Sterilization Manager

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JOB DESCRIPTION

Our client is currently recruiting a Manager of Controlled Environments & Sterilization to provide leadership and energy to its controlled environments and sterilization management team. This is an exceptional opportunity to join a corporate culture that is known for having an innovative and growth oriented vision. Responsibilities include:

1) Provide microbiological technical support for environmental monitoring and products in development and routine production
2) Facilitate bio-compatibility, toxicology and microbiological testing for medical devices
3) Co-ordinate and manage project validation runs at contract sterilizer and testing required at contract test labs
4) Participate in annual review of sterilization processes controlled by company or subcontract manufacturers and recommend any validation studies required to demonstrate continued compliance with internal procedures and regulatory requirements
5) Co-ordinate ethylene oxide sterilization validations and annual re-qualifications
6) Review and write ethylene oxide sterilization validation / annual re-qualification reports
7) Co-ordinate comparative resistance studies for ethylene oxide sterilization
8) Develop, write, implement and maintain quality system procedures for validation and routine control of sterilization and other relevant processes
9) Implement procedures for the control of sterilization clearance approval of new products or design / process changes
10) Prepare new product introduction or design change sterilization clearance requests for approval
11) Ensure that procedures for quarterly dose auditing are up to date and that the dose audits are performed on time
12) Perform ethylene oxide sterilization impact assessment for product design / manufacturing process changes
13) Participate in annual review of the environmental and final product test limits, and review the test limits in light of any significant process changes
14) Work with external contacts to communicate with customers, suppliers and contract labs for required micro specifications, testing methods and presentation of data
15) Provide investigation strategy for device sterility and bio-burden test failures and environmental deviations / excursions
16) Develop, write, implement and maintain procedures for the environmental control of manufacturing areas, and monitor requirements to demonstrate continued compliance with regulatory and standards requirements
17) Serve as bio-compatibility evaluation expert
18) Develop well designed bio-compatibility evaluation plans for successful product launches
19) Participate with product development group members to serve as a microbiological resource in an effort to reduce time to bring safe and effective products to market
20) Develop and maintain databases for sterilization validation studies, sterilization releases and environmental data
21) Co-ordinate lab testing of environmental samples and final product
22) Provide a monthly management activity report to the Departmental Manager
23) Review developing standards, regulations and reports to the Department Manager relaying any significant developments to ensure that company maintains compliance
24) Assist in meeting departmental goals and special projects as needed

CRITICAL REQUIREMENTS

  • 1) University degree is required (preference will be given to those with degree in relevant field, though all candidates are welcome and encouraged to apply)
    2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)
    3) Recent experience in the medical device industry is strongly preferred
    4) Preference will be given to people have recent experience in controlled environments and sterilization management

    If you believe you have the ability to excel in this role, this could be the right opportunity to work with a great company in the medical device industry.

COMPANY INFORMATION

Sterling-Hoffman is a retained executive search firm that specializes in representing life sciences and technology companies in matters of high impact talent acquisition. Our clients include market leaders and venture capital-backed startups in industries such as: medical device, biotechnology, pharmaceuticals, enterprise software, clinical research, and laboratory services. You may view more of our jobs here: http://www.sterlinglifesciences.com Your privacy is important to us: we will never share your resume without your permission. Please note that only qualified applicants will receive a response. We encourage you to apply for as many jobs as you believe you are a fit for, but strongly suggest that you include your salary information as job seekers who provide salary information are likely to be reviewed sooner. ===================== TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Biotechnology Recruiter, Pharmaceutical Recruiter, Medical Device Recruiter, Biotechnology Career, Clinical Research Job, Regulatory Affairs Job, R&D / Scientist Job, Product Manager Job, Medical Device Sales Job, Biotechnology Sales Job, Quality Assurance Job, Engineering Job, Laboratory Jobs, Microbiology Jobs, CEO Jobs, Marketing Jobs, Manufacturing Jobs, Oncology Jobs, Cardiology Jobs, Hematology Jobs, Medical Jobs

JOB INFORMATION

Seniority Level:
Management / Supervisory
Function:
  Manufacturing
Preferred Industry Background:
 
Managing a team of:
N/A
Required Travel:

Base Salary:
Confidential
Bonus:
Benefits:
Other Compensation:
A superb base salary and bonus structure are available; compensation is commensurate with experience and will be discussed with qualified candidates only.