Advanced Operations Validation Engineer

ConvaTec; London; On-site; GBP 40,000 - 60,000; Full time

Job summary

A global medical technology leader seeks an Advanced Operations Validation Engineer in London to ensure robust introductions of new equipment and processes. This full-time role requires collaboration with cross-functional teams, validation strategy development, and compliance with industry standards. The successful candidate will have a solid engineering background and the ability to drive results through analytical skills and effective communication.

Qualifications

• Minimum 2-5 years of relevant work experience as a validation engineer.
• Knowledge in operations and manufacturing is essential.
• Training in Six Sigma/Green Belt preferred.

Responsibilities

• Develop validation strategies for new equipment introduction.
• Participate in new product development and draft Master Validation Plans.
• Perform site-based validation activities in compliance with QMS.

Skills

Analytical skills

Communication skills

Process validation

Project Management

Team collaboration

Education

University degree in engineering or scientific discipline

Tools

Minitab

Microsoft Project

Office programs (Excel, Word, PowerPoint)

Job description

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Advanced Operations Validation Engineer, London

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Client:

ConvaTec

Location:

London, United Kingdom

Job Category:

Other

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EU work permit required:

Yes

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Job Reference:

3b1262158f88

Job Views:

5

Posted:

29.06.2025

Expiry Date:

13.08.2025

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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. Convatec’s 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

Change is everywhere at Convatec. It’s transforming our business, and helping us improve millions of lives. And we’re nowhere near finished. Across every part of our business, we’re pushing for better. Join us on our journey to #ForeverCaring as an AO Validation Engineer and you’ll 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 820as 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 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 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 supplier’s premises

Our transformation will change your career. For good.

You’ll bepushed to think bigger and aim for excellence. Your ideas will be
heard, and you’ll be supported to bring them to life.

There’ll bechallenges. 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 that’ll 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 you’re 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.