift

Summary of Objective :

Dedicated and detail-oriented Cleaning Specialist to join our team. In this role, you will be responsible for ensuring the cleanliness and sterilization of our production equipment tooling; ensuring functionality of our machinery and adherence to the production schedule, which is crucial for maintaining optimal production efficiency. Your work will play a vital role in supporting our commitment to quality and safety standards.

Essential Duties and Responsibilities :

• Perform thorough cleaning and sanitization of all production equipment tooling, including the disassembly and reassembly of product contact and non-product contact parts as specified by cleaning protocols.
• Follow established cleaning procedures for all production equipment tooling to prevent cross-contamination and ensure compliance with hygiene standards. Follow established policies, procedures, and safety regulations without deviation.
• Follow strict safety guidelines, wearing appropriate Personal Protective Equipment (PPE).
• Safely and effectively use appropriate cleaning agents and chemicals, following specific mixing and usage guidelines.
• Mix and prepare cleaning solutions according to safety guidelines.
• Use and dispose of cleaning chemicals and other hazardous materials safely and responsibly, in accordance with safety data sheets (SDS).
• Visually inspect cleaned tooling / equipment to ensure the production equipment tooling is free of product debris or residue from previous production run prior to releasing. Inspect tooling / equipment to identify potential quality issues, damage, or areas needing attention or immediate repair.
• Wrap and secure tooling / equipment to maintain 60-day sanitization period while being transported and stored.
• Maintain accurate records of cleaning activities to support operational transparency.
• Maintain clean room sanitization through daily, weekly, monthly, and annual cleaning process routines.
• Monitor and replenishes clean room inventory and coordinates inventory order requests with the lead / supervisor.
• Ensure compliance with cGMP, corporate standards / PCI Quality System (PQS), site policies / procedures, regulatory requirements, and industry standards. Communicate regularly and effectively. Work cross functionally to ensure communication within the business is always up-to-date and utilizes all available channels.
• Effective communication skills to coordinate with team members and report issues to supervisors.
• Maintains attention to detail and quality while completing multiple or repetitive tasks and meeting product timelines.
• Partner with the PCI Validations department to prepare, execute, and close out validation documentation for tooling and process validation.
• Partner with Quality Systems to issue and reconcile PCI functional department logbooks. (Production, Maintenance, Quality).
• Perform documentation and records review of completed logbooks to ensure compliance with cGMP's and customer requirements.
• Ensure all documentation aligns with quality standards, regulatory requirements, and company policies.
• Strong understanding of quality assurance principles and regulatory practices is essential for this role.
• Use and effectively navigate PCI EDMS to obtain controlled documents and training relating to job role.
• Reads, understands and communicates information contained in controlled documents.
• Complete and attend required annual bloodborne pathogen training to stay informed about dangers and safe procedures.
• Responsible for the safe and thorough cleaning, disinfection, and removal of blood and other potentially infectious materials (OPIM) from a variety of settings.
• Participate in all required PAPR training sessions, medical evaluations, and fit testing to ensure competence and proper function of the equipment.
• Follow all required safety protocols, including wearing a PAPR in designated areas or during specific tasks that pose a respiratory hazard.
• The skill to prioritize tasks and work efficiently to meet deadlines.
• The capacity to work effectively with minimal supervision.
• Attendance at work is an essential function of this position.
• This position may require overtime and / or weekend work.
• Performs other duties as assigned by Manager / Supervisor.

Qualifications :

The requirements listed below are representative of the knowledge, skill, and / or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Required :

Preferred :