Cleanliness and Contamination Control Manager

Envista Holdings Corporation; Yorba Linda (CA); On-site; USD 105,000 - 129,000; Full time

Job summary

Envista Holdings Corporation is seeking a Cleanliness and Contamination Control Manager for its Nobel Biocare operations in California. This individual contributor role defines contamination and cleanliness strategies at the manufacturing site and leads investigations into excursions and deviations.

The ideal candidate has a Bachelor’s degree in a relevant science, 2+ years in contamination control (medical device or pharmaceutical), strong data analysis skills, ISO 13485 experience, and SAP

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 (biological safety of medical devices)
• ERP experience; SAP is a plus

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 SME during routine operations and audits.

Skills

Communication skills

Statistical data analysis

Project management

English language proficiency

Education

Bachelor’s degree in a relevant scientific discipline

Tools

SAP

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.

The 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.

The Job Requirements:

The 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

The 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

The 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

The Operating Company:

Nobel Biocare

Envista and all Envista Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available at: http://www.dol.gov/ofccp/regs/ compliance/posters/pdf/eeopost.pdf.

Envista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate. Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. An Agency must obtain advance written approval from Envista’s internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening. Envista will not pay a fee to any Agency that does not have such agreement and written approval in place.