Advanced Operations Validation Engineer

Náplň práce, právomoci a zodpovednosti:

Travel Requirements:

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

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

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

Zamestnanecké výhody, benefity:

• 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:
- 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 0.44 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:
Note: 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: https://www.convatec.com/sk-sk/o-nas/kariera/

Požiadavky na zamestnanca:

About you:

• 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

Languages:

• Speaking:                  Yes                 English/Slovak

• Writing/Reading:       Yes                 English/Slovak

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.