enVista

Cleanliness and Contamination Control Manager

enVista • $105K — $128K *
Yorba Linda, CA 92886In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • Bachelor's degree in a scientific discipline; Microbiology or Biology preferred
  • 2+ years of experience in contamination control, specifically within medical devices or pharmaceuticals
  • Knowledge of regulatory requirements related to cleanliness and contamination control
  • Experience with ISO 13485 and ISO 11137 - 1&2 sterilization (Gamma irradiation)
  • Familiarity with cleanroom standards (ISO 14644, ISO 14698, ISO 8573)
  • Expertise in statistical data analysis and project management
  • Experience with ERP systems, SAP preferred

Responsibilities

  • Define and maintain contamination and cleanliness control strategies
  • Drive improvements in cleanroom setup, product final cleaning, and tool hygiene
  • Create and update control procedures; ensure compliance
  • Lead investigations of contamination incidents and monitoring excursions
  • Oversee cleanliness and contamination monitoring
  • Analyze contamination control data to identify trends and corrective actions
  • Serve as a subject matter expert during operations and audits

Benefits

  • Medical, dental, and vision benefits
  • 401K match
  • Potential for an annual performance bonus
  • Other applicable compensation plans
Full Job Description
Job Description:

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

Responsibilities:
  • 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 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:

QUALIFICATIONS:
  • Bachelor's degree in a relevant scientific discipline; Microbiology or Biology is a plus
  • 2+ years of experience in the field of contamination control; medical device or pharmaceutical experience is required
  • Solid knowledge of regulatory requirements related to contamination control and cleanliness control or ability to rapidly develop expertise to function independently with minimal supervision.
  • ISO 13485 experience (QMS for pharma or medical device)
  • ISO 11137 - 1&2 sterilization experience (Gamma irradiation)
  • ISO 14644, ISO 14698, ISO 8573 series experience required (Clean room & utilities)
  • ISO 10993-1 required (standard for evaluating the biological safety of medical devices within a risk management process)
  • Solid expertise in statistical data analysis
  • Project management experience
  • ERP experience; SAP is a plus


PREFERRED:
  • Analytical Methods preferred (ISO 11737-1,2,3)
  • Comprehensive experience of manufacturing process needs to meet cleanliness requirements is a plus
  • Experience in working in a highly ambiguous matrix organization is a plus
  • Good interpersonal skills with ability to work effectively with other groups
  • Excellent verbal & written communication skills
  • Strong interpersonal skills with a high level of accurateness, integrity, commitment, ethics and proactivity to cultivate a network of productive relationships in an international matrix environment
  • 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
  • Analyzes issues and breaks them down. Makes documented, systematic and rational judgments based on relevant information
  • Fluency in English and the local language is mandatory, other languages are welcome


#LI-RJ1
IND123

Target Market Salary Range:

Actual compensation packages take into account a wide range of factors that are unique to each candidate, including but not limited to geographic location; skill sets; relevant education and certifications; depth of experience; performance; and other business and organizational needs. The disclosed reasonable estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Envista, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. The total compensation package for this position may also include an annual performance bonus, medical/dental/vision benefits, 401K match, and/or other applicable compensation plans.

$105,200 - $128,600

Operating Company:
Nobel Biocare

About enVista

enVista is a global software solutions and consulting services firm headquartered in Carmel, Indiana. The company provides consulting, implementation, and managed services in supply chain, transportation, retail, and IT. enVista's services include supply chain strategy, transportation management, warehouse management, labor management, and IT services. The company has offices in North America, Europe, and Asia.
Learn more about enVista
Size
11,200 employees
Market Cap
$5.3 billion
Industry
Information Technology
Net Income
$33.3 million
Founded
2002
5 Year Trend
-2.1%
Revenue
$2.2 billion
NASDAQ
NVST
* Ladders Estimates

Similar Jobs

Ad banner background

Get Ready For Your
Next Interview

More Jobs at enVista

More Pharmaceuticals & Biotech Jobs

Find similar Cleanliness and Contamination Control Manager jobs:

NationwideYorba Linda, CA