Cleanliness and Contamination Control Manager

3 days ago


Yorba Linda CA United States Envista Holdings Full time

Job Description:

The Cleanliness and Contamination Control Manager is responsible for ensuring cleanliness control and contamination control at the manufacturing site.

The Cleanliness and Contamination Control Manager is responsible to:

  • Define and maintain contamination control and cleanliness control strategies.
  • Drive improvements to enhance cleanliness control, including cleanroom setup, product final cleaning, tool cleaning, hygiene, and rules of conduct.
  • Create/update procedures for cleanliness and contamination control and ensure they are adhered to.
  • Ensure compliance with Quality Regulations, ISO, AAMI standards, and regional requirements.
  • Lead investigations of monitoring excursions, contamination incidents, and deviations from contamination and cleanliness control procedures.
  • Ensure monitoring related to contamination and cleanliness control is performed.
  • Analyze and interpret contamination control and cleanliness monitoring data, identifying trends and implementing corrective actions.
  • Act as a Cleanliness and Contamination Control Subject Matter Expert (SME) during routine operations and audits.

Job Requirements:

Required:

  • Bachelor’s degree in a relevant scientific discipline (preferably in microbiology)
  • 2+ years of experience in the field of contamination control in the medical device or pharmaceutical industry
  • Must reside within a commutable distance to Yorba Linda, CA.

Critical Skills/technical know-how:

  • ISO 13485 (Quality Management System for Medical Devices)
  • Sterilization (ISO 11137-1&2)
  • Analytical Methods (ISO 11737-1,2,3)
  • Clean room & Utilities (ISO 14644, ISO 14698, ISO 8573 series)
  • ISO 10993-1
  • Solid knowledge of regulatory requirements related to contamination control and cleanliness control or ability to rapidly develop expertise to function independently with minimal supervision.
  • Solid expertise in statistical data analysis
  • Good interpersonal skills with ability to work effectively with other groups
  • Excellent verbal & written communication skills
  • Strong organizational and multitasking skills with the ability to prioritize tasks independently to meet the objectives of multiple projects simultaneously
  • Strong analytical skills and result orientation
  • Fluency in English and the local language is mandatory, other languages are welcome
  • Sound SAP system understanding
  • Beneficial comprehensive experience of manufacturing process needs to meet cleanliness requirements
  • Experience in working in a highly ambiguous matrix organization

Critical Success Factors / Key Challenges:

  • Able to drive improvement projects simultaneously
  • Able to implement clear procedures that describe processes adequately and are regulatory compliant as well as efficient use of resources
  • Able to assess the impact of manufacturing changes (e.g. equipment, process, material, and environmental changes) on contamination and cleanliness control
  • Author, revise, and review technical and procedural documentation related to contamination and cleanliness control practices
#J-18808-Ljbffr

  • Yorba Linda, United States Kelly Services, Inc. Full time

    Cleanliness and Contamination Control Manager| Yorba Linda, CA | Temp to Hire | $90,000/yr |The Cleanliness and Contamination Control Manager is responsible for overseeing cleanliness and contamination control at a manufacturing site. This role ensures compliance with various standards and regulations, driving continuous improvement and maintaining high...


  • California, MO, United States Envista Full time

    Job Description: The Cleanliness and Contamination Control Manager is responsible for ensuring cleanliness control and contamination control at the manufacturing site. The Cleanliness and Contamination Control Manager is responsible to: Define and maintain contamination control and cleanliness control strategies. Drive improvements to enhance cleanliness...


  • Conshohocken, PA, United States PharmaLex GmbH Full time

    JOIN OUR CONSULTANT NETWORK! PharmaLex is a highly successful and growing consulting company for the Healthcare industry. Recently, we are receiving increase in demand for Contamination Control Consultants and our goal is to grow our consultant pool to prepare for these exciting and upcoming projects. We are committed in providing career opportunities in...


  • Yorba Linda, California, United States Michaels Stores Full time

    About MichaelsAt Michaels, we prioritize the wellbeing of our teams by providing robust benefits for both full-time and part-time Team Members. Our company is the leading creative destination in North America, operating over 1,300 stores in 49 states and Canada and online at Michaels.com and Michaels.ca.Job SummaryWe are seeking a Creative Events Manager to...


  • Yorba Linda, United States Ekman Associates Full time

    Title: Technical Project Manager Location: CaliforniaEkman Associates is a management consulting firm that specializes in developing business, digital, and technology strategy, delivering solutions, and addressing human resource demands. Summary: The Technical Project Manager will be responsible for decommissions, moves and/or update of equipment. This...


  • Yorba Linda, California, United States HOM Full time

    Job OverviewAt HYM LLC, we are seeking a detail-oriented Warehouse Operations Specialist to join our team. This is a part-time opportunity that requires the ability to handle inventory work efficiently and effectively.Key ResponsibilitiesOrder Fulfillment: Prepare and complete warehouse orders for delivery or pickup.Inventory Management: Receive and process...

  • Part-time Associate

    5 months ago


    Yorba Linda, United States Smart and Final Full time

    Part-time Associate (Cashier)925 - Yorba Linda ExtraStarting Rate: $16.25/hrDo you? Provide excellent Customer Service? Love your Community? Love Food? Join our Store Operations Team as a Part-time Associate (Cashier)!Store Location 21500 Yorba Linda Blvd Yorba Linda, California, 92887 United States The Opportunity The Part-Time Associate is the key to...


  • Barre, VT, United States Stowe Pest Control Full time

    Pest Control Technician, Full TimeStowe Pest Control, LLC is a successful family-owned business and is hiring a pest control technician to join our team. The successful applicant will be responsible for identifying, trapping, and removing various types of pests, as well as controlling future infestations. Experience is helpful but will train the right...


  • Yorba Linda, California, United States PACE SECURITY Full time

    Job SummaryP.A.C.E. Security is seeking a highly skilled Security Systems Technician to join our team. As a Security Systems Technician, you will be responsible for installing, servicing, and maintaining high-end access control, video management, and intrusion surveillance systems.Key Responsibilities:Install and test new CCTV, access control, and security...


  • Yorba Linda, California, United States PACE SECURITY Full time

    Job Summary:P.A.C.E. Security is seeking a highly skilled Security Systems Integration Specialist to join our team in the San Diego area. This full-time position offers a competitive salary of $38-$65 per hour, depending on experience, and an attractive benefits package including health insurance, 401(k) matching, paid time off, and professional development...


  • Yorba Linda, California, United States PACE SECURITY Full time

    Company Overview">P.A.C.E. Security is a leading provider of integrated security solutions for commercial and multifamily real estate, education, and hospital industries.">Salary">$45.00 per hour (commensurate with experience)">Job Description">We are seeking an experienced Electronics Security Specialist to join our team. As a key member of our installation...

  • Sanitation Manager

    4 weeks ago


    Fullerton, CA, United States swipejobs Full time

    Job DescriptionLeads/follows up on all vendors that support the sanitation function and programs.Follows all Plant Safety processes and protocols.Responsible for fair and timely evaluations of all employees in his/her area of responsibility.Responsible to conduct team meetings that are meaning full and offer the sanitors the opportunity to express themselves...


  • San Francisco, CA, United States Gulfstream Strategic Placements Full time

    Job Title: Controls Project ManagerLocation: San Francisco, CAJob SummaryWe seek a highly skilled and motivated Controls Project Manager to lead cutting-edge building automation projects in the heart of San Francisco, CA. This role is a unique opportunity to leverage your technical expertise in BACnet, DDC controls, and advanced control systems while...


  • Yorba Linda, United States Enterprise Security, Inc. Full time

    Job DescriptionJob DescriptionMake a Positive Career Change in 2024! Maximise your chances of a successful application to this job by ensuring your CV and skills are a good match.ENTERPRISE SECURITY is a premier commercial security systems integrator for the Southern California area and we are seeking an experienced security systems engineer. Why work for...


  • Yorba Linda, United States PACE SECURITY Full time $25 - $50

    COMPANY OVERVIEW   P.A.C.E., Inc has immediate openings for Low Voltage -- Security Systems Integration Technicians / Installers in OC and LA Areas.  Are you bored in your job doing the same thing day after day?  How about joining our professional Team of Security Installation Technicians?  At P.A.C.E. you will find a rewarding career in a field that...


  • Yorba Linda, United States PACE SECURITY Full time $30 - $45

    COMPANY OVERVIEW P.A.C.E., Inc has immediate openings for Low Voltage -- Security Systems Integration Technicians / Installers in the San Diego area.  Are you bored in your job doing the same thing day after day?  How about joining our professional Team of Security Installation Technicians?  At P.A.C.E. you will find a rewarding career in a field that is...


  • San Diego, CA, United States Calportland Full time

    Job Summary The Quality Control Intern will support the Quality Control team with various tasks, including assisting with mix designs, performing field and lab testing, maintaining equipment, and preparing reports. This internship is designed to provide hands-on experience in quality control processes and concrete material testing in a professional...


  • San Francisco, CA, United States Goeverbright Full time

    Job Overview The Internal Controls Manager is responsible for overseeing the company's Sarbanes-Oxley (SOX) compliance program and internal controls that are determined by the markets we serve. Job Duties & Responsibilities Planning and managing all activities related to annual SOX compliance assessments, including documentation of key controls, risk...


  • Yorba Linda, United States Marukai Corp. Full time

    Description ESSENTIAL DUTIES in Customer Service Department (Retail Associates) (responsibilities include, but are not limited to) Providing premier customer service, including greeting them and responding to questions to all customers and staff Responds quickly and in a friendly manner to customer inquiries and complaints Engaging in suggestive selling and...


  • San Diego, CA, United States Calportland Full time

    Job SummaryThe Quality Control Intern will support the Quality Control team with various tasks, including assisting with mix designs, performing field and lab testing, maintaining equipment, and preparing reports. This internship is designed to provide hands-on experience in quality control processes and concrete material testing in a professional...