Job Description

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 atrisk skin, to improved patient outcomes and reduced care costs. Convatecs revenues in 2024 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
Change is everywhere at Convatec. Its transforming our business, and helping us improve millions of lives. And were nowhere near finished. Across every part of our business, were pushing for better. Join us on our journey to #ForeverCaring as an AO Validation Engineer and youll do the same
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
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 suppliers premises

Our transformation will change your career. For good.
Youll be pushed to think bigger and aim for excellence. Your ideas will be
heard, and youll be supported to bring them to life.
Therell be challenges. But, stretch yourself and embrace the opportunities, and
you could make your biggest impact yet.
This is stepping outside of your comfort zone.
This is work thatll move you.
#LI-DS4
#LI-Hybrid
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 youre unsure, please contact us at .
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.
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.
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