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.

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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,…