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. Convatec’s revenues in 2023 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 **Place of work:**  Priemyselný park 3, Michalovce, Slovakia. **Wage (gross) and other rewards: ** Minimum 1450€ / 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 **Contract type:**  full-time. **Start date:**  by agreement. **Position Overview:** This position is full- time role within Advanced Operations, which is part of the Global Operations and Quality function, working on projects leading to the introduction of new products and processes. Act as Validation Subject Master Expert specifically for new equipment introduction; developing validation strategies which ensure efficient and robust introduction of new equipment, ensuring documentation and validation activities meet the requirements of ISO13485:2016 and 21CFR 820 as well as alignment with Convatec SOPs. **Key Responsibilities:** + The Validation Engineer must participate early on in new product development project with the purpose to: + Achieve knowledge and information in relation to the product design + Achieve knowledge and background into assembly process, critical to process parameters and critical to quality attributes + Inputs into design of equipment/testing to optimize delivery of validation + Use in-depth process knowledge to help inform process FMEAs, tolerances, sampling plans + Draft Master Validation Plans (MVP) for new equipment and/or change control projects, with input from multiple functions to meet the standards required + Determine the most efficient and high quality validation strategies for both pilot and scale up manufacturing equipment, recommend and create validation and qualification approaches, strategies, priorities, with required timings & resource requirements + Liaise with software validation SMEs and supplier software design engineering to determine best software validation approach, and build into MVP + Ensure material availability and line side in readiness for validation + Ensure documentation in place and ready to run validation + Line side at FAT and SAT and IQ of equipment, with technical leads, engineers as required + Perform and carry out site based validation activities including where needed, overseeing, and or creation and execution of protocols /reports ion in compliance with Convatec QMS, specifically SOP-00096 (process validation) + Recommend early DOEs, trials on equipment to optimise delivery of validation downstream + Review the equipment URS’, assess the equipment proposals/designs to ensure a robust validation approach can be achieved + Train other engineers to meet expected standards in protocol writing and reporting, as required + Act as consult/reviewer and approver where needed for external manufactured NPI equipment validation plans and protocols in accordance with agreed SOPs, manufacturing vendor contracts and agreements + Establish and maintain the technical documentation throughout the project + Ensures knowledge and expertise around the product and key equipment processes are handed over to local site engineering/manufacturing + To ensure compliance with the legislative and internal requirements of the EHS and to participate in the fulfillment of the company's targets in the EHS area **Authority (if applicable):** + Role has signatory rights on plans, protocols and reports + Deviations as part of validation will require escalation and approval for recommendations/ decisions to higher management or within project team line of authority **Skills & Experience:** + Candidate should have strong analytical skills + Candidate must be a self-starter, with the ability to work independently and to deal with ambiguity + Candidate should have excellent oral and written communication skills with ability to build relationship and network. Work cooperatively and effectively with others + Positively influence others to achieve results that are in the best interest of the organization + Highly structured, capable of running lots of tasks in parallel + At least 2-5 years of relevant work experience as process, quality or validation engineer. + Knowledge and experience in operations, manufacturing, or engineering is essential. + Working with cross functional teams across R&D and Manufacturing **Preferred / Desired:** + Experience in equipment and process validation and capability studies + Experience with manufacturing quality – process FMEA, quality control **Qualifications/Education:** + Education at university level in engineering or scientific discipline **Desired** + Training in Six Sigma / Green Belt preferred. + Training in Lean Acceleration and streamline processes. + Project Management + Environmental and safety regulations + Must be proficient with PC programs i.e. Office (Excel, Word, and PowerPoint, Outlook/Teams), Statistical tools like Minitab, Project Management (Microsoft Project, etc.) **Training requirements** + Design control and validation standards + Advanced Statistical Techniques **Preferred training requirements** + Introduction training for administrative employees + Quality System documents and procedures relevant to all employees (local and Convatec corporate e.g. Code of Ethics and Business Conduct, Quality Policy, Complaints, relevant GxP documents), including regular re-training when required + Quality System documents and procedures relevant to job performance **Principal Contacts & Purpose of Contact** **Purpose of contact** For example: to exchange information; to explain policy; to make recommendations; to influence strategy or behavior changes **Internal** Local and Global R&D, Advanced Operations engineering, Global and Site based engineering, Manufacturing, EHS, Maintenance, Quality department, Regulatory, IT Exchange information / make recommendations **External** 3rd party Suppliers of materials, services, technology and equipment Exchange information / make recommendations **Travel Requirements** Position may involve travel, mostly within Europe but international travel may be expected. Some trips may include overnight travel and occasional long stays during machine buy off **Languages** + Speaking: Yes English & Slovak + Writing/Reading: Yes English & Slovak **Working Conditions:** Office based position with some home working flexibility. Home office following the local home office policy Frequent interactions to the shop floor / production area Some activity will be conducted at a supplier’s premises 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 + 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 0.44Eur 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 Email: job-slovakia@convatec.com convatec.sk | convatecgroup.com | careers.convatec.com \#LI-DS4 \#LI-Onsite **Beware of scams online or from individuals claiming to represent ConvaTec** A formal recruitment process is required for all our opportunities prior to any offer of employment. This will include an interview confirmed by an official ConvaTec email address. If you receive a suspicious approach over social media, text message, email or phone call about recruitment at ConvaTec, do not disclose any personal information or pay any fees whatsoever. If you’re unsure, please contact us at careers@convatec.com . **Dajte si pozor na podvody online alebo od jednotlivcov, ktorí tvrdia, že zastupujú spoločnosť ConvaTec** Pred akoukoľvek ponukou práce, sa vyžaduje formálny náborový process, pre všetky naše pracovné príležitosti. To bude zahŕňať, pracovný pohovor potvrdený oficiálnou e-mailovou adresou spoločnosti ConvaTec. Ak Vás osloví podozrivý kontakt cez sociálne médiá, textovú správu, e-mail, alebo telefonát, o nábore v spoločnosti ConvaTec, nezverejňujte žiadne osobné údaje, ani neplaťte žiadne poplatky. Ak si nie ste istí, kontaktujte nás na adrese careers@convatec.com . **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. **Rovnaké príležitosti** ConvaTec poskytuje rovnaké pracovné príležitosti, pre všetkých súčasných zamestnancov a uchádzačov o zamestnanie. Táto politika znamená, že nikto nebude diskriminovaný z dôvodu rasy, náboženstva, vierovyznania, farby pleti, národnostného pôvodu, národnosti, občianstva, pôvodu, pohlavia, veku, rodinného stavu, fyzického alebo mentálneho postihnutia, citovej, alebo sexuálnej orientácie, rodovej identity, vojenského statusu, alebo statusu veterána, genetických predisponujúcich vlastnosti, alebo z akéhokoľvek iného dôvodu, zakázaným zákonom. **Notice to Agency and Search Firm Representatives** ConvaTec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any ConvaTec employee by a third party agency and/or search firm without a valid written and signed search agreement, will become the sole property of ConvaTec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. **Upozornenie pre zástupcov agentúr a vyhľadávacích spoločností** Spoločnosť ConvaTec neprijíma nevyžiadané životopisy od agentúr a/alebo vyhľadávacích spoločností pre túto pracovnú ponuku. Životopisy predložené akémukoľvek zamestnancovi spoločnosti ConvaTec, treťou stranou, ako sú agentúry a/alebo vyhľadávacie spoločnosti, bez platnej písomnej a podpísanej zmluvy o vyhľadávaní, sa stanú výhradným vlastníctvom spoločnosti ConvaTec. **Already a ConvaTec employee?** **If you are an active employee at ConvaTec, please do not apply here. Go to the Career Worklet on your Workday home page and View "ConvaTec Internal Career Site - Find Jobs". Thank you!** **Ste už zamestnancom spoločnosti ConvaTec?** **Ak ste aktívnym zamestnancom spoločnosti ConvaTec, prosím, neaplikujte tadiaľto. Prejdite na stránku pracovných príležitosti, na svojej domovskej stránke Workday a zobrazte si „Interná kariérna stránka spoločnosti ConvaTec – Nájsť pracovné miesta“. Ďakujeme!** _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/_ _Na osobný pohovor budú pozvaní uchádzači, ktorí spĺňajú naše požiadavky. Materiály neoslovených uchádzačov budú v súlade s nariadením GDPR a so zákonom o ochrane osobných údajov skartované._ _Informácia o spracúvaní osobných údajov uchádzačov o zamestnanie sa nachádza na:_ _https://www.convatec.com/sk-sk/o-nas/kariera/_