About the role:
Are you an experienced microbiology and sterilization expert looking to make a global impact? This is an exciting opportunity to lead microbiological and environmental programs across multiple manufacturing sites, shape best practices, drive harmonization across business units, and influence the future of quality and sterility assurance within a highly regulated healthcare environment.
Your key duties and responsibilities:
Technical Leadership
- Serve as the global subject matter expert (SME) for microbiology, environmental monitoring, contamination control, and sterilization processes.
- Lead the development and implementation of global microbiological remediation and maintenance strategies across multiple manufacturing facilities and business units.
- Evaluate emerging technologies, industry developments, and regulatory trends to continuously enhance microbiological control programs.
- Drive complex technical investigations involving microbial excursions, contamination events, sterility assurance concerns, and environmental monitoring trends.
- Provide scientific leadership and strategic direction for sterilization validation, requalification, and routine monitoring programs.
Environmental Monitoring & Contamination Control
- Lead environmental monitoring programs across controlled manufacturing environments, ensuring robust contamination control practices.
- Develop and implement risk-based contamination control strategies and microbiological surveillance programs.
- Analyse environmental monitoring data, identify trends, and drive impactful corrective and preventive actions.
- Ensure ongoing compliance with regulatory requirements, industry standards, and internal quality expectations.
- Support facility design, qualification, and operational improvements to maintain world-class microbiological controls.
Sterilization Validation Support
- Provide expert guidance for sterilization processes, including validation, routine monitoring, control activities, and change management initiatives.
- Support a range of sterilization technologies, including ethylene oxide (EO), radiation, steam, and other applicable modalities.
- Lead assessments related to sterility assurance, bioburden control, microbial characterization, and validation studies.
- Partner with internal stakeholders and external sterilization providers to ensure compliance, efficiency, and operational excellence.
- Support regulatory inspections, customer audits, and third-party audits related to sterilization activities.
Quality & Regulatory Compliance
- Ensure compliance with FDA, ISO, EU MDR, GMP, and other applicable regulatory requirements.
- Author, review, and approve technical reports, protocols, risk assessments, procedures, and validation documentation.
- Support regulatory submissions and responses involving microbiology and sterilization activities.
- Act as a key technical representative during regulatory inspections and quality audits.
- Champion safety, health, and environmental standards in accordance with established EHS requirements.
- Drive adherence to Quality Management Systems based on ISO 13485 and FDA cGMP regulations.
Cross-Functional Leadership
- Collaborate with site and corporate quality teams to harmonize microbiological standards and best practices globally.
- Mentor, coach, and support the development of microbiologists and quality professionals across the organization.
- Lead or contribute to strategic initiatives, new product introductions, site expansions, and continuous improvement programs.
- Present technical recommendations, risk assessments, and strategic insights to senior leadership.
Skills & Experience:
- 10+ years of experience in microbiology, sterilization, sterility assurance, or contamination control within highly regulated industries.
- Significant experience supporting medical device, pharmaceutical, biologics, or healthcare manufacturing environments.
- Proven ability to lead complex investigations, root cause analyses, and microbiological risk assessments.
- Experience supporting multiple manufacturing sites and collaborating across global business functions.
- Ability to thrive in a complex, fast-paced environment while delivering high-value results and driving business impact.
- Strong leadership skills with the ability to prioritize competing demands and influence stakeholders at all levels.
- Excellent written and verbal communication skills, with the ability to communicate complex scientific concepts clearly.
- Fluent in English, both written and spoken. Spanish is a plus.
- Experience collaborating with global teams across the Dominican Republic, UK, Denmark, Slovakia, US, and Mexico.
- Strong cross-cultural communication and relationship-building skills.
- Experience within the Medical Devices industry is preferred.
- Background in quality systems, engineering, process validation, and continuous improvement methodologies.
- Experience applying structured problem-solving techniques to complex technical challenges.
- Proficiency with Microsoft Office applications, electronic document management systems, and quality management tools.
Qualifications/Education:
- B.S in Microbiology, Biological Sciences, Biomedical Engineering, or related scientific discipline preferred.
- Master's degree with extensive relevant experience may be considered.
Travel Requirements:
- Availability to travel to Haina's manufacturing site.
- Position may involve travel up to 10% of the time, overseas travel is expected, and most trips will include overnight stays.
Working Conditions:
- Remote working in Dominican Republic.
- May need to support global discussions in different time zones or impromptu audits
Ready to join us?
At Convatec, we’re pioneering trusted medical solutions to improve the lives we touch. If you’re ready to make a real impact, apply today and help us bring our Forever Caring promise to life.
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Equal opportunities
Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.
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About Convatec
Pioneering trusted medical solutions to improve the lives we touch:
Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in Advanced Wound Care, Ostomy Care, Continence Care, and Infusion Care. With over 10,000 colleagues, we provide products and services in around 90 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention, treatment for hard to heal wounds, at-risk skin and ulcerated tissue to supporting debilitating conditions, improved patient outcomes and reduced care costs. Convatec's revenues in 2025 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more please visit: http://www.convatecgroup.com.
