Validation Engineer II

Job description

**About Convatec**

**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 more than 10,000 colleagues, we provide our products and services in around 90 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 2024 were over $2 billion.

The company is a constituent of the FTSE 100 Index (LSE:CTEC).

To learn more please visit http://www.convatecgroup.com

**Position Overview:**

The Validation Engineer will participate in the process development of projects related with capacity upgrade of existing products and processes, R/D for new products, update of existing products and Revalidation Process Manufacturing.

**Key Responsibilities:**

**Technical project documentation and activities:**

· Participate in Change Control Process (CCRs) for new projects involving the
Project Engineering Department.
· Develop, establish, maintain, modify, and handle the technical project
documentation according to BUIC DK/ UMID MX process development procedure
· Participate in gathering the necessary documentation for closure of CCRs
· Create, develop and conduct process validation activities.
· Coordinate production runs, test runs and any other related activities to process
validations.
· Initial validation of new process equipment, if required based on risk assessment.
· Re-validation method and frequency as defined (VMP).
· Regular follow up on re-validation plans and that re-validation is performed (VMP).
· Assure proper review / approval of validation documentation.

Quality documentation and activities:
· Participate in writing Process FMECA (P-FMECA)
· Responsible for documentation- and performing Factory Acceptance Test (FAT) and Site Acceptance Test (SAT) in cooperation with the BUIC DK/ UMID MX project team and other relevant SMEs e.g., other involved project managers and production sites.
· Create validation documentation for New processes, tools, machines, and materials according to local procedures.
· Transferred projects.
· Re-validation according to instructions and forms for process validation, relevant P-FMECAs and other relevant documents.
· Perform validation based on above documents in cooperation with the BUIC DK and/or UMID MX project team and, if relevant, other involved parties e.g., project managers and other production sites.
· Perform necessary training of employees participating in validation activities.

**About you:**

**Skills and Experience:**

· About 3 years of experience in similar position.

· Experience with performing risk analysis.

· Experience with validation of process equipment.

· Knowledge of the basic requirements of the FDA QSR, GMP, GAMP, ISO13485 and ISO11607-2.

· Basic knowledge in Minitab.

· Advanced knowledge of Excel (pivot tables, graphs, formulas, macros etc.)

**Qualifications/Education:**

· Bachelor's Degree in Industrial Engineering, Mechatronics, Electronics, Mechanical Engineering, or a related field.

**What you’ll get:**

•Competitive salary + bonus

•Training & development

•Collaborative, supportive culture

**Ready to join us?**

At Convatec, we’re pioneering trusted medical solutions to improve the lives we touch.

If you’re ready to make a real impact, apply today and help us bring our Forever Caring promise to life.

**Qualifications & Education:**

Professional Degree required.

#LI-SR1
#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 .

**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.

**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!**

Required Skill Profession

Other General