Sterilization Manager
 LivaNova | |
$100,000 - $140,000 + discretionary annual bonus. Pay ranges may vary by location.
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401(k)
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 United States, Colorado, Arvada | |
| 14401 West 65th Way (Show on map) | |
 Apr 22, 2025 | |
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Join us today and make a difference in people's lives! LivaNova is a global medical technology company built on nearly five decades of experience and a relentless commitment to improving the lives of patients around the world. Our advanced technologies and breakthrough treatments provide meaningful solutions for the benefit of patients, healthcare professionals, and healthcare systems. The company is listed on the NASDAQ stock exchange under the ticker symbol " LIVN ." LivaNova is headquartered in London (UK) with a presence in over 100 countries and a team of more than 3,000 employees worldwide. Position Summary: This individual will participate in Arvada's critical sterilization project and will be responsible for supervision (once implemented) of the routine operations of ethylene oxide sterilization unit, including maintaining all compliance standards, record keeping, and documentation. As a Manufacturing Sterilization Manager, you will be the expert for our sterilization manufacturing process, process development, quality assurance and validations to achieve compliance with applicable FDA, ISO, ANSI and Company standards. Your initial primary focus will be to oversee the sterilization project itself as well as subsequent oversight of the routine operations of this new ethylene oxide sterilization unit. This is a high visibility role for our Arvada, CO facility. Essential Job Functions: - Ultimate goal is to provide the lowest production cost at the highest quality and the best services - Provide expert knowledge for ethylene oxide sterilization process - Provide expert knowledge about the microbiological aspects of sterilization such as biological indicators, bio-burden and endotoxin control, sterile barrier protection, sterilant residue evaluations, and all other processes having potential to impact product quality from sterility, cleanliness or biocompatibility perspectives - Create/Review/Authorize product and sterilization process control documentation and specifications through the company's document management - Provide direction, guidance and effective communication to all team members to ensure the team's understanding and achievement of quality, cost, delivery and safety goals - Assures the validation of the production processes and production machinery, following the execution of Installation Qualification, Operational Qualification and Performance Qualification and periodic re-validation plans - Assures the liaison with R&D and QA to ensure processes compliance inside the QSR guidelines - Play active part in CAPA process - Support the effective implementation and coordination of manufacturing processes and plant conducting - Play a key role in identifying process improvements and efficiencies that will enable highest yields, quality improvements and cost reductions - Closely monitor sterilizer performances, guarantee integrity of process, help to solve problems and deviations, and show reactivity and sound judgment - Implement more efficient operations, working cross-functionally with peers to drive changes and motivate teams - Support new products introduction by providing input to R&D, being an active part of the development team and assuring process scale up - Oversee production machinery and tools and maintains production equipment according to company standards and procedures Knowledge, Skills and Abilities Required: Experience in supervising personnel and complex activities in highly regulated contexts - Well rounded understanding of ISO, FDA, ANSI, ISO, EPA and USP requirements and ability to cross-reference and stay current with relevant regulations and standards - Knowledge and experience of QSRs - Applied knowledge of endotoxin and bio-burden monitoring, and routine biological indicators testing - Experience writing and presenting technical data, production figures and reports Education and Experience: -Bachelor of Science degree in Biology, Microbiology, Biomedical Engineering or closely-related life science is required. Master's Degree is preferred -10 + years of medical device (preferred), pharmaceutical, biological testing, or related R&D experience including extensive product sterilization background (commercial scale). Pay: A reasonable estimate of the annual base salary for this position is $100,000 - $140,000 + discretionary annual bonus. Pay ranges may vary by location. Benefits:
Valuing different backgrounds: LivaNova values equality and diversity. We are committed to ensuring that our recruitment process is fair, transparent and free from unlawful discrimination. Our selection process is driven by the key demands/requirements for the role rather than bias or discrimination on the basis of a candidate's sex, gender identity, age, marital status, veteran status, non-job-related disability/handicap or medical condition, family status, sexual orientation, religion, color, ethnicity, race or any other legally protected classification. Notice to third party agencies: Please note that we do not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Recruitment Services Agreement, we will not consider, or agree to, payment of any referral compensation or recruiter fee. In the event that a recruiter or agency submits a resume or candidate without a previously signed agreement, we explicitly reserve the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency. Beware of Job Scams: Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons posing as LivaNova recruiters or employees. The scammers may attempt to solicit confidential, personal information, such as a social security number, or your financial information. LivaNova will never ask for fees prior/during/after the application process, nor will we ask for banking details or personal financial information in return for the assurance of employment. If you are concerned that an offer of employment might be a scam or that the recruiter is not legitimate, please verify by searching for "See Open Jobs" on https://www.livanova.com/en-us/careers, and check that all recruitment emails come from an @livanova.com email address. | |