Engineer - Validation

Engineer - Validation

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:

This role is a local role, and the holder of this position is responsible for:

• 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.

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

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.

Note: Please send your CV only in English language.

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.
• 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.

Company: Unomedical s.r.o. (member of the global company Convatec) Priemyselný park 3 071 01 Michalovce, Slovakia

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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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