Engineer - Validation

Náplň práce, právomoci a zodpovednosti:

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 an Engineer - Validation, and you’ll drive progress that really means something.


About the role:

Position is supposed to cover validation of manufacturing processes in manufacturing units to be performed meeting  predefined project timeline  and in compliance with SOPs and standards.

This is one of the key positions for realizing the first production and products of good quality and to the specification within defined frame of set ups.

Your key duties and responsibilities as an Engineer - Validation:

• Validation of new production processes (except IQ) for the newly transferred processes and equipment preferably but not limited to.

• Cooperation with the transfer project team  and  others department to ensure smooth validation process.

• Re-validation of the processes as per time plan.

• Ensure availability of all necessary procedures, instructions, and forms according the rules and requirements and their compliance through validation/revalidation of the processes in manufacturing unit.

• Author for Validation Plans , Validation Protocols and Reports.

• Updating and creating machine cards.

• To conduct/support a process investigation, to recognize the inputs and outputs to the process by using a structured approach and tools such as process map, risk assessments, e.g. FMEA, Ishikawa diagram, flow charts.

• To process and understand statistical data.

• Providing regular updates to relevant manager and a project leader .

Zamestnanecké výhody, benefity:

• 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.

• 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 

• Convatec Day – extra day off.

• Home office possibilities.

• 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 0.44 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).

• Free bus transport within Michalovce city.

• Various events / team building activities for employees.

• Various employee discounts by vendors within Michalovce city. 

Informácie o výberovom konaní:
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: https://www.convatec.com/sk-sk/o-nas/kariera/

Požiadavky na zamestnanca:

About you:

• Mandatory:

  • Minimum 1 year experience with quality management system (e.g. ISO 13485, ISO 9001) in production  – internship acceptable

• Big advantage:

  • Knowledge and experience in engineering, and statistical tools – especially in the medical devices industry

  • Experience with risk assessment tools (e.g. PFMEA)

  • Experience in process validation and capability

• Advantage:

  • Relevant work experience as process, technology, or quality engineer

  • Technical background from manufacturing

  • Knowledge of root cause analysis tools

Education / Qualifications:

• Mandatory:

  • Proficient with PC programs i.e. Office (Excel, Word, and PowerPoint)

  • Communicative level of English language

  • Minimum 1 year experience with quality management systems (cGMP) 

  • Master’s or advanced degree preferred in Technical / Engineering or Quality Management/Engineering 

• Big advantage: 

  • QMS systems (e.g. ISO 13485, ISO 9001) and cGMP understanding 

  • Experience with risk assessment tools (e.g. PFMEA)​

  • Basic statistical tools (e.g. Minitab)

• Advantage:

  • Technical background from manufacturing

  • Knowledge of root cause analysis tools

  • SAP knowledge

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.