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Senior Specialist – Sterilisation
Unomedical s.r.o.
Place of work
Remote work
Remote work
Contract type
full-time
full-time
Start date
by agreement
by agreement
Wage (gross)
1 800 EUR/monthminimum 1800€ / monthly (depending on experiences and quality of the candidate) + Annual global incentive plan-bonus and other benefits in compliance with social benefit program of the company.
1 800 EUR/monthminimum 1800€ / monthly (depending on experiences and quality of the candidate) + Annual global incentive plan-bonus and other benefits in compliance with social benefit program of the company.
Information about the position
Job description, responsibilities and duties
About the role:
As a Senior Specialist – Sterilisation, you will work within prescribed GMP/ISO/GLP Standards and ensure compliance to all applicable national and international regulations. Position supports new and existing products and develops strategies and systems to support sterilization activities for Continence Care business unit. You will Provide sterilization engineering support to both existing manufacturing operations and new product development while working 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 as a Senior Specialist – Sterilisation:
• Ensure that the company contractual sterilization processes performed at contract sterilization sites are effective and in compliance with all current regulatory requirements.
• Manage, train, and develop site sterilization SMEs.
• Provide training on the QMS documents applicable for the area of sterilization as appropriate.
• Ensure the sterilization control being in compliance with all regulatory requirements, the relevant QMS procedures and/ or instructions maintained, and training provided.
• Provide product disposition in case of NC or discrepancy initiated during routine sterilization of the Continence Care manufactured products.
• Ensure validations and qualifications are prepared in due time and in cooperation with the functions involved in order to ensure their timely completion.
As a Senior Specialist – Sterilisation, you will work within prescribed GMP/ISO/GLP Standards and ensure compliance to all applicable national and international regulations. Position supports new and existing products and develops strategies and systems to support sterilization activities for Continence Care business unit. You will Provide sterilization engineering support to both existing manufacturing operations and new product development while working 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 as a Senior Specialist – Sterilisation:
• Ensure that the company contractual sterilization processes performed at contract sterilization sites are effective and in compliance with all current regulatory requirements.
• Manage, train, and develop site sterilization SMEs.
• Provide training on the QMS documents applicable for the area of sterilization as appropriate.
• Ensure the sterilization control being in compliance with all regulatory requirements, the relevant QMS procedures and/ or instructions maintained, and training provided.
• Provide product disposition in case of NC or discrepancy initiated during routine sterilization of the Continence Care manufactured products.
• Ensure validations and qualifications are prepared in due time and in cooperation with the functions involved in order to ensure their timely completion.
Employee perks, benefits
• Annual global incentive plan-bonus.
• Large corporation with representation and manufacturing plants in the world.
• Stable employer for Michalovce city and its surroundings.
• Corporate culture – Underpinning everything we do are our values:
• Flexible working hours.
• Introduction program according to company standards.
• Development trainings.
• Career opportunities for internal employees.
• Referral bonus system.
• Recognition program.
• 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.
• Social fund (various support and perks for employees).
• Various events / team building activities for employees.
• Various employee discounts by vendors within Michalovce city.
• Large corporation with representation and manufacturing plants in the world.
• 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
• Flexible working hours.
• Introduction program according to company standards.
• Development trainings.
• Career opportunities for internal employees.
• Referral bonus system.
• Recognition program.
• 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.
• Social fund (various support and perks for employees).
• Various events / team building activities for employees.
• 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/
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)
University education (Master's degree)
Educational Specialization
BS in Microbiology preferred. BA/BS in appropriate Science, Mathematics or Engineering.
Language skills
English - Upper intermediate (B2)
Personality requirements and skills
About you:
• Experienced about ethylene oxide and radiation principles and industry standards.
• Experienced in sterilization process controls.
• 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.
• Trained in FDA QSR’s, MDSAP, ISO 13485, EU and Canadian medical device regulations (preferred).
• Lead Auditor (preferred).
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.
• Communicative level of English language.
Working Conditions:
Remote working – Occasional expectation to visit operations in Slovakia.
Position may involve travel up to 25% of the time, mostly within Europe but overseas travel is expected.
Our ambitions will bring the very best out in you. You’ll be pushed to aim higher and really own your work. You’ll be encouraged and supported to make things happen, too. It can be challenging. But, as the progress you make will help improve the lives of millions, it’ll be worth it.
This is stepping up to a challenge.
This is work that’ll move you.
• Experienced about ethylene oxide and radiation principles and industry standards.
• Experienced in sterilization process controls.
• 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.
• Trained in FDA QSR’s, MDSAP, ISO 13485, EU and Canadian medical device regulations (preferred).
• Lead Auditor (preferred).
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.
• Communicative level of English language.
Working Conditions:
Remote working – Occasional expectation to visit operations in Slovakia.
Position may involve travel up to 25% of the time, mostly within Europe but overseas travel is expected.
Our ambitions will bring the very best out in you. You’ll be pushed to aim higher and really own your work. You’ll be encouraged and supported to make things happen, too. It can be challenging. But, as the progress you make will help improve the lives of millions, it’ll be worth it.
This is stepping up to a challenge.
This is work that’ll move you.
Advertiser
Brief description of the company
Pioneering trusted medical solutions to improve the lives we touch: Unomedical s.r.o. is a member of Convatec which 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!
To find out more please visit https://careers.convatec.com - thanks for your interest!
Number of employees
500-999 employees
Contact
ID: 4750947
Dátum zverejnenia: 25.3.2024
2024-03-25
lokalita: Remote work Pozícia: Auditor, ISO Specialist, Laboratory Technician, Medical Laboratory Technician Spoločnosť: Unomedical s.r.o.
Základná zložka mzdy (brutto): 1 800 EUR/month