CCC Corporate Sterilization Specialist

Unomedical s.r.o.

Place of work
Priemyselný park 3, Michalovce
Contract type
full-time
Start date
by agreement
Wage (gross)
1 500 EUR/monthminimum 1500€ / monthly (depending on experiences and quality of the candidate) + quarterly bonus and other benefits in compliance with social benefit program of the company

Information about the position

Job description, responsibilities and duties

At ConvaTec, our vision is to develop pioneering trusted medical solutions to improve the lives we touch. We are a global medical technology business focused on serving people and care givers in the areas of advanced wound care, ostomy care, continence and critical care and infusion care. We devise, develop and manufacture innovative products and services that support people with deeply personal and challenging medical conditions, helping to improve care for them and giving them greater confidence, freedom and mobility.

We are guided by our five core values, that shape the way we work, every day: Improve Care, Deliver Results, Grow Together, Own It and Do What’s Right. We are a global Group, with over 9,900 employees and in 2020, our Group generated revenues of over $1.894 billion. To learn more about ConvaTec, please visit www.convatecgroup.com.


Every day, our products improve the lives of millions of people around the world. We’re hugely proud of this, which is why we’re transforming our business to reach millions more. Join us as a CCC Corporate Sterilization Specialist, and you’ll drive progress that really means something.


About the role:
Works within prescribed GMP/ISO/GLP Standards and ensures compliance to all applicable national and international regulations. Position supports new and existing products and develops strategies and systems to support sterilization activities for Critical and Continence Care business unit. Provides sterilization engineering support to both existing manufacturing operations and new product development. Works with manufacturing and development teams to evaluate, develop and validate appropriate sterilization processes. Position will have the opportunity to support operations on programs within the cleanrooms and interact with Operations and technical teams on trending, excursions and assessing the impact of environmental or device changes. This role has a direct impact on the quality of existing products, as well as, products during design and development.

Your key duties and responsibilities:
• Responsible for sterilization duties in the Critical and Continence Care business units and mentoring/assisting the local SMEs in both Critical Care and Continence Care business units specific activities
• Develops, control and implements systems, procedures, and business unit strategies relating to sterilization for the Critical and Continence Care business
• Train and mentor local business unit sterilization SMEs along with quality, regulatory, manufacturing, and R&D personnel in sterilization concepts, practices, and approaches
• Works within prescribed GMP/ISO/GLP Standards and assures compliance to all applicable regulations
• Provides technical solutions to product development teams and manufacturing using microbiological and sterilization theory and practice
• Designs, validates and implements sterilization processes taking into consideration sterility assurance, modality compatibility, product and packaging functionality and process compatibility
• Provides support for manufacturing related sterilization operations, interacting with contract sterilizers and test facilities
• Provides technical guidance on sterilization needs to Research and Development on new product development
• Supports manufacturing site environmental control programs by establishing trend reviews, responding to excursions and assessing impact of changes to products, process and environment
• Assists in conducting technical audits of suppliers, contract manufacturers and laboratories
• Participates in internal and external audits as subject matter expert defending sterilization and environmental control processes and activities
• Delivers results and drives continuous improvement. Sets high performance goals and holds self accountable for those results

Employee perks, benefits

• Quarterly bonus after the trial period - max. 10% from the monthly salary of the employee (based on the results of the production plant)
• Large corporation with representation and manufacturing plants in the world
• Very stable employer for Michalovce city and its surroundings
• Corporate culture – Underpinning everything we do are our values:
- Improve care
- Deliver results
- Grow together
- Own it
- Do what´s right
• Meals in the amount of 0.17 Eur per one meal unit / day
• Supplementary pension plan after the trial period with the employer's contribution
• Free bus transport within Michalovce city
• Social fund (various support and perks for employees)
• Flexible working hours
• Development trainings
• Career opportunities for internal employees
• Various events / team building activities for employees (no pandemic situation)
• Various employee discounts by vendors within Michalovce city

Information about the selection process

Please send your CV only in English language.

Only candidates who meet our requirements will be invited for the interview. Data of not selected candidates will be deleted in compliance with GDPR and data protection law.
Information about personal data processing of job seekers is located on link: http://www.convatec.sk/o-nás/kariéra/

Requirements for the employee

Candidates with education suit the position

University education (Bachelor's degree)
University education (Master's degree)

Educational Specialization

BS in Microbiology preferred. BA/BS in appropriate Science, Mathematics or Engineering accepted, or 5 years or more experience if no appropriate science degree

Language skills

English - Upper intermediate (B2)

Personality requirements and skills

About you:
• Have a minimum of three years, preferred five years, hands on experience in designing, validating and implementing sterilization processes and microbial and sterility testing within medical device/pharmaceutical manufacturing
• Have a working knowledge of GMP/ISO/GLP guidelines as applied to medical device sterilization
• Have hands on experience in monitoring and maintenance of validation of controlled environment using current guidelines and regulations
• Have provision of scientific data to support manufacturing, resolve non-conforming issues and ensure adequate corrective and preventive actions
• Have general leadership skills to organize complex work schedules
• Have the ability to work with people and teams in a complex, changing environment and be able to deliver value added results to the business on time
• Be fully competent in oral and written communications including strong documentation skills
• Flexibility is required if needed
• Travel requirements: 20-30% (no pandemic situation)
• Visits to contract sterilization units will be required


Education / Qualifications:
• BS in Microbiology preferred. BA/BS in appropriate Science, Mathematics or Engineering accepted, or 5 years or more experience if no appropriate science degree
• Demonstrates knowledge of ethylene oxide and radiation validation principles and industry standards and experience in sterilization process controls is a must
• Demonstrates expert technical knowledge of working within a controlled manufacturing environment and has experience in monitoring and maintenance of systems validation of controlled environments using national and international standards


Our products make a big difference every day. So will your contribution. The work you do will mean more, because it’ll make things better for your team, our business or our customers’ lives. It’ll inspire you to deliver to your very best.
And we’ll be right behind you when you do.

This is a challenge more worthwhile.
This is work that’ll move you.

Advertiser

Brief description of the company

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 around 10,000 colleagues, we provide our products and services in almost 100 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Group revenues in 2022 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more about Convatec, please visit http://www.convatecgroup.com

To find out more please visit https://careers.convatec.com - thanks for your interest!

Number of employees

500-999 employees
ID: 4062159  Megjelentetés dátuma: 15.4.2021  Alapbér (bruttó): 1 500 EUR/month