Cleaning Specialist

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
** We are PCI.
** Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Job Description
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* Job Title:

Cleaning Specialist
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* 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.
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* Essential Duties and Responsibilities:

** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities are the following but other duties may be assigned.
* 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 blood borne 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.
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* Qualifications:

** The requirements listed below are representative of the knowledge, skill, and/or ability required…