Senior Validation Engineer (Manufacturing Integration)

Validation Engineer

Location: Mostly Remote - Switzerland (with occassional travel across Switzerland and Germany)
Contract: 12-month initial contract, with a further 12 months likely

The Opportunity

We are seeking an experienced Validation Engineer to support a major medical device manufacturing integration, transfer and scale-up programme across Switzerland and Germany.

The programme involves transferring and integrating existing manufacturing processes into a wider manufacturing and quality environment, alongside a significant increase in production volumes.

The successful candidate will play a key role in reviewing existing validation strategies, assessing inherited validation documentation and ensuring manufacturing processes and supplier activities meet the required quality, compliance and regulatory standards.

Working across internal manufacturing operations and external suppliers, you will identify validation gaps, recommend remediation activities and support additional qualification and validation work where required.

This is a broad validation position rather than a technology-specific role. We are looking for someone with strong validation and quality engineering expertise who can assess different manufacturing processes, challenge existing documentation and work with technical specialists to address any deficiencies.

Key Responsibilities

• Review manufacturing and supplier validation strategies, protocols, reports and supporting documentation.
  
  

• Assess existing validation packages associated with manufacturing and process transfers, identifying compliance, technical and documentation gaps.
  
  

• Develop and implement remediation plans to address validation deficiencies and ensure alignment with quality and regulatory requirements.
  
  

• Support process qualification and validation activities, including Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).
  
  

• Provide validation oversight across manufacturing transfers, production scale-up activities and process changes.
  
  

• Review validation activities across internal assembly operations and external manufacturing suppliers.
  
  

• Assess supplier validation processes covering injection moulding, CNC machining, laser cutting, mechanical and electronic assembly, polymer-based manufacturing and specialist manufacturing processes.
  
  

• Review and support Measurement System Analysis (MSA) and associated measurement and inspection strategies.
  
  

• Ensure validation documentation, traceability and objective evidence are maintained to support quality and regulatory audits.
  
  

• Provide practical recommendations to improve legacy or transferred validation packages.
  
  

• Support the development of robust validation strategies capable of accommodating increased manufacturing volumes.
  
  

• Manage validation activities across multiple sites and suppliers, maintaining visibility of risks, priorities, gaps and required actions.
  
  
  
  

Required Experience & Skills

• Degree in Engineering, Quality, Manufacturing, Science or a related technical discipline.
  
  

• Strong Validation Engineering experience within a regulated manufacturing environment, ideally medical devices.
  
  

• Demonstrable experience in process validation and equipment/process qualification, including IQ, OQ and PQ.
  
  

• Strong understanding of validation lifecycle principles and risk-based validation methodologies.
  
  

• Experience reviewing existing or inherited validation packages and identifying compliance and documentation gaps.
  
  

• Previous involvement in manufacturing transfers, process transfers, production scale-up or site integration programmes.
  
  

• Strong understanding of regulated Quality Management Systems and medical device manufacturing requirements.
  
  

• Experience working with external manufacturing suppliers and/or contract manufacturers.
  
  

• Working knowledge of Measurement System Analysis (MSA) and quality engineering methodologies.
  
  

• Ability to assess validation approaches across different manufacturing technologies without needing to be the technical specialist in every process.
  
  

• Strong technical documentation, review and stakeholder management skills.
  
  

• Ability to work autonomously across engineering, quality, manufacturing and supplier teams.
  
  

• Willingness and flexibility to travel regularly across Switzerland and Germany.
  
  
  
  

Desirable Experience

• Previous experience within the medical device industry, particularly Class II or Class III products or similarly regulated technologies.
  
  

• Experience supporting manufacturing or quality integration following an acquisition, site transfer or organisational integration.
  
  

• Exposure to injection moulding, CNC machining, laser cutting, mechanical assembly, electronics or polymer-based manufacturing.
  
  

• Experience working across multi-site or international manufacturing programmes.
  
  

• Knowledge of ISO 13485, process validation expectations and risk management principles within regulated medical device manufacturing.
  
  
  
  

Ideal Candidate Profile

The ideal candidate will be a pragmatic and experienced Validation Engineer who can enter an evolving programme, quickly understand existing validation arrangements and independently determine where improvements are required.

You will bring broad validation expertise rather than specialising in one particular manufacturing technology. You should be confident reviewing complex validation packages, challenging existing evidence, identifying potential risks and working alongside subject matter experts to close gaps.

This is an excellent opportunity for someone who enjoys working across multiple manufacturing environments, managing supplier relationships and delivering validation improvements within a large-scale international manufacturing programme.

About Korn Ferry

Korn Ferry unleashes potential in people, teams, and organizations. We work with our clients to design optimal organization structures, roles, and responsibilities. We help them hire the right people and advise them on how to reward and motivate their workforce while developing professionals as they navigate and advance their careers. To learn more, please visit Korn Ferry at www.Kornferry.com