Validation Engineer

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

**The role:**

The Validation Engineer is responsible for commissioning and qualification of processes and manufacturing equipment.

The Validation Engineer will participate in projects within:

+ Capacity upgrades of existing processes and manufacturing equipment including customer projects.
+ New manufacturing equipment or facilities.
+ For new and existing products.
+ Capacity upgrades of existing molds.
+ Advanced Operations.
+ Revalidation of existing processes.
+ Periodic System Review and periodic revalidations to ensure validated state of processes and manufacturing equipment.

The Validation Engineer will participate from the first stages and throughout the projects with the purpose of:

+ Ensure presence of and/or establish a clear User Requirement Specification.
+ Achieving knowledge and information regarding the product, process and/or manufacturing equipment design.
+ Achieving knowledge and background information regarding technical processes and technical solutions.
+ Contribute to select technical solutions for handling, processing and verifications which may be subjects for commissioning and qualification.
+ Establish and maintain relevant documentation throughout the project.
+ Write execute and report test activities required during commissioning and qualification of the processes and/or manufacturing equipment – including testing of embedded software.

**Key Responsibilities:**

+ Contribute to User Requirement Specification (URS), purchase, and implementation of processes and/or manufacturing equipment.

+ Provide support for review and input for the Design Documents in according with cGAMP; Software Design Specifications, Hardware Design Specifications, Functional Design Specification.
+ Ensure execution of Equipment Design Verification (Design Review) based on the Design Documents.
+ Document and handle deviations identified during Commissioning (Factory Acceptance Testing and Site Acceptance Testing) and Qualification (IQ, OQ and PQ).
+ Participate in Commissioning (Factory Acceptance Testing and Site Acceptance Testing) and Qualification (IQ, OQ and PQ) activities in accordance with local and global company policies and procedures.
+ Support inputs to PFMEAs and project plans within Manufacturing Process Validation.
+ Writing and execution of specific protocols for IQ, OQ, PQ and periodic revalidations.
+ Perform Qualification and Validation according to applicable regulation and internal procedures.
+ Implement new and existing Validation activities including manufacturing equipment, processes, test equipment, molds, products, and facility within agreed timescales.
+ Adhere to all necessary standard operating procedure for Convatec IC processes and applicable regulation.
+ Ensure compliance with the legislative and internal requirements of the local EHS during projects including CE marking.
+ Effectively work with cross functional site teams.
+ Guidance and support for maintaining current state of site-specific Validation through continuous process verification.
+ Write Periodic System Review reports and periodic revalidation protocols and reports according to IC and global company policies and procedures.
+ Provide relevant input for Change Control Records.
+ Travel when procuring new manufacturing and/or process equipment to ensure build is carried out according to URS deliverables.
+ Travel when executing equipment Factory Acceptance Testing, Site Acceptance Testing and Validation of the manufacturing and/or process equipment.
+ Support during development of BUIC Quality Documents (procedures, work instructions, forms etc.) such as, but not limited to, cGAMP documents, URS, Design Review, Commissioning and Validation.

**Skills & Experience:**

Key competencies and characteristics candidates need to demonstrate to help build our diverse, inclusive culture and to be successful in the role.

These may include:

+ Degree in relevant discipline.
+ Experience with ISO 13485 and FDA requirements preferred.
+ Act with integrity, escalate the issues when company strategical interest or compliance are at risk.
+ Comprehension of the Validation life cycle and how it can be applied efficiently and remain compliant on local level.
+ Experience with equipment, process, mold and/or design Validation preferred.
+ Understanding of Good Manufacturing Practice (GMP), current Good Automated Manufacturing Practice (cGAMP), and Quality Systems in a regulated environment.
+ Ability to communicate effectively with individuals at site levels and provide a proactive approach to solving problems.
+ Have technical knowledge and understanding to ensure sufficient challenge of the processes or manufacturing equipment written into the test plans for Commissioning and Qualification.
+ Have full understanding of testing requirements, product and material specifications, drawings, and related documentation to ensure compliance.

**Qualifications/Education:**

+ Education as Engineer, Laboratory Technician, or other relevant technical background.
+ Minimum 3 years of experience from similar position – preferred.
+ Fluent English, verbal and written.
+ Knowledge of basic requirements of GMP, cGAMP and ISO 13485 or similar regulations – required.
+ Experience working with validation in a regulated industry – preferably from medical device or pharma industry, alternatively other industries with legislative regulations and related documentation.
+ Experience with production equipment technologies within medical devices or other relevant industries.

Preferred experience with calibration, measurement techniques and statistics.
+ Preferred experience with CE marking of process equipment in accordance with current machinery directive.
+ Specific software skills – MS Excel, MS Project, MS PowerPoint, MS Word.

**Travel Requirements**

Travel activity is to be expected, visiting suppliers in primarily Denmark or Scandinavia, or project activities in at other Convatec sites.

Any travel activities will be agreed in timely manner with direct report.

**Languages**

+ Speaking: English Danish*

+ Writing/Reading: English Danish*

*Additional language - not required, nice to have.

**Working Conditions**

+ Hybrid working 1-2 days per week working from home driven by business requirements as Convatec has a flexible approach of working.
+ This position is relevant in manufacturing facility from an office, including clean room manufacturing facility which produces medical device.

Adherence to EHS & Quality standards in these areas will be mandatory.
+ Office based “Hybrid Office Environment” based upon the agreement with direct report.

**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.

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#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